More than a month after popular anti-diabetes drug Pioglitazone was suspended in wake of possible health risks associated with it, the Union health ministry revoked the ban.
The health ministry issued a notification allowing the drug to be sold after the Drugs Technical Advisory Board (DTAB), government’s chief advisory body on Drugs that met in July, recommended the government to allow the marketing of the drug subject to certain conditions that the manufacturers shall mention on their package insert and promotional literature of the drug.
It has been recommended that the drug will not be used as a first line therapy for diabetes and the manufacturers should clearly mention the box warning in bold red letters, emphasising that patients with active bladder cancer or with the history of bladder cancer and those with uninvestigated haematuria should not receive Pioglitazone.
Also, those prescribing the drug should review the safety and efficacy of the drug in individuals after 3-6 months of treatment to ensure that only patients who are deriving benefits continue to be treated.
The experts also recommended that Pioglitazone should be stopped in patients who do not responded adequately to treatment (eg: reduction in glycosylated haemoglobin HbA1c).
The experts noted that before starting Pioglitazone 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.
For elderly patients, the experts opined that it should carefully be considered because the risk of bladder cancer increases with age.