European Medicines Agency updates on pioglitazone, Pandemrix and Champix

Yesterday saw a batch of recommendations from the European Medicines Agency’s advisory body, including on: Takeda’s (TYO: 4502) Actos (pioglitazone) and other brands with the same active ingredient; GlaxoSmithKline’s (LSE: GSK) flu vaccine Pandemrix and Pfizer’s (NYSE: PFE) smoking cessation product Champix (varenicline).

Finalizing its review on antidiabetic pioglitazone-containing medicines and the occurrence of bladder cancer, the EMA’s Committee for Medicinal Products for Human Use (CHMP) confirmed that these medicines remain a valid treatment option for certain patients with type 2 diabetes but that there is a small increased risk of bladder cancer in patients taking these medicines. However, the CHMP also concluded that the small increased risk could be reduced by appropriate patient selection and exclusion, including a requirement for periodic review of the efficacy and safety of the individual patient's treatment.

Prescribers are advised not to use these medicines in patients with current or a history of bladder cancer or in patients with uninvestigated macroscopic haematuria. Risk factors for bladder cancer should be assessed before initiating pioglitazone treatment. In light of age-related risks, the balance of benefits and risks should be considered carefully both before initiating and during treatment in the elderly. Prescribers should review the treatment of patients on pioglitazone after three to six months (and regularly afterwards) to ensure that only patients who are deriving sufficient benefit continue to take it.