Avandia may be far more dangerous to patients than reported in a study touted by the drug’s manufacturer, according to a strongly worded report posted by the FDA.
*** 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?
July 13, 2010 – As the FDA prepares to consider whether to ban Avandia, agency scientists have discovered flaws that disqualify a clinical study sponsored by its maker. The trial, organized by GlaxoSmithKline (GSK), sought to evaluate the relative heart risks of Avandia and two other diabetes drugs, but was an “open label” trial, meaning the researchers and patients knew which drugs they were getting.
The analysis by Dr. Thomas Marciniak says the officials overseeing the so-called RECORD study repeatedly submitted sloppy data and failed to follow up on reports of problems in patients — including reports of patient deaths. He also called the design of the study “inappropriate and biased.”
The analysis was posted along with more than a thousand pages of additional documents being weighed by an FDA panel, ahead of this week’s meeting when members will debate a series of steps that could include removing Avandia from the market.
Marciniak did an intensive review of patient records, and said that in many cases there was missing data, or that investigators failed to follow up on likely cases of heart problems. In most cases, he wrote, the omissions made the safety data for Avandia look better than it really was. Once he re-analyzed the data, he wrote, it actually shows an increased risk of heart attack — much like the studies it was meant to refute.