GPs should regularly review patients with diabetes on pioglitazone after European drug regulators issued a formal warning that the drug is linked with bladder cancer.
Pulse reported last month that pioglitazone was under investigation by drug regulatory agencies after evidence emerged that its long-term use could be linked to an increased risk of bladder cancer.
The European Medicines Agency asked its Committee for Medicinal Products for Human Use to scrutinise safety data for pioglitazone, after data merged from an unpublished French study found a statistically significant 22% increase in the risk for bladder cancer in patients exposed to pioglitazone compared with those exposed to other anti-diabetic agents.
At a meeting last week the committee decided pioglitazone ‘remains 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.’
The regulator stopped short of withdrawing the drug from the market, and noted that ‘the 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.’
It recommended GPs review patients on pioglitazone three to six months after initiation, and regularly thereafter, ‘to ensure that only patients who are deriving sufficient benefit continue to take it.’ The advice has been endorsed by the MHRA.
GPs are also advised not to prescribe pioglitazone in patients with current or a history of bladder cancer or in patients with uninvestigated macroscopic haematuria.
Following the same series of meetings, the EMA also confirmed a positive benefit-risk balance for varenicline following a study by UK researchers which reported a relative increase in the risk cardiovascular events.
It also recommended restricting the use of Pandemrix in children and adolescents under 20 years, so it is used only in the absence of seasonal trivalent influenza vaccines, following a link to ‘very rare’ cases of narcolepsy in young people.
A review of the risk-balance balance of the use of dronedarone in patients with atrial fibrillation is ongoing. The preliminary results of the PALLAS trial of Multaq, the brand name of dronedarone, was halted when evidence emerged the drug doubled the risk of death, stroke, and heart failure hospitalization in heart patients with permanent atrial fibrillation.