Two studies released last month report that Avandia is unsafe, heating up controversy about a drug linked to an increased risk of heart attack and heart failure.
*** 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?
Two new studies presented in the Journal of the American Medical Association (JAMA) and its sister publication, the Archives of Internal Medicine, allege the diabetes drug Avandia is unsafe and linked to an increased risk of heart attack. The reports were released just weeks before an important FDA meeting on Avandia’s safety.
One study in the Archives of Internal Medicine is an update of a 2007 analysis of the clinical trials done on Avandia by Steven Nissen, a cardiologist at the Cleveland Clinic. The original analysis was based on 42 studies involving Avandia and showed a 43% increase in the risk of heart attacks. The new analysis looks at 56 clinical studies, including a Glaxo-funded study known as Record, and shows an increased heart attack risk of 28%. If the Record study is removed from the analysis, the risk of heart attacks rises to 39%.
The second study, published in JAMA, was led by FDA drug-safety scientist David Graham, and looked at the outcomes of nearly 230,000 Medicare patients who were treated with Avandia or Actos, a similar drug made by Takeda Pharmaceutical Co. The study looked at a combined endpoint of heart attack, stroke, heart failure or death and found that patients taking Avandia had an 18% increased risk compared to those taking Actos.
FDA Deputy Commissioner Joshua Sharfstein said Drs. Nissen and Graham have been asked to present their findings to the panel of experts when it meets this week. “They are making an important contribution to the discussion of the safety of Avandia,” said Dr. Sharfstein, adding that the agency is taking the Avandia issue very seriously.