Controversy and concern continue to plague the prescription Diabetes 2 medication, Avandia. An FDA advisory panel convened again last month to determine what action to take concerning the product, especially with regard to patient safety. Numerous studies indicate Avandia poses an extensive risk of complicating heart disease and contributing to cardiac arrest. Lawsuits against the medication manufacturer, GlaxoSmithKline, have cost the company $256 billion so far. Three thousand suits are still unresolved. Lack of Ethics
GSK came under scrutiny when officials believed the company neglected to reveal health threatening side effects associated with taking Avandia. The drug, generic name rosiglitazone, causes fluid retention in patients. Fluid accumulating in significant quantities creates weight gain and swelling, posing substantial risks to patients with heart disease.
A study published by the New England Journal of Medicine revealed that patients using the medication, combined with insulin or nitrates (nitroglycerin or Isosorbide), were at a 43% greater risk of experiencing a heart attack and were 64% more likely to die from cardiac complications.
The lack of ethics on the part of GlaxoSmithKline surrounding the medication continues. A group of physicians is currently conducting a Tide Trial of Avandia versus Actos, a similar medication. The FDA instructed GSK to notify the scientists of the impending hearing.
Documents the company relayed to the study suggest the manufacturer neglected to include all arguments and concerns related to Avandia. The FDA also ordered GSK to cease recruiting patients for the study as the organization felt people were unnecessarily enduring exploitation. Avandia sales and stocks continue a steady rate of decline.
GSK’s Avandia problems began in 2007 when negative information surfaced following many independent studies. Dr. David Graham, employed by the FDA in the Office of Surveillance and Epidemiology, has been working diligently to remove Avandia from the market for the purpose of patient safety. In maintaining public safety, the physician played a crucial role in eliminating Vioxx from the US market.
Dr. Graham and staff also recently concluded an investigation of over 200,000 Medicare records and concluded that elderly patients using Avandia were 25% more likely to suffer a cardiac event and 14% more likely to die from cardiac complications.
Advisory Panel Conclusion
Though many physicians believe the medication presents dangerous side effects that outweigh patient benefits, the FDA committee voted to keep the medication on the market. Many accuse the FDA committee of favoring the drug against all logic (even the European panel voted to withdraw Avandia), suggesting corruption in the panel.
As a compromise, the FDA now requires physicians prescribing the medication to provide extensive documentation. Health care providers must indicate what treatment modalities patients used before necessitating the use of Avandia. Documentation also requires patients acknowledge receiving and comprehending all information concerning the potential for life threatening side effects.
If you or a loved one suffered injury due to a dangerous drug like Avandia, you have a right to be compensated. Contact our office for a free evaluation of your case. We believe in finding justice for those injured by this dangerous drug.