Actos FDA Warnings from 2007 Until 2011
Actos was originally approved by the FDA in 1999 to improve blood sugar control in adults with type 2 diabetes, either when used alone or with other medications. The medication is now taken by more than 2 million patients every year in the U.S. and had global sales of more than $4.8 billion.
A review of "post-market adverse medical events" — real-life medical problems experienced by patients who used the drug — led the U.S. Food and Drug Administration (FDA) in 2007 to require that the manufacturer change the label to warn patients about serious side effects leading to significant health problems and death.
In 2007, manufacturers of Actos and other anti-diabetic drugs, such as Avandia, Avandaryl, Avandamet and Duetact, were all required to add a boxed warning that use of the drugs could cause or worsen heart failure. A boxed warning is the FDA's strongest form of warning. It was issued because patients were being prescribed the drugs without careful monitoring for signs of heart failure, which include rapid weight gain, edema and shortness of breath.
Attorneys bringing Actos litigation say that Actos manufacturer, Takeda, knew of the increased risk of bladder cancer in 2008, but did not withdraw the drug from market.
In September 2010, the FDA announced it was reviewing the safety of Actos after a study by Kaiser Permanente (health insurer) demonstrated that users of the drug had an increased risk of developing bladder cancer. Although animal and human studies suggested there was a higher risk, the FDA had not yet reached a conclusion.
In May 2011, the FDA reported that a five-year study of a half million "adverse event" reports suggested an increased risk of bladder cancer. Of patients who reported bladder cancer, 20 percent were taking Actos. The FDA advised that Actos not be prescribed to patients with active bladder cancer and cautioned use for patients who had previously had bladder cancer.
Summer 2011, the FDA announced that use of Actos (and other Pioglitazone-containing medicines) for more than one year may be associated with an increased risk of bladder cancer. It required drug manufacturers to again revise the patient information included with the prescription to discuss cancer risks.
Pioglitazone Recall Alert: Studies conducted in France resulted in the French government requiring a recall of Actos and the German government advising doctors to cease prescribing Actos to their patients. In the U.S., there has not been an FDA recall yet.
While the FDA has not issued a recall of Actos, litigation has begun across the U.S. by patients who have developed bladder cancer, renal failure, liver failure and heart failure associated with use of the drug.
Contact Phoenix, Arizona, Injury Lawyers
If you or a family member has suffered one of these dangerous side effects of Actos, talk to an experienced defective drug lawyer at Knapp & Roberts law firm. Your consultation is free and can provide you with valuable information and advice regarding Actos FDA warnings and your potential legal case. Contact our Scottsdale or Phoenix, Arizona, injury lawyers.
Our firm has extensive experience with defective drug and medical product cases, medical malpractice and product liability. Learn more about why it's important to hire an EXPERIENCED lawyer when you are involved in a complex drug liability case like Actos litigation.