April 29, 2010

Avandia was approved by the FDA in 1998 to treat type 2 diabetes.  It has been estimated that Avandia has caused between 60,000 and 200,000 heart attacks and deaths in the United States between 1999 and 2006.  By 2007, the FDA ordered GlaxoSmithKline to place a black-box warning on Avandia’s packaging to warn consumers that Avandia was linked to an increase in heart failure.  Reports from the Senate Finance Committee accused GlaxoSmithKline with attempting to minimize GlaxoSmithKline’s own findings about Avandia side effects.  Most recently, the Senate Committee revealed that a number of  FDA reviewers had been calling for an Avandia recall since 2007.  This summer, the FDA plans to conduct an advisory committee to review all the evidence from recent clinical trials as well as earlier studies performed by Avandia’s manufacturer.

Saudi Arabia’s Food and Drug Authority Suspends Use of Avandia

In response to reports from the Senate Finance Committee and the FDA, the Saudi Arabia Food and Drug Authority (SAFD) has suspended the use of Avandia for a six-month period while reviews are underway.  The SAFD says that “safety is a big issue” with Avandia, based on its review of clinical trials.  In Saudi Arabia, Avandia will still be prescribed, but prescriptions will not be filled pending further investigation.  Saudi Arabia believes the risks of Avandia far outweigh its benefits, particularly in light of the fact that safer alternatives exist.  The SAFD met with GlaxoSmithKline to inform GSK of its decision, and offered to allow the company more time to provide the SAFD with information that might help change the SAFD’s position.  The director of the SAFD, Al-Humaidan, said that after six months GSK had still not provided any information, and, as far as he was concerned, Avandia should be pulled from the market.

If you have experienced a heart attack or any other heart related illness while on Avandia you may be interested in speaking with a lawyer about Avandia side effects to see if you are entitled to compensation for medical costs, pain and suffering.

Author

Susan Ardizzoni, Ph.D. holds a Doctorate in Biology with a major in Neuroscience (medical) and minors in Biochemistry, Physics, and Mathematics with experience in basic and clinical research.  Although the author is not an attorney, this article was sponsored by the law firm of Bernstein Liebhard LLP and constitutes Attorney Advertising.  To learn more about Avandia side effects or Avandia recall please visit www.ConsumerInjuryLawyers.com