Pharmaceutical International News - June 2011
Cancer Fears Cause French Actos Drug Ban
Posted by Pharmaceutical International's Senior Journalist on 10/06/2011 - 15:45:00
French drug regulators have moved to ban diabetes treatment Actos over concerns that it could cause bladder cancer.
AFSSAPS (Agence Francaise de Sécurité SAnitaire des Produits de Santaire - France's Medicines Agency) has pulled both Actos and a compound drug that contains it, Competact, following a major study that links the Takeda Pharmaceuticals pill to a moderately elevated bladder cancer risk.
From now on, new Actos prescriptions won't be available to French patients, while those already taking it are advised to carry on for the moment, but to discuss the situation with their doctors, too.
French Actos Drug Ban
Since news of the French Actos drug ban first broke, Germany has now taken a similar lead but other European nations are yet to decide the future of Actos. That's according to information included in a statement released by the European Medicines Agency (EMA) which, three months ago, launched a study into the top-selling drug.
At approximately the same time, a group of scientists described how, over a five year period starting in 2004, over 500,000 adverse reactions were reported to the US Food and Drug Administration by patients taking diabetic drug treatments.
In comments printed by the Diabetes Care publication, they added that, of these, 138 concerned bladder cancers that had developed in diabetic patients and, in over 20 per cent of cases, Actos was involved.
Actos Cancer Fears
The scientists stressed that this didn't necessarily construct a link between the diabetes drug and bladder cancer, but it did point towards future studies being required to look further into the Actos cancer fears.
Takeda Pharmaceuticals is the most successful drug firm in Japan and Actos its flagship product, generating about 27 per cent of its revenue. In Japan itself, Actos will remain on sale, its health ministry has confirmed.
Data released by AFSSAPS puts the number of French Actos patients at about 230,000. It's been available to diabetic patients there since the year 2000. The next step in Actos' career may be decided by the end of June, by which time the EMA is due to have held a meeting on it.
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