Agency believes that benefits do outweigh risks for some type 2 diabetes patients.
EMA is recommending that type 2 diabetes patients with current bladder cancer, a history of the disease, or uninvestigated macroscopic hematuria, should not be prescribed drugs containing Takeda’s Actos (pioglitazone). The recommendation follows a data review by the agency’s CHMP, which concluded that while pioglitazone-based medicines remain a valid treatment option for some patients with type 2 diabetes, the drug is associated with a small increased risk of bladder cancer.
The CHMP review in addition recommended that prescribers should review the treatment of patients on pioglitazone regularly to ensure that only those who are deriving sufficient benefit continue to take it.
EMA’s findings follow just a month after FDA similarly concluded that use of the diabetes medication Actos for more than a year may be associated with an increased risk of bladder cancer. The European agency’s review also found that patients treated for the longest duration and with the highest cumulative doses were at particular risk.
EMA in addition noted that a possible risk after short-term treatment can’t be excluded. It reports a meta-analysis of randomized controlled trials showed that pioglitazone was associated with a 0.15% overall risk of bladder cancer compared with a 0.07% risk among patients not taking the drug.
CHMP noted that while it wasn’t possible to further restrict the current indications of pioglitazone but recommended that prescribers should instead carefully select patients and monitor their responses to treatment. Moreover, in light of age-related risks, the balance of benefits and risks associated with the drug should be considered carefully both before initiating and during treatment in the elderly.
The European agency is also calling for further analyses of the types, evolution, and severity of bladder cancer in patients treated with pioglitazone and is calling for the a pan-European epidemiological study focused on characterizing pioglitazone-associated risks further.
In June when FDA reported its recommendations, Takeda stressed that a 10-year epidemiological study, started in 2002 by the University of Pennsylvania and Kaiser Permanente Diabetes Registry, Northern California (KPNC), was in progress to investigate the questions raised about ACTOS and bladder cancer. Both FDA and EMA have been provided with interim data from this study on a regular basis. The Japanese firm will continue to support the study through its conclusion, which is expecte at the end of 2012.