Actos Removed From French Markets Due to Negative Side Effects

French Health Minister Xavier Bertrand has pledged to overhaul the country's drug approval and monitoring system to try and prevent further deaths and accidents within the industry. Takeda Pharmeceutical Company recently announced the withdrawal of its pioglitazone-containing product Actos from French markets due to concerns that the drug may cause significant negative medical deficiencies due to the dangerous side effects that may occur.

Actos is a medication that helps treat type 2 diabetes and was marketed as something that would curb many of the symptoms of the disease, according to a company release.

The decision to suspend the product came out of the increased risk for bladder cancer in patients that was observed in the French medical field, the release noted.

These observations were made during a French database study (CNAMTS) that was independently conducted by the authorities. This was a small part of a pan-European review of pioglitazone-containing medicines by the European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), according to the release.

The CHMP will discuss the further risks of this drug in the immediate future and will come up with a revised plan for how to deal with the repercussions that have come from usage by patients and possible increases in likelihood for bladder cancer.

Initial marketing authorizations for the drug were made by the European Commission on October 13, 2000, as Actos was made available throughout the EU on this date, the release noted.

While the move was made to prevent any further damage to patients, immediate withdrawal for Actos should be done only with consultation of a medical professional, according to Bloomberg.

Authorities in France have begun to tighten their surveillance on new drugs that have come into the market due to the many side effects that are not reported until after the medication has gone into circulation. A previous diabetes medicine, Mediator, was blamed for the deaths of as many as 2,000 patients, reported the news source.

French Health Minister Xavier Bertrand has pledged to overhaul the country's drug approval and monitoring system to try and prevent further deaths and accidents within the industry. The authorities in France were not the only government agency that was worried, as the U.S. Food and Drug Administration has been monitoring Actos very closely, Bloomberg reported.

FDA officials noted the increased risk for bladder cancer and have begun steps to monitor the drug further because of the harm that it may cause to U.S. citizens, according to the news source.