In recent months, Actos has come under increased scrutiny by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and France’s drug safety authority (French Medicines Agency or Afssaps) with the French agency suspending sales of Actos on June 9, 2011.
This latest response has come as the result of an ongoing study which has found an increased risk of developing bladder cancer among patients who taking the highest doses of Actos over an extended period of time.
ACTOS AND BLADDER CANCER
The French National Health Insurance Plan conducted an investigation that showed a significant increase in the risk for bladder cancer in patients taking pioglitazone compared to patients taking other anti-diabetic agents (after adjusting for age, sex, and use of other anti-diabetic medications).
According to the French review, a cumulative dose of greater than 28,000 milligrams and an exposure of longer than one year led to a significant increase in bladder cancer, particularly in men.
In June 2011, the French Medicines Agency suspended use of Actos use while the European Union’s European Medicines Agency (EMA) completed a risk/benefit analysis of the drug. In late July, the EMA confirmed an increased risk of bladder cancer, but determined that the benefit of Actos outweighed the risk for some patients and mandated a three- to six-month review of each individual patient. The EMA further concluded that bladder cancer could be lessened by patient selection and exclusion.
ACTOS AND THE HEART
Following a review of adverse event reports, the U.S. Food and Drug Administration (FDA) determined that updated labeling warning of the risks of heart failure were needed for Actos and all other drugs belonging to the thiazolidinedione class of antidiabetic drugs. According to the November 2007 FDA safety notice, “The strengthened warning advises healthcare professionals to observe patients carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema after starting drug therapy. Patients with these symptoms who then develop heart failure should receive appropriate management of the heart failure and use of the drug should be reconsidered.”
ACTOS AND BONE FRACTURES
In 2007, Takeda Pharmaceuticals (the manufacturer of Actos) issued a notice to healthcare providers advising of recent safety data concerning Actos and an increase in female patient bone fractures. According to the notice, The majority of fractures observed in female patients who received pioglitazone [Actos] were in the distal upper limb (forearm, hand and wrist) or distal lower limb (foot, ankle, fibula and tibia).
The attorneys at Langdon & Emison have litigated a number of cases involving national brand name drugs, including: Yaz/Yasmin (Ocella birth control pills), Beyaz birth control pills, HRT (hormone replacement therapy), Fosamax, Avandia and Accutate. As one of the nation’s preeminent product liability law firms, Langdon & Emison has successfully represented clients in numerous pharmaceutical and medical device matters.
If you or a member of your family has suffered a serious injury caused by a related Actos side effect, you may be able to seek compensation for your losses and suffering. Please feel free to contact the law offices of Langdon & Emison for a free evaluation of your case.
