Public Citizen Agency asked for heart failure to be noted on Avandia labels.
*** Avandia® Labeling Update 2/4/11: The FDA has notified healthcare professionals and patients that information on the cardiovascular risks (including heart attack) of Avandia (rosiglitazone) has been added to the physician labeling and patient Medication Guide. Additionally, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:
- In patients already being treated with these medicines
- In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).
What’s the problem?
Consumer advocacy group Public Citizen released a memo a day after researchers announced Avandia increases the risk of cardiovascular-related death by 64 percent and the risk of heart attack and related heart injury by 43 percent.
In the memo, Public Citizen stated that the U.S. health authorities were well aware of heart risks linked to Avandia as far back as 2002. That year, FDA scientists called for reports of congestive heart failure to be noted on the label of Avandia.
The head of Public Citizen’s Health Research Group Dr. Sidney Wolfe stated that the 2002 memo illustrated that the FDA failed to take its own staff scientists seriously: “As a result, millions of people, to the detriment of their health, are prescribed drugs whose risks are dangerously understated, instead of being prescribed safer, equally, or more effective alternative drugs.”
Dr. Wolfe wrote a letter to FDA Commissioner Andrew von Eschenbach asking the agency to issue a black box warning for Avandia, or to even ban the drug altogether. He wrote, “There continues to be no mention of the large and increasing number of post-marketing reports of heart failure, which was the explicit recommendation of the 2002 internal memo.”