08/23/2010 - Five days before a 2007 article in the New England Journal of Medicine showed that the diabetes drug Avandia was linked to a 43% increase in heart attacks compared with other medications or placebos, a group of scientists and executives from the drug's maker, GlaxoSmithKline (GSK), gathered in a conference room at the offices of the Food and Drug Administration in White Oak, Md. The GSK goal: to convince regulators that the evidence that the company's $3 billion-a-year blockbuster drug caused heart problems was inconclusive. To do that, the GSK officials focused not on heart-attack data but on a broader, less well defined category of heart problems called myocardial ischemia. More>>>
07/23/2010 - More than nine out of 10 scientists who backed a drug at the centre of a safety scare had financial links to the pharmaceutical industry, a study has found. More>>>
07/20/2010 - One of the three panelists who recommended that the U.S. Food and Drug Administration allow GlaxoSmithKline to continue marketing Avandia with no further restrictions is a paid speaker for the drug company, reports The Wall Street Journal. More>>>
07/16/2010 - It remains unclear whether the most closely watched FDA advisory panel in years will prove to be the death knell or a life raft for rosiglitazone. More>>>
07/14/2010 - Federal advisers delivered a mixed verdict Wednesday on the diabetes drug Avandia, with a significant number of experts voting to recommend that it be pulled from the market because of safety concerns but a majority urging to keep it available, perhaps with tough new restrictions and new warnings. More>>>
07/12//2010 - A large clinical trial of Avandia, sponsored by its maker, "was inadequately designed and conducted to provide any reassurance" that the controversial diabetes drug does not increase cardiovascular risk, a Food and Drug Administration scientist wrote in a memo released Friday. More>>>
07/12//2010 - The popular diabetes drug Avandia may be far more dangerous to patients than reported in a study touted by the drug's manufacturer, according to a strongly worded report posted Friday by the Food and Drug Administration. More>>>
07/09/2010 - The drug maker GlaxoSmithKline misinterpreted crucial details of a study finding that Avandia, its blockbuster diabetes drug, is safe, a medical reviewer for the Food and Drug Administration said Friday. More>>>
07/06/2010 - The count down to the re-review of GlaxoSmithKline plc's controversial diabetes pill Avandia has begun! More>>>
06/01//2010 - GlaxoSmithKline Plc has settled thousands more lawsuits brought by patients alleging its Avandia diabetes drug caused heart attacks, in a move that may defuse potentially massive claims over the medicine. More>>>
05/20//2010 - GlaxoSmithKline PLC is facing difficulties recruiting patients in the U.S. for a large clinical trial of its diabetes drug Avandia, in the wake of several studies linking the medicine to an increased risk of heart attack. More>>>
05/11//2010 - An major trial of Avandia puts patients at risk and should be stopped, a U.S. advocacy group said on Tuesday in calling on regulators to halt the global study of the controversial GlaxoSmithKline Plc diabetes drug.More>>>
05/10//2010 - GlaxoSmithKline Plc agreed to pay about $60 million in the first settlements of lawsuits alleging the company’s Avandia diabetes drug causes heart attacks and strokes in some users, people familiar with the accords say. More>>>
04/21/2010 - GSK’s Avandia just won’t stay out of the news. Now comes a report from The Wall Street Journal that the FDA is considering dealing the beleaguered diabetes drug another blow by stopping one of its safety trials. The TIDE trial, which received approval in 2007, pits Avandia (rosiglitazone) against Takeda’s Actos (pioglitazone), a drug that as yet hasn’t suffered from the same safety pitfalls. More>>>
04/20/2010 - U.S. regulators are reviewing the safety of GlaxoSmithKline P.L.C.'s Avandia diabetes drug as they weigh whether to suspend a trial testing the medicine, Bloomberg News reported. The Food and Drug Administration is reassessing a study comparing Avandia with a rival medicine from Takeda Pharmaceutical Co., and whether it is ethical to pursue the research after studies tied the Glaxo drug to an increased heart attack risk, according to a letter from FDA Commissioner Margaret Hamburg, dated March 30, the news service said. More>>>
04/19/2010 - The Food and Drug Administration is weighing whether to halt a safety study involving thousands of patients taking GlaxoSmithKline PLC's Avandia diabetes drug, a decision that could also determine whether the drug stays on the U.S. market. Studies during the past three years have tied the medicine to an increased risk of heart attacks. More>>>
04/15/2010 - A new analysis of reviews and articles about the controversial diabetes drug Avandia has found that experts who were paid by its manufacturer have been significantly more likely than others to draw positive conclusions about the drug’s safety and efficacy. More>>>
03/31/2010 - Diabetes is particularly detrimental to the heart, and heart problems are the eventual cause of death for most patients with diabetes. Given this, it is extremely worrisome that Avandia, a drug marketed to treat diabetes, has been found to harm the heart. More>>>
03/25/2010 -Avandia is a diabetes drug that is usually given to senior citizens. It helps control blood sugar levels by making the cells of the body more sensitive to the action of insulin. Avandia is for people with Type 2 (non-insulin dependent) diabetes. It is sometimes used in combination with other medications, but it is not for treating Type 1 diabetes. However, there are recent studies that Avandia is harmful for the heart, and increases the chances of getting a heart attack. More>>>
03/22/2010 - Saudi Arabia has suspended GlaxoSmithKline's (GSK.L) diabetes drug Avandia for six months, arguing that potential heart risks outweigh its benefits. The Saudi Food and Drug Authority (SFDA) was the first healthcare regulator to take such action. Its decision means detailing and advertising of Avandia is banned and patients on Avandia will be referred to their doctor for consultation. More>>>
03/15/2010 - The UBS (Union Bank of Switzerland) reported publicly last week that pharmaceutical giant GlaxoSmithKline PLC could end up liable for more than $6 billion in settlements and compensation for serious health complications caused by the company’s popular diabetes treatment medication Avandia. The type-2 diabetes prescription drug has been linked with severe heart problems, including heart attacks. More>>>
03/08/2010 - With its alarming rise and high number of diabetes cases, India is called the diabetes capital of the world — the sugar disease is emerging as an enormous health problem in the country. Various studies have shown that the high incidence of diabetes in India is mainly because of sedentary lifestyle, lack of physical activity, obesity, stress and consumption of diets rich in fat, sugar and calories. Among the various drugs used to treat the disease, one of it is Rosiglitazone, which is used to treat type II diabetes. However, lately there has been some dispute over the effectiveness of the medicine and its side effects. More>>>
03/08/2010 - FDA and Avandia a diabetes drug linked to 83,000 heart attacks. The FDA’s own research showed Avandia to be associated with a significant increase in heart attack risk, and yet the FDA did nothing to protect the public. The AMA admitted Avandia was dangerous. In its journal “Among patients with impaired glucose tolerance or type 2 diabetes, rosiglitazone (avandia) use for at least 12 months is associated with a significantly increase risk of myocardial infarction.” More>>>
03/02/2010 - To the chagrin of many diabetics, the medication Avandia is back in the news because of its possible link to heart problems. A Senate Finance Committee report released on Saturday says that the drug's manufacturer, GlaxoSmithKline, knew the type 2 diabetes drug had possible harmful cardiac effects several years before a 2007 New England Journal of Medicine study initially raised concerns about Avandia. GSK, for its part, says in a press release that it rejects the report's findings, adding that the committee's conclusions on the safety of Avandia are "based on analyses that are not consistent with the rigorous scientific evidence supporting the safety of the drug." More>>>
