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Side Effects of Avandia & FDA Restrictions on Avandia

9 Feb 2011 Avandia is an anti-diabetic drug for type 2 diabetic patients. The generic name of this drug is Rosiglitazone, belonging to the thiazolidinedione class of drugs. This drug works as an insulin sensitizer. Rosiglitazone is produced by GlaxoSmithKline (GSK) and marketed in the name of Avandia as a stand alone drug.

Avanndia was a very popular drug till a few years back. Infact GSK achieved an annual peak sales of approximately $2.5bn in 2006. Over 6 million people worldwide have been using Avandia since its production. However this drug has slowly lost its popularity after reports of severe side effects of the drugs. In many countries , the drug has already been banned. A safety alert was issued in 2007 by the FDA. The drug is still in use in USA as as per law, the drug's patent expires in 2012.

Avandia Side Effects

Some of the mild Avandia side effects include headache, back pain, fatigue, and sinusitis, among others. However the drug has been linked to other severe side effects like

  • Liver Failure and Liver toxicity
  • Bone Fractures
  • Edema
  • Fluid retention
  • Low blood pressure
  • Heart Failure

Of all the side effects, risk to the heart has been the one of the main factor of this Type 2 diabetes drug that has been the major concern, and the most controversy.

Hard facts of Avandia: Avandia FDA
  • USFDA had alerted against rosiglitazone avandia 's possible side-effects way back in 2007 diue to a report published in the New England Journal of Medicine that the users of this drug are at a 60 % greater risk of heart failure and a 29% greater risk of death compared to other medicines
  • A well known American cardiologist Professor Steve Nissen, wrote the report on this drug and its associated cardiovascular risks in 2007.
  • India's National Pharmaco Vigilance Advisory Committee had reviewed the scientific data in 2008 Jan requesting all manufacturers of avandia to carry a black box warning on its package, about its possible risks.
  • Union health ministry of India decided to ban rosiglitazone with immediate effect all over India on October 7, 2010
  • While Avandia has been banned outright by the EU, the FDA couldnot ask GSK to pull Avandia from the market. Instead, an advisory panel in 2010 decided to allow Avandia to remain, albeit with severe restrictions. Those restrictions are now reflected on the Avandia label for US product.
  • According to the reports of the Associated Press on 7th Feb 2011, the Avandia label (for US product) display the FDA recommendations that this drug is only advisable for patients who are unable to control their blood sugar levels with any other diabetes medication.
Avandia Lawsuit

Avandia lawsuits have resulted because of the serious Avandia side effects, including congestive heart failure, hepatitis, and liver failure. While thousands of lawsuits brought against GSK have already been settled, including lawsuits for Avandia death, there were more lawsuits produced as a result of the announcement of more severe restrictions by the FDA in September, 2010.