Avandia Side Effects

Avandia was first approved by the FDA in 1999 as a supplementary treatment for type 2 diabetes that was to be used in conjunction with diet and exercise and if necessary other medications to help control blood sugar levels. In the following year the Public Citizen consumer advocacy group asked the FDA to reconsider how the description of the side effects of Avandia were written as reports were already coming in of the increased risk of heart failure and other major medical problems. Avandia was only one of the glitazones the group wanted to have relabeled to show the increased risks. The group felt that Avandia and the two other drugs Rezulin and Actos that were used to help those with type 2 diabetes to control their blood sugar levels had very inadequate labeling of the medication regarding their side effects.

Avandia like the other two had warnings that did not mention overall safety and efficacy information to allow comparison to drugs already on the market, let alone the amounts of blood sugar level depletion when switched from other diabetic drugs to Avandia. Other side effects of Avandia such as the effects it had on the heart, liver toxicity, edema, low blood pressure, progesterone level issues, anemia, weight gain and elevated lipid levels were not included on any of the warning labels. Unlike Rezulin which had already been banned in the UK by 2000 for the damage it caused to the liver, Avandia was allowed to continue into the US and then world market. Rezulin has since been recalled and thousands of lawsuits filed due to the high instances of liver transplants and death that it has caused. In recent years GlaxoSmithKline have invested $3 million to study the long term side effects of Avandia. This is expected to take several years as the scope of the clinical trials will have to cover a much broader spectrum of patients compared to the studies required for FDA approval of a new drug.

In many cases FDA approval studies do include large numbers of people, but can still fail to cover a broad enough spectrum of people to show how the new medication can affect certain groups of the world's population. These new studies are designed to cover a much better selection of the population. In fact in the last few years it has become increasingly difficult for drug manufacturers to find enough people to volunteer as test subjects to test drugs like Avandia for side effects. This can drastically slow down the speed at which new medications can be brought to market, whether or not they side effects or are a desperately needed medication. In some cases it can lead to a medication hitting the market before it is truly ready to be used. If you or someone you know has been adversely affected by the side effects of Avandia you should seek legal counsel. Contact the Avandia lawyers of Ennis & Ennis, P.A. for a free, confidential, legal consultation. Nationwide: 1-800-856-6405.