03/02/2010 - Claiming that a major drugmaker made billions of dollars on a diabetes medication that caused heart attacks and strokes, Santa Clara County on Friday filed a lawsuit charging a decade of false advertising and seeking compensation on behalf of patients and providers in California. More>>>
02/24/2010 - Good Morning America reported that a Senate report released on Monday shows that the Diabetes drug Avandia is responsible for 500 heart attacks and 300 heart failures monthly. But yet, the FDA has not removed the drug from the market. More>>>
02/24/2010 - The Food and Drug Administration (FDA) will hold a public meeting on the possible heart risks of GlaxoSmith-Kline's (GSK) diabetes treatment Avandia in July, the US regulator said yesterday, but it urged doctors to continue prescribing the drug until any new advice was issued. More>>>
02/20/2010 - The diabetes drug Avandia is linked with tens of thousands of heart attacks, and drugmaker GlaxoSmithKline knew of the risks for years but worked to keep them from the public, according to a Senate committee report released Saturday. More>>>
02/20/2010 - The blockbuster type 2 diabetes drug Avandia raises users' odds for heart attack and heart failure and should be removed from the market, according to confidential government reports. The New York Times on Saturday reported on documents from the U.S. Food and Drug Administration that find that if people now taking (rosiglitazone) Avandia switched to a similar medication, Actos, about 500 heart attacks and 300 cases of heart failure would be eliminated each month. More>>>
12/30/2009 - A local resident's lawsuit against a drug maker for not properly warning patients about how its product increases the risk of heart attacks is joining hundreds of similar lawsuits across the country. More>>>
11/19/2009 - An Arkansas man with diabetes but an otherwise clean bill of health claims his diabetes medication Avandia caused him to suffer a heart attack. Kenneth L. Bryan, 58, filed a personal injury lawsuit against GlaxosmithKline on Nov. 18 in the Texarkana Division of the Western District of Arkansas. Bryan states that around the same time he was given a clean bill of health in December 2003, he began taking the prescription drug Avandia. More>>>
10/24/2009 - Medications for Type 2 (adult-onset) diabetes are very effective at controlling blood sugar levels. You'd think, then, that the drugs would also be very effective at controlling complications of the disease related to those spikes in blood sugar: cardiovascular disease, kidney failure, blindness, nerve damage and amputation of limbs. Surprisingly, though, that has not turned out to be the case for cardiovascular events such as heart attacks and strokes. More>>>
10/23/2009 - Given the current worldwide type 2 diabetes epidemic, it’s hard for drug developers to ignore the huge potential for new, better, and safer oral drugs. The U.S. market alone has reached $5 billion annually, and the prevalence of type 2 diabetes continues to rise across the globe. More>>>
10/20/2009 - Although the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial and other trials found that rosiglitazone (Avandia, GlaxoSmithKline) increases risk of heart failure and fractures, thiazolidinediones (TZDs) are still useful for appropriate diabetic patients. More>>>
10/01/2009 - A certain class of diabetes drugs may put patients at higher risk of bone fractures, according to a study published in the online edition of the journal PLoS Medicine. More>>>
09/28/2009 - Avandia is marketed by GlaxoSmithKline for the treatment of Type 2 diabetes. Recently however, studies have shown that Avandia significantly increases the risk of heart attack and heart related deaths. More>>>
09/26/2009 - New research involving nearly 40,000 Ontario patients is questioning the use of a widely prescribed diabetes drug that an expert in drug safety says should be removed from the market. The study, published this week by the British Medical Journal, found that rosiglitazone — sold under the brand name Avandia — is associated with an increased risk of heart failure and death compared to a similar drug, pioglitazone, or Actos. More>>>
09/24/2009 - The prescription drug Avandia (rosiglitazone) causes an increase in liver problems, heart problems and bone density problems resulting in fractures. It has been linked to cases of death due to liver failure and heart failure. Patients who have taken Avandia should be aware of possible side effects and should know when to seek treatment for serious Avandia related health problems. More>>>
08/25/2009 - Canadian scientists say they have discovered rosiglitazone (Avandia) a type 2 diabetes drug, might be linked with increased risk of heart failure and death. The scientists from the University of Toronto and the Sunnybrook Health Sciences Center in Toronto, said the linkage was found among older patients, compared to a similar drug, pioglitazone (Actos). More>>>
08/23/2009 - Some Ontario researchers are calling into question the continued use of the controversial diabetes drug Avandia, saying a competing drug in the same class is as effective and less dangerous. The scientists, from Toronto's Institute for Clinical Evaluative Sciences, said people taking Actos or pioglitazone for Type 2 diabetes are 23 per cent less likely to be hospitalized for heart failure and 14 per cent less likely to die than people taking Avandia or rosiglitazone. More>>>
08/20/2009 - Toronto, ON - The risk of dying or being hospitalized with heart failure, but not of MI, is lower among older diabetic patients taking pioglitazone (Actos, Takeda Pharmaceuticals North America) than in those taking rosiglitazone (Avandia, GlaxoSmithKline), suggests a retrospective analysis based on outpatient data from across Ontario. More>>>
08/20/2009 - Scientists say doctors should stop prescribing a commonly used diabetes drug, after studies show that it is linked to higher rates of heart failure and death than a similar alternative. More>>>
08/19/20019 - New research involving nearly 40,000 Ontario patients is questioning the use of a widely prescribed diabetes drug that an expert in drug safety says should be removed from the market. The study, published this week by the British Medical Journal, found that rosiglitazone — sold under the brand name Avandia — is associated with an increased risk of heart failure and death compared to a similar drug, pioglitazone, or Actos. More>>>
08/19/2009 - GlaxoSmithKline Plc's diabetes drug Avandia is associated with an increased risk of heart failure and death among older patients compared with Takeda Actos, according to Canadian research. More>>>
08/17/2009 - Men and women who are exposed to thiazolidinediones may be at increased risk for fractures, especially with pioglitazone. A prospective cohort study examined risk for fractures in 84,339 adults (mean age, 59; 43% women) from British Columbia, Canada, who began treatment with a TZD or sulfonylurea. More>>>
07/25/2009 - The diabetes drug rosiglitazone, already under fire because it has been found to increase the risk of heart attacks, can also produce liver failure and death in some patients, researchers from the activist group Public Citizen said this week. More>>>
07/13/2009 - Poor Avandia. The GlaxoSmithKline drug failed an Alzheimer's disease trial, dashing the company's hopes of a new indication and up to $300 million in additional sales. "We saw no efficacy in this study, or the two adjunct trials," Michael Gold, Glaxo's vice president of neurosciences, told Bloomberg. More>>>
07/12/2009 - GlaxoSmithKline Plc’s diabetes drug Avandia failed to benefit patients with Alzheimer’s disease, according to a company-funded study. The findings are another setback for Avandia, once the biggest-selling drug for diabetes in the world, and raise questions about the theory that Alzheimer’s is a form of diabetes of the brain. Sales of Avandia haven’t recovered since a study linked the drug to heart attacks in May 2007. More>>>
07/07/2009 - For the 200 million diabetics worldwide, the past few years have brought some disturbing findings about risks that may be associated with certain diabetes drugs. Recent concerns that Avandia (rosiglitazone) might cause cardiovascular problems, for example, have led some experts to call for it to be pulled from the market, although it remains available today. More>>>
07/06/2009 - In a new study, GlaxoSmithKline refuses to accept the claim that its product Avandia puts patients at high risk of heart attacks; diabetologists say the final word is not yet out. More>>>
