The FDA says safety data from controlled clinical trials has shown a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia. The study shows that Avandia increases heart attack risk by 43 percent and increases risk of death from heart disease by 64 percent.
According to Web MD news, the overall risk is however relatively small. The research found that among the 15,560 Avandia patients there were 86 heart attacks and 39 deaths, compared with 72 heart attacks and 22 deaths among the 12,283 patients not taking Avandia.
The federal agency has reportedly recommended the users of Avandia to should talk to a doctor about the new information. This is a must for those known to have underlying heart disease or who are at high risk of heart attack.
The FDA also added that there is an inherent risk associated with switching diabetic patients from one treatment to another and hence patients should not discontinue or alter the pill's use without the doctor's consultation.
The report will be published in The New England Journal of Medicine. Avandia is manufactured by GlaxoSmithKline of Research Triangle Park, North Carolina. Avandia is sold by itself and, as Avandamet and Avandaryl, in pills that combine Avandia with other diabetes medications.
