Following concerns that it hid important clinical data on Avandia, drug maker GlaxoSmithKline (GSK) has now agreed to share more clinical data. GSK was recently fined for withholding safety data about the risk of Avandia side effects from the U.S. Food and Drug Administration. The FDA has severely restricted the uses for Avandia, and GSK has faced hundreds of Avandia lawsuits. In July 2012, the drug company agreed to pay $3 billion in criminal and civil fines following allegations the company did not give the FDA important safety information about Avandia, including information concerning the risk of heart problems linked to the drug. The settlement also covered allegations concerning the off-label marketing of Paxil and Wellbutrin.
Of the $3 billion, $1 billion was paid for criminal fines and forfeitures, and $2 billion was to settle state and federal allegations. GlaxoSmithKline had information from its own trials that indicated Avandia was linked to an increased risk of heart attack, but that data was never reported. It was not until Dr. Steven Nissen, a noted cardiologist, published his study in the New England Journal of Medicine – based on information from GlaxoSmithKline trials – that the increased risk of heart problems linked to Avandia became public.
In 2010, the FDA voted to restrict the use of Avandia, severely limiting when and how doctors can prescribe the medication. Following that, sales of Avandia dropped significantly as patients switched to a rival drug, Actos. GlaxoSmithKline also faced lawsuits alleging the company failed to adequately warn patients and doctors about the risks associated with Avandia. In 2010, GlaxoSmithKline reportedly agreed to settle lawsuits involving almost 700 Plaintiffs, who alleged the drug maker hid the risks of Avandia from the public and from the medical community. In October 2012, GlaxoSmithKline announced it would make more of its drug research available in an attempt to increase transparency. That move will include releasing information about experimental drugs. The company said it will have a panel of experts review requests for information sent by researchers and, if approved, data will be made available. Drug companies run trials on their drugs and gather a great deal of research, but most of that data is never made public, or is made public in a way that highlights positive results and downplays negative results.
If you need more information on Avandia, contact Frank Woodson, a lawyer in our Mass Torts Section, at 800-898-2034 or by email at Frank.Woodson@beasleyallen.com.
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