06/27/2009 - In a blow to the diabetes treatment franchise of a Deerfield drug maker, the U.S. Food and Drug Administration has asked Takeda Pharmaceuticals North America Inc. to conduct an additional heart safety trial of its experimental drug alogliptin, the company said this afternoon. More>>>
06/23/2009 - A new study may help explain how a class of diabetes drugs increases the risk of heart failure. Thiazolidinediones (TZDs) have been controversial since a 2007 analysis of Avandia (rosiglitazone), a TZD made by GlaxoSmithKline, suggested that patients taking it are at higher risk of heart attack. More>>>
06/20/2009 - The final results of the RECORD study demonstrated that overall rates of cardiovascular (CV) hospitalization and cardiovascular death - the two primary endpoints - were similar in patients taking Avandia (rosiglitazone) compared to those receiving metformin and sulfonylurea. More>>>
06/15/2009 - Be careful!Dr. Merri Pendergrass presented a study of bone fractures in close to 70,000 patients taking either rosiglitazone (Avandia) or pioglitazone (Actos) at the 2009 American Diabetes Association Scientific Sessions. Fracture risk appears to be increased by 40% for patients taking these medications. More>>>
06/13/2009 - New Orleans, LA - The largest study to date looking at whether the risk of bone fractures is increased in the setting of thiazolidinedione drugs (TZDs) suggests that fracture risk is more than 40% higher in people taking TZDs and that both men and women are vulnerable. More>>>
06/09/2009 - Doctors aren't so sure that the Avandia-exonerating safety study is as conclusive as presented at the American Diabetes Association meeting. Some physicians are calling the study "flawed." In an editorial in the Lancet--where the research was published--two doctors wrote that the study's limitations prevent any "definitive conclusions" about Avandia's effects on cardiac safety. More>>>
06/08/2009 - When Dr. Lawrence Dorr noticed patients had problems with the Durom cup, a hip-socket implant, loosening last year, he didn’t wait to act. He felt a moral obligation, he said, especially considering what he’d been through about a decade before. More>>>
05/14/2009 - After taking Avandia for five years, Frank Casteel underwent heart bypass surgery in 2007. Now Casteel is suing the drug's manufacturer alleging that the drug is not worth the risks. More>>>
05/02/2009 - Ten Utahns and two people from Oregon filed federal lawsuits Thursday against the pharmaceutical giant GlaxoSmithKline PLC alleging that the company was negligent in researching the drug Avandia, which caused them (or a spouse) to have heart attacks and subsequent health problems. More>>>
04/14/2009 - Older diabetics whose blood sugar drops to dangerously low levels have a higher risk of developing dementia, US researchers said today. The study by researchers at Kaiser Permanente in Oakland, California, suggests that aggressive blood sugar control resulting in blood sugar so low it requires a trip to the hospital may increase dementia risks in older adults with type 2 diabetes. More>>>
04/02/2009 - Treatment with the glitazone class of diabetes drugs leads to a "modest" increase in the risk of diabetic macular edema (DME)—a common complication that can lead to vision loss, reports a study in the April issue of the American Journal of Ophthalmology. More>>>
03/18/2009 - Centerview, MO: As more lawsuits are filed against the maker of Avandia alleging the drug caused irreparable harm to patients, more patients are wondering if they too have suffered an Avandia heart attack or other Avandia side effects. Meanwhile, public interest groups are encouraging patients to avoid the drug and return to older medications that do not have as many complications. More>>>
03/09/2009 - Following the discovery of heart problems with Avandia and other diabetes drugs, the FDA is requiring that drug makers establish that proposed diabetes medications do not increase the risk of cardiovascular side effects, even if the New Drug Application was filed before the new guidance was issued in December 2008. More>>>
02/12/2009- Pine Mountain Valley, GA: Dave J. (not his real name) says he is not sure how long he took Avandia for, but he says he was definitely on the medication for a while. Since he took Avandia, Dave has had a number of medical problems, including at least one massive stroke. Following his medical problems, Dave has been unable to return to any of his jobs, which included being a high school teacher, an adjunct professor and a part-time deputy with the sheriff's office. More>>>
01/21/2009- Two medicines used to treat people with diabetes can increase the risk of serious side effects, new research has found. Rosiglitazone (brand name Avandia) and pioglitazone (Actos) are medicines for type 2 diabetes. More>>>
01/12/2008- Washington -- The Food and Drug Administration is asking the manufacturers of new drugs and biologics for type 2 diabetes to be more diligent in determining if their therapies pose cardiovascular risks. More>>>
12/22/2008- Health Canada has said that the warning label information about potential Actos heart failure side effects will be strengthened to indicate that the diabetes drug should not be used in patients with pre-existing heart failure or taken together with metformin and a sulfonylurea. More>>>
12/19/2008- The Food and Drug Administration is now recommending that all new drugs developed for the treatment of type 2 diabetes show that they do not increase the risk of cardiovascular events. More>>>
12/18/2008- The major drugs for treating type II diabetes can cause bone loss and fracture, a new study has discovered. The effects can occur within just a year of taking the drugs. More>>>
12/10/2008- The widely prescribed diabetes drugs Avandia and Actos have been in the news lately because of concerns about the risk for heart failure. Now a British analysis finds Avandia and Actos double the risk of fractures in women, not in men. More>>>
12/09/2008- Long-term use of a popular class of oral diabetes drugs doubles the risk of bone fractures in women with type 2 diabetes, a new study reports. More>>>
12/04/2008- NEW DELHI: The country's drug quality regulator, Drug Controller General of India (DCGI), has asked companies selling diabetes drug rosiglitazone under various brand names to carry a warning on their labels cautioning against its potential risk to heart patients. More>>>
11/25/2008 - Older diabetics who took GlaxoSmithKline's Avandia to control their blood sugar had a higher risk of death and heart failure while on the drug than those who took Takeda Pharmaceutical's Actos, a drug in the same class, U.S. researchers said on Monday. More>>>
10/30/2008 - WASHINGTON, D.C. – The Food and Drug Administration (FDA) should immediately ban the dangerous diabetes drug Avandia because it can cause death from liver failure and has many other life-threatening risks that far outweigh its benefits, Public Citizen said in a petition filed today with the agency. More>>>
09/30/2008- Cottage Grove, OR: Robert has lived his whole life without any serious illnesses. And until recently, he considered himself to be a pretty healthy man. Unfortunately, Avandia took that away from him, made him sick, and likely caused the need for triple by-pass surgery. More>>>
09/18/2008- Canfield, OH: Dennis is just 40 years old. He was diagnosed with type 2 diabetes and was put on Avandia. But after only two weeks on the drug, Dennis experienced shortness of breath and chest pains. He had a heart attack and he thinks Avandia could have been the cause. More>>>
09/17/2008- Pacific Junction, Iowa: Donita has type 2 diabetes, and was on Avandia for over seven years. One heart attack and a triple bypass later, her life has changed forever. More>>>
09/11/2008- Donita has type 2 diabetes, and was on Avandia for over seven years. One heart attack and a triple bypass later, her life has changed forever, but she's grateful she discovered potential problems with the drug, and got off it before it was too late. More>>>
09/06/2008- The Food and Drug Administration will begin posting every three months a list of drugs whose safety is under investigation because of complaints brought to the agency's attention by drug companies, physicians and patients. More>>>
09/03/2008- Avandia has been the subject of widespread speculation that has brought drug manufacturer GlaxoSmithKline under fire for product liability claims. The drug, used to treat Type 2 diabetes, has been linked to cardiovascular deaths and serious health conditions. More>>>
