After a study showed a slight increased risk of developing bladder cancer among patients taking Actos (pioglitazone) and Competact (metformin with pioglitazone), French regulators announced that they have suspended the use of Actos and Competact, both diabetes medications. German regulators followed suit, and have informed Takeda, the maker of the two drugs, that they are doing the same.
AFSSAPS (Agence francaise de sécurité sanitaire des produits de santaire), the French Medicines Agency, decided to suspend the medications after evaluating new data from a retrospective cohort study which demonstrated a slight rise in bladder cancer risk among patients taking medications with the active ingredient pioglitazone. The study had been carried out in France.
AFSSAPS stressed that patients must not stop taking Actos or Competact without checking with their doctor. The Agency says approximately 230,000 people in France take drugs containing pioglitazone.
EMA (European Medicines Agency) is meeting later this month to discuss alleged bladder cancer risk linked to pioglitazone. The Agency is currently carrying out a probe into the safety of the drug.
EMA says that for the moment it is not making any recommendations.
The FDA (Food and Drug Administration), USA, is also investigating whether there might be a potential link between bladder cancer and pioglitazone.
When the FDA investigation started, in September 2010, it said early results from a long-term observational study had not detected any overall association between bladder cancer risk and pioglitazone. There appeared to be a slightly raised risk among those taking Actos long-term, and patients with the highest cumulative dose of the drug.
Pioglitazone is a thiazolidinedione (TZD) class medication with hypoglycemic action – it brings down blood-sugar levels in patients with diabetes. In the UK, USA and Germany it is known by brand name Actos, Glizone and Pioz in India, and Zactos in Mexico.
Takeda Pharmaceuticals earned 387.9 billion yen ($4.8 billion) in worldwide sales of Pioglitazone last year – 27% of the company’s revenue. It was the tenth best-selling drug in America in 2008.
Pioglitazone is taken by patients with diabetes type 2, either on its own or together with metformin or insulin. It is being used experimentally to treat patients with fatty liver (non-alcoholic steatohepatitis). Studies showed that pioglitazone can significantly reduce the chances of conversion from prediabetes to diabetes type 2. Its chemical formula is C19H20N2O3S.
Written by Christian Nordqvist