FDA panel leaning towards Avandia with restrictions


Food and Drug Administration (FDA) is grilling clinical studies that say Avandia increases risk of heart attack and the ones funded by GlaxoSmithKline say Avandia is safe.  Few days ago, an extensive report on reviewer of clinical studies by GSK revealed that the study had some basic flaws. 

Thirty three member committee of FDA voted to decide on fate of Avandia and here is the distribution of votes 

  • Twelve voted to remove Avandia from the market altogether
  • Seven voted to sell the drug but to add stiffer warnings
  • Ten for continued sale but with new label revisions and possible restriction on its use
  • Three voted to sell Avandia as it is with no changes

It can be deduced that majority of committee members were of selling Avandia with increases restrictions and warnings.

I would like to quote couple of people from article in CNN;Split decision from FDA panel on Avandia”:

Dr. Peter Savage, the director of the National Institutes of Health’s epidemiology division, who voted for stronger warnings and restrictions said

  • I think the evidence of potential harm is stronger now than it was in 2007
  • I think if the drug is to remain on the market, we need to consider whether there would be some specific indications in which it would be reserved for use.
  •  It seems to me that simply putting a warning, a black-box warning, in the labeling is probably not sufficient to really protect patients.


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Dr. Ellen Strahlman, the GSK’s chief medical officer said:

  • Following today’s recommendations, we will, of course, continue to work with the FDA in the best interest of diabetes patients who face this chronic and serious disease
  • Patients taking Avandia should speak with their physician about their treatment and any questions they may have regarding the safety of the medicine.”

Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research acknowledged that FDA officials will make a decision on what to do with the medication “as soon as possible.”  New York Times has covered minutes of FDA review of Avandia and I would encourage you to go through the article “F.D.A. Panel Votes to Restrict Avandia”.  There is definitely shift in opinion as compared to 2007, wherein FDA gave clearance to Avandia without any restrictions.  I am eagerly waiting FDA’s final verdict on Avandia and I hope patient’s safety will not be compromised.

Source: nytimes

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