09/02/2008- According to researchers at Wake Forest University, a class of oral drugs (the thiazolidinediones), which includes Avandia (rosiglitazone) and Actos (pioglitazone) may make heart failure worse in people with type 2 diabetes. More>>>
08/30/2008- Marina Del Ray, CA: Marla's mother, Vivian, died of heart failure less than a month after starting on Avandia. While Vivian was diabetic, Marla had no indication that her mother could suddenly die of heart failure. But now she wonders if Avandia played a role in her mother's death. More>>>
08/30/2008- A class action lawsuit filed this week against the makers of Avandia and the Canadian government alleges that the popular diabetes drug increases the risk of heart failure, heart attack and death for older users. More>>>
08/30/2008- In the hardest-hitting assessment of diabetes meds this year, two Wake Forest University researchers say regulators should restrict use of the glitazone class of drugs--which includes the long-suffering Avandia. More>>>
08/23/2008- Reno, NV: Lisa's father was diabetic and like many diabetics, he had difficulty regulating his blood sugar. So his doctor put him on Avandia to help. He died within 18 months of starting on the drug. More>>>
08/21/2008- Thousands of Australians who are taking the diabetes drug Avandia (rosiglitazone) have been urged by the drug's manufacturer to see their doctors following safety issues concerning the medication. More>>>
08/20/2008- MORE than 30,000 Australians taking the controversial diabetes drugs Avandia and Avandamet are being told to have their treatment reviewed after the medications were linked with heart failure and death. More>>>
08/07/2008- Avandia drug manufacturer, GlaxoSmithKline, failed to disclose several studies about Avandia to the FDA. Earlier this year, the FDA issued a warning letter to GlaxoSmithKline for postmarketing safety reporting failures. More>>>
07/28/2008- Charlotte N.C.: Vanessa is just 37 years old and diabetic. She is also someone who has survived several months on Avandia, but like many others, suffered avandia-related shortness of breath, swelling, liver problems. Luckily, she lived to tell about it. More>>>
07/28/2008- Seniors who take the popular Type 2 diabetes drug Avandia have a 60 percent higher risk of heart failure than patients who take other diabetes medications, according to a new data analysis conducted by the Institute for Clinical Evaluative Science in Toronto and published in the Journal of the American Medical Association. More>>>
07/15/2008- Charles' wife had diabetes, and she had been taking Avandia as prescribed by her doctor. But it didn't do her any good. She died at the age of 39, after having experienced a series of heart problems and resulting surgeries. More>>>
07/10/2008- The FDA is considering the possibility that required cardiovascular studies should be added to the approval process for diabetes drugs. There does seem to be a correlation between cardiovascular risks and diabetes medications. More>>>
07/08/2008- Two North Carolina patients have sued GlaxoSmithKline, claiming that the drug maker's diabetes pill, Avandia, caused their heart attacks. More>>>
07/03/2008- Clinical trial designs for diabetes drugs are not good enough at detecting cardiovascular risk with GlaxoSmithKline’s (GSK) Avandia being Exhibit A, according to experts at a Tuesday meeting of CDER’s Endocrinologic and Metabolic Drugs Advisory Committee. More>>>
07/01/2008- Drugs designed to control type 2 diabetes should be subjected to more thorough safety reviews to ensure they don't raise the risk of heart problems, U.S. Food and Drug Administration advisers said Wednesday. More>>>
06/25/2008- Sam P. is happy to no longer be taking Avandia. He says he suffered severe side effects shortly after starting the medication, although he did not realize Avandia could have been causing his health problems. More>>>
06/13/2008- Otis is a coach and teacher at a high school in Texas. He was put on Avandia for his diabetes approximately five years ago. In the fall of 2006 he was hospitalized for a heart attack More>>>
06/11/2008- The VA Diabetes Trial analysis that showed no extra cardiovascular risk from rosiglitazone (Avandia) should not be taken as conclusive, cautioned independent investigators and statisticians. More>>>
06/11/2008- In his blog, Derek Lowe considers possible reasons for GlaxoSmithKline’s major cuts in its research staff. More>>>
06/06/2008- When the American Diabetes Association convenes here June 6th for their annual meeting, there is little doubt that amongst the topics up for discussion will be the fall of Avandia. More>>>
05/30/2008- March 1st, 2007 was a day Larry remembers well because he walked into hospital while having a heart attack--his second within 24 hours. He didn’t know he was having a heart attack, and it was the last thing he expected, because he had been taking Avandia for six years. More>>>
05/16/2008- After being on Avandia for two years, Gail suffered a heart attack. When she was admitted to hospital, immediately following her heart attack, the doctors did an angiogram and found that all the arteries were blocked. More>>>
04/24/2008- GlaxoSmithKline, the world's No 2 pharmaceuticals firm, announced disappointing first-quarter results yesterday, with profits down on the same period last year, as sales of Avandia continued to fall. More>>>
04/22/2008- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the percentage of primary care physicians (PCPs) and endocrinologists who consider the cardiovascular safety of GlaxoSmithKline's Avandia to be a major concern increased more than nine-fold following publication of a meta-analysis. More>>>
04/14/2008- GlaxoSmithKline confirmed it has received a warning letter from the US Food and Drug Administration (FDA) related to reporting requirements for approved medicines. The letter follows a routine FDA inspection of GSK's reporting processes conducted last year. More>>>
04/14/2008- The two licensed glitazone anti diabetics, pioglitazone (Actos, Takeda) and rosiglitazone (Avandia, GlaxoSmithKline), now account for more than 50% of expenditure on oral hypoglycaemic drugs in the UK’s National Health Service (NHS). More>>>
04/11/2008- Every large-cap pharma seems to have at least one marketed drug that produces endless streams of woe for them. In GlaxoSmithKline's (NYSE: GSK) case, the drug in question is its type 2 diabetes compound, Avandia. More>>>
04/09/2008- GlaxoSmithKline Plc failed to report all the required studies on its diabetes drug Avandia to the Food and Drug Administration, the agency said in a warning letter released on Tuesday. More>>>
04/09/2008- GlaxoSmithKline Plc, Europe's largest drugmaker, failed to properly disclose studies of Avandia, the diabetes pill linked to potentially deadly side effects, U.S. regulators said. More>>>
04/08/2008- GlaxoSmithKline Plc, Europe's largest drugmaker, failed to properly disclose studies of the diabetes pill Avandia after it was linked to potentially deadly side effects, U.S. regulators said. More>>>
04/08/2008- GlaxoSmithKline Plc failed to report some post-marketing data on its diabetes drug Avandia, the U.S. Food and Drug Administration said in a warning to the company released on Tuesday. More>>>
04/08/2008- S GlaxoSmithKline (NYSE:GSK) Plc., said it has received a warning letter from the Food and Drug Administration, which points to failures in periodic reports to the agency about its troubled Avandia diabetes product. More>>>
04/07/2008- SCOTTISH doctors have said there is "no defense" for the use of a widely prescribed diabetes drug after warnings that it should not be used in patients with heart problems, The Scotsman can reveal.The consultants, who work in the NHS Greater Glasgow and Clyde area, recommend no new patients are given Avandia – also known as rosiglitazone.More>>>
03/30/2008 Early in August 2006, Vivian's mother went to the hospital in Edmonton to have some cancer tests done. However, when she arrived the doctors noticed that the left side of her body was swollen. They took her vital signs and noticed her heart was racing. She was admitted to hospital that day, and on further testing the doctors discovered that her heart was enlarged as well. Over the next few days the doctors were unable to bring Vivian's mother's heart rate under control and she died.More>>>
03/29/2008 The diabetes landscape is a tad riskier for drugs in development that have a safety glitch or two, and the bottom line could mean higher costs.
