Image by insearchofbalance via FlickrAvandia, GlaxcoSmith Kline’s blockbuster diabetes drug, has faced intense scrutiny the last three years for links to heart problems. Last Friday, Time magazine reported that deputy FDA commissioner Josh Sharfstein said the agency is investigating whether Glaxo broke the law by holding back data from the FDA indicating the drug carried an increased risk of heart attacks.
Sen. Chuck Grassley, the ranking member of the Senate Finance Committee has been investigating Glaxo and Avandia for over two years, and released dozens of internal Glaxo documents in February, 2010 relating to those potential cardiovascular risks. The committee sent copies of those documents to the FDA.
In July, 2010 GSK received disturbing news from the FDA.
The FDA ordered GlaxoSmithKline to stop enrolling new patients in a clinical trial of its diabetes drug, Avandia.
The clinical trial, called TIDE, was mandated by the FDA to assess safety risks of the drug, which is prescribed to treat type-2 diabetes.
The FDA said the action does not mean the drug will be removed from the market. But the agency is demanding that GlaxoSmithKline update physicians and ethics oversight boards involved in the trial regarding all new safety information about the drug.
The second was the when 21 members of the 33 member Food and Drug Administration advisory committee panel voted to restrict the sales of Avandia due to its potential risk for causing heart attacks.
Twelve voted to completely remove Avandia from the market; 10 voted for allowing sales to continue but with new label revisions and possible restrictions; 7 voted to add more warnings while 3 voted for no change at all. We’ll be watching the final decision from the FDA.
OUR FIRM IS INVESTIGATING AVANDIA CLAIMS.
CONTACT CHRIS HELLUMS TODAY FOR A FREE CASE EVALUATION: 866-515-8880 or Chrish@pittmandutton.com .
For further research and investigation read:
• Wall Street Journal Blog: “Another Twist in the Chronicles of Avandia!”
• 33 Member FDA panel votes to restrict Avandia