Nearly one and half month after suspending the manufacturing and sale of anti-diabetes drug pioglitazone that led to widespread protests in the industry, the Union Government has now revoked the suspension and allowed it to be marketed with box warning as recommended by the Drugs Technical Advisory Board.

According to the notification dated July 31 by the Union Government, the drug should not be used as first line of therapy for diabetes and the manufacturer should clearly mention box warning in bold red letters.

“Pioglitazone and all formulations containing pioglitazone for human use is allowed to be manufactured for sale, sale and distribution subject to the condition that the manufacturers shall mention the following on their package insert and promotional literature of the drug,” the notification said.

The advice for healthcare professionals on the package will read as: “patients with active bladder cancer or with a history of bladder cancer and those with uninvestigated haematuria should not receive pioglitazone. Prescribers should review the safety and efficacy of pioglitazone in individuals after 3-6 months of treatment to ensure that only patients who are deriving benefit continue to be treated. Pioglitazone should be stopped in patients who do not respond adequately to treatment (eg, reduction in glycosylated haemoglobin, HbA1c)” the notification said.

“ Before starting pioglitazone, the following known risk factors for development of bladder cancer should be assessed in individuals: age, current or past history of smoking, exposure to some occupational or chemotherapy agents such us cyclophosphamide, or previous irradiation of the pelvic region. Use in elder patients 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,” it said.

Through a notification dated June 18, 2013, the Government had suspended the manufacture of pioglitazone and all formulations containing pioglitazone for human use, under Section 26A of the Drugs and Cosmetic Act, 1940.

The government notification said the DTAB had examined the issue of suspension on july 19 and recommended that the suspension be revoked and allowed it to be marked subject to certain conditions the manufacturers shall mention on their package insert and promotional literature of the drug. Accordingly, the action has now been initiated.