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03/16/2008 - Donald McEwen was driving on I-480 when he saw an ad on the back of a bus recruiting people for a study on diabetes. More>>>
03/04/2008 - The government's watchdog agency is investigating whether the Food and Drug Administration's drug-review process cleared two blockbuster medications without sufficient proof of their safety or effectiveness. More>>>
03/04/2008 - In the wake of the controversy over the diabetes drug Avandia, the U.S. Food and Drug Administration is considering tougher standards for how and when diabetes drugs will be tested for risks to the heart.
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02/25/2008 - A flood of drug safety warnings from the Food and Drug Administration may have physicians and patients suffocating from information saturation. More>>>
02/19/2008 — A series of surprising findings about some of the most widely accepted assumptions in medicine has renewed debate about how aggressively doctors use drugs to prevent and treat some of the nation's leading health problems. More>>>
02/14/2008 - An Oklahoma man is suing drugmaker GlaxoSmithKline in federal court, claiming its popular diabetes pill gave him heart problems that required bypass surgery. More>>>
02/04/2008 - So much for confidential peer review. Last May, a controversial paper in the New England Journal of Medicine (NEJM) reported that a popular diabetes drug—rosiglitazone, sold under the brand name Avandia—substantially hikes a user's risk of heart attack. More>>>
01/31/2008 - Weeks before an influential article was published last year in the New England Journal of Medicine linking the diabetes drug Avandia to a risk of heart attacks, a physician helping peer-review the article broke the Journal's confidentiality rules and leaked a copy to the drug's maker, GlaxoSmithKline PLC. More>>>
01/31/2008 - A peer reviewer for the Waltham-based New England Journal of Medicine leaked a negative article about a diabetes drug to its manufacturer more that two weeks before the study appeared, another major scientific journal reports today. More>>>
01/30/2008 - A peer reviewer for The New England Journal of Medicine (NEJM ) broke confidentiality and leaked a damaging report about the blockbuster diabetes drug Avandia to the drug's manufacturer weeks ahead of publication, Nature has learned. More>>>
01/30/2008 - The wall between a prestigious medical journal and a major drug company may have been shattered.
The scientific journal Nature reported today that a peer-reviewer for The New England Journal of Medicine leaked key study results on GlaxoSmithKline's diabetes drug Avandia to the company weeks before they were published. More>>>
01/25/2008 - Controversies about cholesterol drug Vytorin and diabetes drug Avandia are reigniting debate over what evidence the Food and Drug Administration requires to approve drugs -- and may generate pressure on the agency to raise its bar. More>>>
01/24/2008 - GlaxoSmithKline PLC said is to revise the labeling on its Avandia diabetes product to include additional warnings that the product may be associated with an increased risk of heart attacks, after a decision by the European regulator (CHMP) today. More>>>
01/21/2008 - Every year the Harvard Health Letter chooses what it considers to be the top 10 health stories of the year. During 2007, there weren't many instant breakthroughs that would qualify as scientific discoveries. Instead, we saw a slow, steady accumulation of data from multiple studies and clinical trials that finally reached a critical mass that could be considered an important health story. More>>>
01/17/2008 - I'm often asked, "How can I live to be 100 years old?" My answer is simple, "Just say no to prescription drugs and learn how to control insulin and blood sugar." More>>>
01/15/2008 - A professional doctors' group has petitioned the Food and Drug Administration to require that Avandia's warning label include a statement that a low-fat vegan diet is a safer, more effective approach to lowering blood sugar levels than the drug itself. More>>>
01/09/2008 - According to a November 2007 report by the Senate Finance Committee, an analysis by FDA scientists presented at a July 30, 2007, safety panel meeting estimates that Avandia has caused approximately 83,000 excess heart attacks since coming on the market. More>>>
01/08/2008 - Older patients who took Avandia had a higher risk of heart attacks, congestive heart failure and death than those on other diabetes pills, according to a study of nearly 160,000 Canadians. More>>>
01/03/2008 - An analyst with Merrill Lynch believes the controversy over cardiovascular risks posed by GlaxoSmithKline’s Avandia may have caused diabetics and their doctors to avoid treatment altogether. More>>>
12/24/2007 - Smokers taking the Pfizer drug Chantix to help them quit might have missed a Food and Drug Administration report in late November that the drug has been linked to drowsiness and suicidal thoughts. That's because while a drugmaker may issue a press release and the FDA an advisory when a drug is recalled or has a warning added, neither is obliged to directly notify consumers taking the drug, says Areta Kupchyk, a food and drug lawyer with the D.C. law firm Reed Smith. More>>>
12/23/2007 - Persistent questions about the safety of both prescription and over-the-counter drugs, a menacing microbe spreading throughout the U.S. and a globe-trotting TB patient garnered headlines this past year. More>>>
12/12/2007 - Older diabetes patients treated with Takeda Pharmaceutical North American Inc.'s Actos and GlaxoSmithKline PLC's Avandia had a "significant" increased risk of heart attack, congestive heart failure and death compared with those taking a more established treatment, according to a study in this week's Journal of the American Medical Association. More>>>
12/12/2007 - Older patients who took Avandia had a higher risk of heart attacks, congestive heart failure and death than those on other diabetes pills, according to a study of nearly 160,000 Canadians out Wednesday. More>>>
12/12/2007 - An independent analysis of thousands of older people with diabetes found that those treated with the widely used drug Avandia had significantly elevated risks of heart attack and death.
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12/12/2007 - Canadian researchers furnished the strongest evidence to date linking the popular diabetes drug Avandia to an increased risk of heart attack in a scientific study released yesterday. More>>>
12/12/2007 - It must feel like Groundhog Day for GlaxoSmithKline as another analysis has been revealed which claims that Avandia, as well as Takeda’s Actos, is associated with an increased risk of congestive heart failure, heart attack and death compared with other oral diabetes drugs in older patients. More>>>
12/11/2007 - Older people taking GlaxoSmithKline Plc's Avandia and Takeda Pharmaceutical Co.'s Actos had a higher risk of heart attacks, failure and death than those taking other diabetes pills, a study by Canadian researchers showed. More>>>
12/11/2007 - Older patients treated with diabetes drug Avandia, sold by GlaxoSmithKline PLC, and Actos, made by Takeda Pharmaceutical Co. Ltd., have a significantly increased risk of heart attack, congestive heart failure and death compared to the other diabetes treatments More>>>
12/11/2007 - The popular diabetes medication Avandia is under scrutiny again. A new Canadian study finds that the drug, along with others like it, increases the risk of heart failure, heart attacks and death in older adults. More>>>
12/11/2007 - Another study has found evidence that certain diabetes drugs, especially GlaxoSmithKline's Avandia, can cause heart attacks and death, but the company said the findings did not make scientific sense.
