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Published: May 1st, 2011
Side effects of the popular diabetes drug Actos may increase the risk of bladder cancer. Health regulators in some European countries have suspended sales of the drug and the FDA required new warnings about the potential risk of bladder cancer from Actos in June 2011.
STATUS OF ACTOS BLADDER CANCER LAWSUITS: As a result of the manufacturer’s failure to adequately research the side effects of Actos or warn about the risk of bladder cancer, compensation may be available through an Actos lawsuit.
MANUFACTURER: Takeda Pharmaceuticals
OVERVIEW: Actos (pioglitazone) was approved by the FDA in July 1999 as a treatment for type 2 diabetes. It is part of the same class of drugs as Avandia (rosiglitazone), which has been linked to an increased risk of heart attacks and other health problems. In recent years, use of Actos has increased as some studies have suggested that the diabetes medication may be safer than Avandia.
Recent research has suggested that Actos side effects may increase the risk of bladder cancer the longer the medications is taken.
BLADDER CANCER SIDE EFFECTS OF ACTOS: Early data from an on-going 10 year study of Actos side effects conducted by Takeda Pharmaceuticals has suggested that users of the diabetes drug may face an increased risk of cancer when the medication is taken for more than a year.
In September 2010, the FDA announced that the potential Actos bladder cancer risk was being reviewed and evaluated.
According to five-year data from the study, which involves 193,099 patients with data, patient taking Actos for 12 months or longer had a 40% increased risk of developing bladder cancer. The risk increased with both dose size and duration of treatment.
In May 2011, a new study was published that provided further evidence that suggests Actos side effects may increase the risk of bladder cancer. Looking at adverse event reports made to the FDA, researchers found that about one-fifth of all reports involving bladder cancer among diabetes drug users involved Actos. Although the study does not establish a causal effect between Actos and bladder cancer, researchers suggested that there may be a disproportionate risk in comparison to other diabetes drugs.
Drug regulators in France and Germany decided to suspend sales of the drug, essentially issuing an Actos recall, in June 2011, after a review of public insurance data revealed an increased occurrence of bladder cancer.
On June 16, 2011, the FDA announced that new warnings about the risk of bladder cancer from Actos will be added to the medication label in the warnings and precautions section. Similar warnings will also be added to other medications that contain pioglitazone, the active ingredient in Actos; including, Actoplus Met, ActoplusMet XR and Duetact.