Sunday, March 11, 2012

No Recall Yet for Type 2 Diabetes Drug, Actos

The FDA has joined forces with France and Germany regarding a warning about the Type 2 diabetes drug, pioglitazone, however no recall is expected at this time. Pioglitazone, also known as Actos, is manufactured by Takeda Pharmaceuticals, a Japanese drug company. The drug currently accounts for some 27% of Takeda’s annual revenues. 2008 saw this powerhouse diabetes medication become the tenth best-selling prescription medication in the United States. Over the past year, Takeda has accrued nearly $4.8 billion dollars in revenues through worldwide sales of Actos.

Clinical Studies of Pioglitazone
Pre-clinical studies—in which male rats were given body-weight equivalent doses of Actos—showed an increase in the incidence of bladder cancer while two subsequent clinical studies using human subjects also revealed an elevated risk of bladder cancer. Due to these findings, the FDA mandated that the potential risks be revealed on the label of the drug, ordering a safety review in September, 2010. Takeda additionally agreed to carry out a ten-year observational study in those diabetic patients currently taking Actos, to be conducted on patients from Kaiser Permanente Northern California Health Plan.

Results of Safety Review
Although the results of the FDA-ordered safety review of pioglitazone were less than positively conclusive, the French Agency for the Safety of Health Products nonetheless pulled Actos from the French market this June due to health concerns. France conducted their own safety study, using over 1.5 million diabetic patients who were currently being treated with the drug—a study which more definitively showed a positive correlation between bladder cancer and pioglitazone. This study also pointed to the fact that the risk increases in patients who take the drug for a longer time period than one year. Following on the heels of the French decision, the German Federal Institute for Drugs and Medical Devices advised doctors against prescribing Actos, based on the French study results. As of September, 2011, no other countries have pulled the drug due to safety concerns.

Specific Issues Related to Safety Reviews
The FDA believes the risk of bladder cancer rises following an increase in dosage or use of longer than a year, citing a 40% increased risk in those who fell in these categories. Because the elderly are already more susceptible to bladder cancer an alternative diabetic drug should be used in older patients. The FDA further asserted that doctors should use extreme caution and full assessments when prescribing Actos, avoiding using the drug on those with active bladder cancer or those with a history of this type of cancer. Expect continued updates on the safety of Actos as further studies are concluded.

Author: Sullo & Sullo Attorneys

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