Safety Concerns Of Actos

The Type 2 diabetes medication Actos has come under scrutiny lately due to many safety concerns such as heart failure and bladder cancer. The drug was approved by the FDA in 1999 and is manufactured by Takeda Pharmaceuticals. In 2010 the drug sold a total of $3.5 domestically alone. Takeda’s patent has since expired and the negative media coverage of its side effects have caused sales to decline.

Side Effects
Serious side effects of taking Actos include heart failure and, in particular, bladder cancer. The FDA announced in 2011 that long-term use of Actos may correlate to a greater risk of bladder cancer. This came after a decade-long medical study on the effects of Actos on patients. The greater the exposure to Actos, either by a higher dosage or prolonged use, causes a greater risk for bladder cancer. The FDA instructed health care professionals to not prescribe the drug to patients with a history or currently afflicted by bladder cancer. In 2007 the Actos class of diabetes medications was determined to possibly cause heart failure in patients as well.

Legal Liability
Product liability law manufacturers are required to make sure that their products do not cause any unreasonable dangers or defects. Many have filed claims against Takeda, as well as Lilly, and in order for them to be successful it must be proved that the product was defective and that the defect caused injury.

Warning Defects
Warning defects, manufacturing defects and design defects are all areas of concern but in the Takeda cases the first is being considered because plaintiffs claim they were not properly educated.

Conclusion
Currently Takeda is battling a $9 billion lawsuit for a ruling that said the drug causes bladder cancer. Other lawsuits are underway as well and damages have already been awarded in some cases such as the Bellwether case which awarded $6 billion in punitive damages and $1.5 million in compensatory damages.