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12/08/2007 - Avandia places patients at a high risk of bone fractures and osteoporosis by affecting the way bone cells are replenished in the body. More>>>
12/07/2007 - GlaxoSmithKline’s controversial type 2 diabetes drug Avandia is back in the headlines following the news that two major pharmacy benefit managers in the USA are pulling the treatment from their formularies. More>>>
12/06/2007 - Slightly less than half of all patients who have discontinued the use of GlaxoSmithKline’s anti-diabetes drug Avandia over cardiac safety concerns were switched to Takeda Pharmaceuticals’ Actos, according to a healthcare information company. More>>>
12/06/2007 - HealthTrans Pharmacy and Therapeutics (P&T) Committee recommended removal of Avandia(R) (rosiglitazone) from its value-based formulary effective Jan. 1 due to concerns surfacing in clinical data in recent months. More>>>
12/5/2007 - Prescribing information about the diabetes drug rosi-glitazone (Avandia) is being updated to include a stronger warning about the risk of heart attack. More>>>
12/04/2007 - Drug developers are just beginning to grapple with recent FDA oversight reforms, but already industry and consumer advocates disagree on how well the overhaul will be able to prevent future drug safety scandals. More>>>
11/30/2007- The FDA should overhaul its approval process for new anti diabetics, argues Robert Misbin, from the FDA’s Division of Endocrinology and Metabolism and the medical officer who initially reviewed Avandia’s (rosiglitazone) application. More>>>
11/29/2007 - Doctors are taking a variety of approaches in response to Avandia's potential cardiac risks, with most opting either to switch diabetes patients to replacement drugs or to change dosage. More>>>
11/27/2007- Late yesterday, a bullet crossed the Dow Jones newswire saying, "FDA Warns GlaxoSmithKline on Breast-Cancer Drug Promotion." Almost immediately, my producer and I got a call from the CNBC staffer who was manning what we call our "Alerts Desk" asking us if we'd seen the news and if we could provide any context. We started digging, checking out the Glaxo and FDA web sites and placing calls to our GSK and FDA contacts. More>>>
11/27/2007- European and U.S. diabetologists called on Tuesday for greater caution in prescribing oral diabetes pills like GlaxoSmithKline Plc's Avandia, which has been linked to increased heart attack risk. More>>>
11/27/2007- A U.S. Food and Drug Administration official called for higher safety standards in approving diabetes drugs in the aftermath of fears about links between a top diabetes drug and heart attack risk. More>>>
11/27/2007- Two senior members of the Senate are seeking an interview with Tadataka Yamada, the former chairman of R&D for GlaxoSmithKline (GSK), to discuss his role in the alleged intimidation of John Buse, a professor at the University of North Carolina at Chapel Hill who raised concerns in 1999 about cardiovascular risks associated with Avandia. More>>>
11/26/2007- Six out of every 10 (61%) of the 408 respondents to a MedPage Today poll said the FDA should have been tougher when it ordered that a myocardial infarction warning be added to the black box warning for heart failure on the rosiglitazone (Avandia) label. More>>>
11/24/2007- When it comes to ensuring that prescription drugs are safe, the buck is supposed to stop with the U.S. Food and Drug Administration. More>>>
11/22/2007 - Avandia was approved in 1999. In recent years, some studies, including one last month, linked it to increased risk of heart attacks. The FDA voted this summer to beef up warnings on its label but keep it on the market. More>>>
11/20/2007- It didn't take long for Japan's Takeda Pharmaceuticals, which trades on the Tokyo exchange, to try to capitalize on the new safety warning for GlaxoSmithKline's diabetes drug Avandia. More>>>
11/20/2007- Two high-ranking senators placed a report in the Congressional Record detailing how GlaxoSmithKline (GSK) employees allegedly intimidated a scientist who raised concerns over the company’s Type 2 diabetes drug Avandia. More>>>
11/19/2007- GlaxoSmithKline announced that it is implementing changes to the US product label for Avandia® (rosiglitazone maleate), based on an extensive and thorough review by the FDA of myocardial ischemia data on Avandia, the most widely studied oral anti diabetic medicine available. More>>>
11/18/2007- The GlaxoSmithKline diabetes drug Avandia will have a new black box warning added to their product. The Black Box warning is the most severe warning a drug can have, and this is the second warning for Avandia. More>>>
11/17/2007- The Wall Street Journal reported Friday that Takeda Pharmaceutical Co. a company based in Japan planned to launch a massive ad campaign to remind patients that unlike Avandia its diabetes drug Actos does not increase risk of heart attack. More>>>
11/17/2007- Over a period of several years, drug maker GlaxoSmithKline PLC was so concerned about a prominent physician's negative views of its diabetes drug that it engaged in a concerted effort to intimidate him and stifle his opinion, a report by the U.S. Senate Finance Committee found. More>>>
11/16/2007- Here is the text of a statement issued by GlaxoSmithKline. More>>>
11/15/2007- GlaxoSmithKline PLC's Avandia, the world's best-selling diabetes drug last year, will carry US regulators' strongest warning on the risk of heart attacks. More>>>
11/15/2007- Avandia, the world's best-selling diabetes drug last year, will carry the Food and Drug Administration's strongest warning on the possible risk of heart attacks, the agency announced yesterday. More>>>
11/15/2007- After a fierce internal debate, federal drug officials have decided to allow Avandia, the controversial diabetes medicine, to remain on the market but insisted that a new warning about its heart risks be placed on its label. More>>>
11/14/2007- The FDA announced, in a press release November 14th, that the diabetes drug rosiglitazone (Avandia) will receive new information in the black box warning that is already in place on the drug's label. The updated information will include warnings that rosiglitazone may cause heart attacks. More>>>
11/14/2007- FDA informed healthcare professionals of new information added to the existing boxed warning in Avandia's prescribing information about potential increased risk for heart attacks. More>>>
11/14/2007- The U.S. Food and Drug Administration announced today that the manufacturer of Avandia (rosiglitazone),a drug used to treat type 2 diabetes, has agreed to add new information to the existing boxed warning in the drug’s labeling about potential increased risk for heart attacks. More>>>
11/14/2007- GlaxoSmithKline said Wednesday it is implementing changes to the U.S. product label for Avandia, based on a Food and Drug Administation review of myocardial ischemia data onthe diabetes drug. More>>>
