FDA Considering End to Avandia Safety Study


According to a Wall Street Journal article published this weekend, the US Food and Drug Administration is considering ending a safety study on GlaxoSmithKline’s Avandia diabetes drug, generic name rosiglitazone, because of concerns that it increases heart attack risks. Avandia is already required to carry a black box warning to alert consumers of the increased potential for heart attack.

The agency had originally planned a public meeting at the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committee in July when the review into the drug’s safety was completed. However, WSJ reports that the review may end sooner.

According to the article, FDA commissioner Margaret Hamburg is reassessing the TIDE (Thiazolidinedione Intervention with Vitamin D Evaluation) trial which began in 2007 that compares Avandia to a similar medication called Actos (pioglitazone), made by Takeda Pharmaceutical Company. The Agency is also reviewing data submitted in August 2009 from the RECORD study that link Avandia to potentially fatal side effects.

Both Avandia and Actos carry warnings that the drugs may cause or exacerbate congestive heart failure, but Actos does not appear to cause heart attacks, angina, or stroke as is the concern with Avandia. A study published in November 2008 in the Archives of Internal Medicine found that the risk of death and heart failure was greater in older people with diabetes taking Avandia versus Actos. In February, the New York Times uncovered a confidential report that recommended the removal of Avandia from the US market as it was linked to over 300 deaths in the third quarter of 2009.


Even more recently, an analysis of over 200 reviews and articles about Avandia, appearing in the March 18 issue of the journal BMJ, has found that experts who were paid by GSK were significantly more likely to draw positive conclusions about the drug’s safety and efficacy. Independent reviewers with no conflicts of interest graded each article as “favorable”, “neutral”, or “unfavorable” and then correlated those findings with those who had been paid or had other potential conflicts with Glaxo.

Of those who offered favorable reviews, 87% had links or potential conflicts of interest to GSK. Among those with negative opinions, 20% had received money for their evaluations. Of the 90 articles with potential conflicts, only 69 of them had a statement disclosing the fact.

In defense of the review, Mary Anne Rhyne, a spokeswoman for Glaxo, said, “Of the 202 articles, only 10 were original scientific research. Many of the articles reviewed were opinion pieces — editorials, commentaries or letters. It is important to note that the authors’ conclusions do not impugn the validity of the scientific data.” However, she does state that GSK will “disclose research payments made to health care professionals and their institutions” beginning in 2011 that will cover research that began on or after January 1, 2010.

Last month, the Food and Drug Authority of Saudi Arabia suspended Avandia for six months, becoming the first healthcare regulator to do so. The Authority says that the potential risks of the drug far outweigh its benefits.

For those currently taking Avandia, do not stop taking the medication without first talking to your healthcare provider. Untreated and uncontrolled diabetes carries a significant risk of complications. Should you have any side effects that you believe are associated with the medication, you are asked to report to the FDA MedWatch program.