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.
Takeda's move was triggered by a recent decision of the Food and Drug Administration to require GlaxoSmithKline PLC to add more warning information in the black boxed warning label for its diabetes drug Avandia to alert patients of the potential increased risk of heart attack.
Both Actos and Avandia are used to help type 2 diabetes patients. Takeda feared that the FDA's action may make patients to believe that Actos could also boost the same risk, which is in fact not the case.
According to the WSJ news report, Takeda intended to run full-page ads in about 60 newspapers and several news magazines in the United States to tell patients "If you have type 2 diabetes, Actos has been shown to lower blood sugar without increasing your risk of having a heart attack or stroke."
Diabetes patients who ever care about the drug they are taking may have noticed an study conducted by a distinguished heart physician that shows use of Avandia has been associated with increased risk of heart attack while Actos does not increase the risk.
Steven Nissen, a prominent heart specialist and chief of cardiovascular medicine at the Cleveland Clinic, one of the best heart clinics in the world, analyzed data from 42 clinical trials of Avandia and he found that Avandia patients were 43 percent more likely to have a heart attack or be hospitalized for blocked coronary arteries than others in the studies.
His findings were reported in the New England Journal, a prestigious medical journal in the world. But Glaxo based in the United Kingdom claimed that Dr. Nissen's study was flawed and has maintained that Avandia is safe for the heart like other diabetes drugs.
The heart risk potentially caused by Avandia is so great that Dr. David Graham of the FDA's Office of Surveillance and Epidemiology early told panelists who have the power to determine the fate of Avandia that the Glaxo's diabetes drug should come off the market, according to USA Today.
Dr. Graham also said Actos does not increase heart risk like Avandia and suggested that there is no reason for the Glaxo's drug to stay on the market.