Effective today, the diabetes drug Avandia will only be available through certified mail-order pharmacies. These new restrictions are designed to limit the number of people exposed to potential heart side effects of Avandia.
The FDA allowed Avandia to remain on the market last year, subject to a new risk evaluation and mitigation strategy (REMS). This special program limits sales of the medication to mail order and requires educational programs before it can be prescribed.
Today, is the last day Avandia will be available on retail pharmacy shelves. To continue receiving the medication after this week, healthcare providers and patients must enroll in the Avandia-Rosiglitazone Medicines Access Program.
These new restrictions also affect Avandamet and Avandaryl, which also contain the active pharmaceutical ingredient Rosiglitazone.
The retail market for Avandia has been severely restricted because of an increased risk of heart attacks and heart problems associated with the diabetes medication. According to experts, more than 100,000 heart attacks may have been caused by Avandia since introduction.
A “black box” warning was added to Avandia in the United States in November 2007, but according to many medical experts, the warning was not strong enough and they pressed for the FDA to ban Avandia. Medical studies had revealed that the risks greatly outweigh any minimal benefits.
Thousands of Avandia lawsuits have been filed on behalf of individuals who have suffered serious and sometimes fatal injuries. The complaints allege that GlaxoSmithKline failed to adequately research the side effects of their medication or warn about the potential heart risks. Avandia settlement agreements have been reached in many of the cases, but approximately 20,000 injury lawsuits are still pending in courts throughout the United States.
Actos (pioglitazone) was introduced as a treatment option for type 2 diabetes in July, 1999. And after problems were identified with Avandia, Actos rapidly became a blockbuster drug.
The Actos problems with bladder cancer first surfaced in September 2010, when the FDA released an early communication about interim data from an on-going 10 year study that found Actos users may face an increased risk of bladder cancer. And the risk apparently increased with the duration of use of the medication.
In June 2011, France recalled Actos after a review of public insurance data identified an increased incidence of bladder cancer with Actos use.
In the United States, new Actos cancer warnings were approved by the FDA in August 2011, indicating that patients who use the drug for more than a year may face an increased risk of bladder cancer. So far, the FDA has not issued a “black box” warning, but some experts think that this may happen, as seen with Avandia.
Actos lawsuits throughout the United States have have been filed against the drug manufacturer, Takeda Pharmaceuticals. The complaints allege that Takeda failed to provide adequately warnings for consumers or the medical community about the risk of bladder cancer. Many of the complaints also allege that Takeda should have recalled Actos from the market, arguing similarly to Avandia, the risk of bladder cancer outweighs the minimal benefits.
Hundreds of cases have been filed by Actos users diagnosed with bladder cancer after using the diabetes drug. A panel of judges is scheduled to meet on December 1 to decide whether all federal Actos lawsuits should be consolidated as part of an MDL, or multidistrict litigation.