FDA Places Harsh Restrictions on Avandia
WASHINGTON, DC – The US Food and Drug Administration (FDA) announced new, severe restrictions on GlaxoSmithKline’s heavily scrutinized diabetes medication Avandia on Thursday, September 23. The European Medicines Agency announced the same day that Avandia was to be completely removed from the market in Europe.
FDA’s decision has raised the profile of Avandia’s health risks, which have been in the news for months. So far, Avandia has been linked to an increased risk of:
- •Heart disease
- •Heart failure and heart attacks
- •Bladder cancer
- •Pulmonary embolism
- •Bone fractures
If you or someone you know has developed any of the above conditions after taking Avandia, you may have grounds for an Avandia defective drug lawsuit. The pharmaceutical injury law firm of Schlichter, Bogard & Denton has a strong record in pharmaceutical injury litigation and is ready to help you build your case and seek fair financial compensation.
Suppressing Risks and Scratching Backs
In fact, there is evidence that GSK knew about the risk of heart attacks even before Avandia was approved by the FDA in 2000, but hid the evidence from regulators. In addition, some members of FDA panels that issued earlier regulatory decisions on Avandia have in the past received payments from GSK for speaking engagements. These shady practices and conflicts of interest in the FDA’s approval process and regulatory process are likely to be factors in Avandia defective drug lawsuits nationwide.
Even before the FDA’s September 23rd decision to allow only patients who do not respond to any other diabetes medication access to Avandia, plaintiffs across the United States had already been bringing defective drug lawsuits for Avandia-related heart attacks. Reuters reported in July that GSK had agreed to $460 million in Avandia settlements to about 10,000 plaintiffs.
Now that the FDA has severely restricted Avandia, judges and juries will likely find Avandia pharmaceutical injury claims against GSK more credible.
If you or a loved one has developed heart problems or had a heart attack or stroke after taking Avandia, please contact the defective drug injury attorneys of Schlichter, Bogard & Denton today to discuss your legal options.