11/14/2007- The Food and Drug Administration Wednesday toughened warnings on GlaxoSmithKline PLC's diabetes drug Avandia, saying the product was linked to a potential increase in the risk of heart attacks. More>>>
11/14/2007- The U.S. Food and Drug Administration issued the following safety alert on GlaxoSmithKline Plc'sdiabetes drug Avandia on Wednesday. More>>>
11/14/2007- GlaxoSmithKline Plc's diabetes pill Avandia will carry U.S. regulators' strongest warning on the risk of heart attacks. More>>>
11/14/2007- The U.S. Food and Drug Administration will announce its decision on GlaxoSmithKline Plc's diabetes drug Avandia within days, its deputy commissioner said on Tuesday. More>>>
11/06/2007- GlaxoSmithKline Inc., in consultation with Health Canada, has sent out a letter to health care professionals to inform them of important new restrictions on the treatment of type 2 diabetes mellitus with the rosiglitazone-containing products: Avandia(R) (rosiglitazone) More>>>
11/01/2007- They scuttle product launches and send company stocks through the floor. They steal precious years from patents and require pricey new trials. They have the entire drug industry on edge, from struggling one-hit biotech's to struggling large-cap pharma's.More>>>
10/31/2007- America's 20 million-plus diabetics mean dollar signs for drug companies that sell a slew of new products, including a successful drug based on the saliva of a Gila monster, and a failed inhalation device that's been compared to a "bong." More>>>
10/31/2007- Senate Finance Committee Ranking Member Chuck Grassley (R-Iowa) is questioning the FDA about an alleged vote by its Drug Safety Oversight Board (DSOB) to keep GlaxoSmithKline’s (GSK) Type 2 diabetes drug Avandia on the market. More>>>
10/30/2007- The U.S. Department of Veterans Affairs has deleted rosiglitazone (Avandia), the diabetes drug that has been linked to increased risk of myocardial infarction and heart failure, from its formulary. More>>>
10/29/2007- A senior Republican lawmaker asked the U.S. Food and Drug Administration to confirm that an internal FDA group privately voted to keep the troubled diabetes drug Avandia on the market by a one-vote margin, according to a letter made public on Monday. More>>>
10/29/2007- Last week, the Glaxo diabetes pill was in the news again because the FDA is now considering a second Black Box warning for heart attacks, in addition to an earlier warning for congestive heart failure. More>>>
10/24/2007- U.S. Food and Drug Administration officials are pushing for a "black box" warning of the risk of heart attack on GlaxoSmithKline Plc's diabetes drug Avandia More>>>
10/24/2007- The Food and Drug Administration wants GlaxoSmithKline PLC to add the strongest form of safety warning about heart-attack risk to the label of its diabetes drug Avandia
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10/22/2007- The Department of Veterans Affairs (VA) has removed GlaxoSmithKline’s (GSK) Type 2 diabetes drug Avandia from its national formulary and is restricting the drug’s availability.
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10/19/2007- GlaxoSmithKline is expected to unveil a £100 million slide in sales next week, led by flagging demand for Avandia, the diabetes drug which has been at the center of a safety scare over its heart risks. More>>>
10/18/2007- The U.S. Department of Veterans Affairs has decided to "severely limit" the use of GlaxoSmithKline Plc's diabetes drug Avandia over safety concerns, the New York Times reported on Wednesday. More>>>
10/18/2007- Dr. Steven Nissen is sticking to his guns.
His latest target has been Avandia, the diabetes drug by GlaxoSmithKline: his analysis of 42 studies concluded it raises the risk of heart attack by 43 percent. More>>>
10/18/2007- GlaxoSmithKline PLC's Avandia diabetes medicine is to be relabeled with a stronger warning about heart attack risks after European authorities met to discuss all products in the diabetes class. More>>>
10/16/2007- An explosion of new research is vastly changing scientists’ understanding of diabetes and giving new clues about how to attack it. More>>>
10/5/2007- It is a statistic that is showing an alarming trend.The number of serious adverse drug events reported to the U.S. Food and Drug Administration has more than doubled between 1998 and 2005, as did deaths linked to such events, reports the Sept. 10 issue of Archives of Internal Medicine. More>>>
10/5/2007- The September 2007 Journal of the American Medical Association (JAMA) has published two new studies, one a meta-analysis of Avandia (rosiglitazone) and the other a meta-analysis of Actos (pioglitazone). More>>>
10/1/2007- A further pall has been cast over Avandia, a drug for Type 2 diabetes. A new study has found that long-term use of the pharmaceutical increases heart attack risk by more than 40 percent and doubles the chance of heart failure. More>>>
09/27/2007- The diabetes drugs Actos and Avandia raise the risk of heart failure but do not increase the risk of heart-related death, U.S. researchers said on Thursday, confirming earlier findings. More>>>
09/20/2007- People with diabetes face hazards aplenty, among them twice the normal risk of heart disease and stroke and up to four times the chance of a fatal heart-related event. More>>>
9/17/2007- A consumer watchdog group stands by its belief that Avandia, the embattled type 2 diabetes drug, should be removed from the market, a demand the group's leadership says was fortified last week by additional research.More>>>
9/12/2007- Avandia, GlaxoSmithKline's (GSK) controversial diabetes drug, has again come under fire after more research was released claiming that the treatment increases the risk of heart attacks. More>>>
9/12/2007- The diabetes drug Actos cuts the risk of heart attack, stroke and death, but raises the risk of heart failure, according to one study published on Tuesday, while a second confirmed disputed findings that rival Avandia raises heart risks. More>>>
9/12/2007- Two studies and an editorial today should lead the Food and Drug Administration to pull the diabetes pill Avandia off the market, the authors say. More>>>
9/12/2007- Scientists have discovered long-term use of the popular diabetes drug Avandia can increase a person's risk of heart attack. More>>>
9/10/2007 - The FDA recently announced that it will require manufacturers of certain diabetes drugs to add a stronger warning to their labeling about the risk of heart failure. More>>>
9/10/2007- A prominent New England researcher has rekindled a debate about the standards the Food and Drug Administration uses to speed approval of life-saving drugs, arguing that federal officials should insist on more rigorous proof that the drugs save lives and improve patients' health. More>>>
9/6/2007- Experiments in mice suggest that the type 2 diabetes drugs rosiglitazone (Avandia) and pioglitazone (Actos) increase uptake of both glucose and triglycerides in cardiac tissue, causing or exacerbating heart failure.
