Health ministry revokes suspension notification against diabetes drug, pioglitazone
02 August 2013
The health ministry has withdrawn the suspension notification of diabetes drug, pioglitazone, and has allowed its manufacture and prescription of its formulations, with riders however, including a box warning in ''bold red letters'' to caution patients.
The move comes about a month after the ministry suspending the sale and distribution of the drug for its links to urinary bladder cancer.
The suspension was totally unexpected which led to loud protests by doctors, patients and drug companies as also submissions to the ministry. According to doctors, the drug was best suited for Indian patients.
The notification came came laced with much caution and according to the health ministry, it was aware that the drug was risky and safer alternatives were available. It however, proceeded to say that the Drugs Technical Advisory Board recommended the revocation of the suspension of pioglitazone, with certain conditions, which included that the manufacturers carry warnings on the packing, product insert and promotional literature.
The notification added the drug needed not to be used as a first line of therapy in the treatment of diabetes. Besides carrying the warning in bold red letters it would also carry advice for healthcare professionals, the notification said.
According to the notification dated 31 July issued by the union government, the drug would not form first line of therapy for diabetes and the warning would need to be clearly mentioned on the box 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 would read: ''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)'' according to the notification.
'' 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.