Concerns about dangerous side effects caused by the type 2 diabetes medication Actos were raised in a June 15, 2011 Food and Drug safety announcement that should be reviewed by any patient who has or is using this medication.
The safety announcement was issued after the agency reviewed a study sponsored by Actos manufacturer Takeda Pharmaceuticals which documented an increased risk of developing bladder cancer with Actos than other diabetes drugs.
Here is part of the safety announcement:
“The U.S. Food and Drug Administration (FDA) is informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.”
Takeda Pharmaceuticals, which has been described as being Asia’s largest drug manufacturer, has been sued by more than 3,000 patients who used Actos over health problems they attribute to the medication.
They claim that Takeda researchers ignored, downplayed or tried to cover up knowledge they had about whether Actos could cause bladder cancer and that they misled regulators about its risks and failed to warn consumers about this possible side effect.
Legal experts say that the number of cases involved put Takeda at serious risk of suffering legal costs and judgments that could run into the billions of dollars.
The medication has been immensely profitable for Takeda. Bloomberg News reported that sales of Actos peaked in the year ended March 2011 at $4.5 billion and accounted for 27 percent of Takeda’s revenue at the time.
The news agency also reported that Actos has generated more than $16 billion in sales since its 1999 release, according to court filings.