Pioglitazone back

As expected, the Indian government has revoked its suspension of the type 2 diabetes drug pioglitazone. However, it has stipulated that the agent should not be used as first-line treatment for diabetes and that it should carry a boxed warning relating to bladder cancer.

The decision to suspend the manufacture, sale, and distribution of pioglitazone in India, citing concerns over adverse effects, particularly bladder cancer, came out of the blue in June and was widely criticized by doctors and others there. In mid-July, however, a meeting of the drug technical advisory board (DTAB) recommended that pioglitazone be put back on the market.

Now, the Ministry of Health and Family Welfare has announced that all formulations containing pioglitazone for human use are allowed to be manufactured, sold, and distributed once again, albeit with warnings on the package insert.

The new warnings, which must be listed on pioglitazone formulations in India, will state that patients with active bladder cancer or with a history of bladder cancer and those with uninvestigated hematuria should not receive pioglitazone.

And before starting the drug, individuals should be assessed for known risk factors for bladder cancer, including age, smoking history, exposure to occupational or chemotherapy agents, or previous irradiation of the pelvic region.

Prescribers should also review the use of the agent after 3 to 6 months to ensure that only patients who are deriving benefit from it continue to be treated. 

Pioglitazone should be stopped in patients who do not respond adequately to treatment.

There is also special advice for the use of pioglitazone in elderly patients, which "should be considered carefully before and during treatment because the risk of bladder cancer increases with age." Elderly patients should start on the lowest possible dose "and be regularly monitored because of the risks of bladder cancer and heart failure associated with pioglitazone." (Medscape)