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8/27/2007- Testimony of Sidney Wolfe M.D., Elizabeth Barbehenn Ph.D. and Ben Wolpaw, Health Research Group of Public Citizen. I will focus on the fourth question to the committee: Does the overall risk-benefit profile of rosiglitazone (Avandia) support its continued marketing in the US? More>>>
8/25/2007 - The maker of Avandia warns that this drug can cause fluid retention and congestive heart failure. Patients are cautioned that swelling, rapid weight gain, breathing problems or unusual tiredness may be serious and deserve immediate medical attention. More>>>
8/23/2007 - Avandia attitudes:
Only nine percent of respondents said they would continue prescribing it without reservations, and one in four said it should be taken off the market. More>>>
8/15/2007- US regulators have approved new “black box” warning labels for GlaxoSmithKline's controversial diabetes drug Avandia. More>>>
8/15/2007- It might not be a skull and cross bones, but a "black box" warning is not the type of label that most pharmaceutical companies like to see on any of their products. More>>>
8/15/2007- The Food and Drug Administration said Tuesday that GlaxoSmithKline has agreed to use a so-called "black box" warning regarding the risk of heart failure for its Avandia type 2 diabetes drug. More>>>
8/15/2007- The diabetes drugs Avandia and Actos will be labeled with severe warnings about a risk of heart failure to some patients, health officials said Tuesday. More>>>
08/14/2007 - After a review of post marketing adverse event reports, FDA determined that an updated label with a boxed warning on the risks of heart failure was needed for the entire thiazolidinedione class of antidiabetic drugs. This class includes Avandia. More>>>
8/13/2007- GlaxoSmithKline is considering cutting its pharmaceutical sales force in response to the collapse in sales of its diabetes drug Avandia. More>>>
08/13/2007- The controversial diabetes drug Avandia has been a problem for its maker, GlaxoSmithKline. Research has concluded the drug carries the risk of heart attack. More>>>
08/12/2007- A pair of votes July 30 by a Food and Drug Administration advisory panel offered mixed recommendations for the agency and signaled caution for physicians who prescribe Avandia. More>>>
08/10/2007- The Saudi Ministry of Health is to discuss the results of studies on Avandia, an anti-diabetes medicine also known as rosiglitazone, next week to see whether the medicine is safe for use. More>>>
08/08/2007- The debate over the heart-attack risks posed by the type 2 diabetes drug Avandia has taken another twist, with a new study questioning the results of the research that kick-started the controversy. More>>>
08/08/2007-
While Avandia may still be viable for some patients in spite of increased risks for heart attack, stroke and kidney failure, most doctors are advocating a switch away from Avandia
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08/06/2007 - Amid the allegations of increased heart attack risk with Avandia, a popular anti-diabetes drug, the general cost of prescription drugs and the horror stories of fake medicines from overseas, you may think about missing a dose. More>>>
08/06/2007- GlaxoSmithKline today welcomed the nearly unanimous recommendation of an U.S. Food and Drug Administration’s (FDA) advisory committee to support Avandia’s continued availability to patients in the US. More>>>
08/04/2007- They're just dropping like Chinese imports--prescription drugs that turn out to be deadly after FDA approval. More>>>
08/02/2007- "I logically can't find any way to leave this drug on the market," states Arthur Levin, director of the Center for Medical Consumers in New York. The drug Levin refers to is Avandia. More>>>
08/02/2007- An FDA advisory committee has recommended that GlaxoSmithKline's diabetes treatment Avandia should remain available on the US market, albeit with stronger health warnings. More>>>
08/01/2007- GlaxoSmithKline’s Avandia (rosiglitazone) appears likely to get stricter labeling, per the recommendation of an FDA advisory panel. More>>>
08/01/2007- It might offer some advantages for you, but some doctors said there are other medications that will treat diabetes without the possible side affects of Avandia, and they recommend patients consider switching and going off Avandia right away. More>>>
07/31/2007- Popular Drug Associated With Risks to Multiple Organ Systems Has No Benefit Over Older, Safer Type 2 Diabetes Drugs. More>>>
07/31/2007 -
Most Colorado diabetics who were using Avandia, a drug that controls blood-sugar levels, were taken off it two months ago when a scientific article pointed to increased risks of heart problems. More>>>
07/30/2007 - One million Americans with Type-2 Diabetes take Avandia to control blood sugar; however studies show it can increase the risk of heart attacks by 43 percent. More>>>
07/30/2007- The U.S. government is looking into safety concerns about the diabetes treatment drug Avandia, with a top safety scientist urging that it be pulled from the market. More>>>
7/30/2007 - The widely used diabetes drug Avandia (rosiglitazone) provides no unique short term benefits to type 2 diabetics and should be withdrawn from the U.S. market because of heart risks, a FDA scientist said on July 30th. More>>>
7/30/2007 -
One of the US FDA's scientists has called for GlaxoSmithKline's diabetes drug Avandia to pulled off the market because of the risk of heart disease. More>>>
7/27/2007 -
The widely used diabetes drug Avandia increases the chance of serious heart problems, including a 30% to 40% higher risk of myocardial ischemia. More>>>
7/27/2007 - According to documents released on the FDA's website Thursday, FDA officials are concerned that users of Avandia may face an increased risk of heart attack. More>>>
7/27/2007 - The Times claimed that diabetics “face an increased risk of heart attacks while those who take Actos, a similar drug, do not..." More>>>
7/27/2007 - Neil Pender's father passed away five years ago from a heart attack and he is angry. "My father started taking Avandia shortly after it was approved in 1999 but we didn't hear about the dangers of this drug until June of this year" More>>>
7/27/2007 - Two of the most commonly used drugs for diabetes, which were taken by hundreds of thousands of mostly overweight people in the UK last year, are causing widespread heart failure. More>>>
7/27/2007 - Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, is one of the most distinguished physicians in the world. He has developed fame and notoriety due to his challenging of the safety of certain drugs. More>>>
7/27/2007 - A class of drugs commonly used to treat type 2 diabetes may double the risk of heart failure, according to a new analysis by researchers at Wake Forest University School of Medicine and colleagues. More>>>
7/27/2007 - A class of drugs commonly used to treat diabetes doubles the risk of heart failure, according to a new study. More>>>
7/25/2007 - On Monday, July 30, a panel of academic scientists will meet to advise the U.S. Food and Drug Administration as to what, exactly, the regulator should do about Avandia, the best-selling diabetes drug in the world. More>>>
7/24/2007 - GlaxoSmithKline is expected by analysts to report a fall in revenue of more than £100 million after a collapse in sales of Avandia, its diabetes medicine, which has been linked to an increased risk of heart attacks and strokes. More>>>
7/22/2007 - Back in the ’60s, when University of Michigan students were holding protests over civil rights and the Vietnam War, an undergraduate named Steven E. Nissen was at the center of the political dissent. More>>>
7/20/2007 - Little evidence supports using rosiglitazone (Avandia) to improve the quality or length of life among adults with diabetes. More>>>
7/19/2007 - GlaxoSmithKline Plc's Avandia, tainted by reports linking the drug to increased heart attack risks More>>>
7/18/2007 - A review of research reveals there is not much evidence to support using rosiglitazone (Avandia), a medication previously prescribed to lower blood glucose levels in adults with type two diabetes. More>>>
7/17/2007 -
Though the FDA has yet to advise on the cardiovascular safety of GlaxoSmithKline's Avandia type 2 diabetes drug... Internists said they will switch more than half their type 2 diabetes patients currently on Avandia to another therapy. More>>>
7/17/2007 - Little evidence supports using rosiglitazone (Avandia) to improve the quality or length of life among adults with diabetes, according to a systematic review of data by German researchers More>>>
7/16/2007 - Most type 2 diabetes drugs are equally effective for lowering blood sugar, but the generic drug metformin has fewer side effects than several newer, pricier medications More>>>
07/16/2007 - An executive of the company that makes the diabetes drug Avandia said a researcher who was among the first to link it to heart problems. More >>>
05/22/2007 - A widely prescribed drug to treat Type 2 diabetes substantially increases the risk of heart attacks and death from cardiovascular disease, according to a study released today.
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02/22/2007 - Women taking the diabetes drugs Avandia, Avandamet, or Avandaryl may be more likely to fracture their bones than those using other diabetes drugs. More >>>
11/15/2006 - A Food and Drug Administration panel is set to meet Thursday to discuss the safety review of 16 drugs. More >>>
If you or a loved one have experienced an Avandia heart attack, or Avandia stroke, Avandia congestive heart failure, Avandia cardiovascular disease or if you have lost a loved one to an Avandia death you may be entitled to compensation. Contact the Avandia lawyers of Ennis & Ennis, P.A. today about an Avandia lawsuit. Call us toll free for a free, confidential case evaluation or fill out our online Avandia case evaluation form.