Less than a month after popular anti-diabetes drug pioglitazone and painkiller analgin were suspended in wake of possible health risks associated with them, the Drugs Technical Advisory Board (DTAB), government’s chief advisory body on drugs that met Friday, decided to revoke the ban.
Sources disclosed that it was decided that pioglitazone be sold with a “boxed warning” emphasising that its use for over a year may be associated with an increased risk of bladder cancer. The experts also suggested that a medication guide be inserted in the pack that carry riders on the dose and duration of the treatment. “The doctors will have to be careful and should review the patients taking the drug every six months. The drug should be cautiously prescribed for old age. The guide should also carry warnings like minimum dose to be prescribed etc,” a source added.
So far only France had taken pioglitazone of the shelves. Significantly, the decision to suspend the sale of the drug in India was taken following information from some doctors that noticed adverse event reports due to its use.
One such letter from Chennai-based diabetologist to Prime Minister Manmohan Singh and health minister Ghulam Nabi Azad sent alarm bells ringing, so much so that it was decided to suspend the sale of the drugs without even discussing it with the DTAB — the highest decision-making body on such cases.
The “sudden and abrupt” suspension of the drug in India last month had even disappointed the medical experts. However, as reported by this newspaper first, the Drug Controller General of India (DCGI) had decided to take a positive view on the drug after the diabtologists expressed their apprehensions on the decision to suspend the drug.
Leading experts had met the Drug Controller General of India (DCGI) and the Director-General Health Services (DGHS) on July 11, suggesting that the ban should be revoked.
The drug is sold in US with a boxed warning. Fortis-C-DOC Centre of Excellence for Diabetes and Metabolic Diseases Chairman Anoop Misra said, “If the government revokes the ban, it is going to commendable and progressive step since we need this low cost effective drug for India. However, physicians and patients should be educated regarding its adverse drug reactions,” he said.
Sources said that the ban from Analgin was revoked as there was not much evidence suggesting its adverse effects. “Analgin is a second line drug and is taken occasionally. So far it has not been banned in any other country except France. The experts opined that there was not much evidence suggesting its bad effects on the human body therefore it was decided to revoke the ban.