Avandia linked to Heart attacks and Heart Failure

Avandia is prescribed to treat diabetes and has been linked to heart attacks.The popular diabetes drug AVANDIA (rosiglitazone) has now been linked to heart attacks and heart related deaths. A recent study published in the May 2007 New England Journal of Medicine shows that patients who took this widely prescribed drug for type 2 diabetes developed myocardial infarctions or heart attacks as well as increased risk of death from other heart related ailments. This has resulted in an Alert from the FDA on May 22, 2007 informing health care professionals of Avandia related safety issues. The drug, which is manufactured by GlaxoSmithKline, came on the market in 1999, and boasts more that 11.3 million prescriptions to date, with estimated retail costs to consumers over $1.6 billion. Post marketing reports in the eight years since the drug’s approval have reflected heart risks and related deaths for patients taking AVANDIA, although AVANDIA has not been shown to benefit the health of diabetes patients taking this drug in a clinically meaningful way. Alarmingly, Glaxo, by mid 2006, had apparently advised the FDA of its own analyses of risks of AVANDIA related cardiac events, essentially mirroring the NEJM article, which was published one year later, but down played the significance of these findings to the FDA leaving both patients and their physicians in the dark about these disturbing findings. There are now well over 600 cases, which have been reported to the FDA for heart failure issues alone. The drug is also linked to weight gain, liver failure and liver damage, visual impairment and most recently increased risk of upper arm, hand and foot fractures in women taking the drug. Read the complete 2007 Safety Summary regarding this issues at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Avandia

Avandia in the News

FDA Concerned about Avandia Risks



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