Healthcare institutions across the country are in the process of reviewing and closely monitoring diabetic patients who are under medication of anti-diabetic drug pioglitazone for ascertaining whether its regular intake can cause bladder cancer.

This review is part of the union health ministry’s mandate to determine the relationship between a serious adverse event and the drug in question for scientifically validating the claims through an intensive adverse drug reaction (ADR) monitoring exercise.

The intensive ADR monitoring exercise started recently across the country is based on the health ministry’s guidelines and protocols shared with around 35 healthcare institutions of repute.

“The study on patients having pioglitazone has been encouraged at specific centres which are competent to do the same. The centres are supposed to closely monitor patients under pioglitazone medication over a period of at least one year as per the mandated protocol to generate clinical evidence between drug and adverse side effects, if any,” according to an official associated with the development.

There are complicated and controversial aspects against pioglitazone and its urinary bladder cancer. In June 18, 2013, Indian government suspended pioglitazone over safety concerns only to revoke the suspension on July 31, 2013. The oral hypoglycemic drug, which has been linked to urinary bladder cancer, is back in the Indian market with warnings.

The link between bladder cancer and pioglitazone first appeared in preclinical studies in the US in 1999 and has now been reported in human clinical studies also.

Health ministry’s Drugs Technical Advisory Board (DTAB) recommended the revocation of the suspension of pioglitazone on the condition that the manufacturers carry warnings on the packing including a box warning in bold red letters, product insert and promotional literature, government notification stated.

Further, it added, that the drug not be given to patients with a history of bladder cancer, be restricted to the elderly and prescribed after knowing the patient’s history. Those prescribed with the drug would also be put through six monthly reviews and under pharmacovigilance, the notification added.

Now, the union health ministry has also asked adverse drug reaction monitoring centres (AMCs) to set up causality assessment committee in each of the 250 AMCs functioning across the country.

This is urgently required as this will effectively help in establishing clinical evidence between the drug and adverse drug reaction or serious adverse event associated with it in the patient.

Indian Pharmacopoeia Commission (IPC) functioning under the union health ministry has recently come out with draft protocol and guidelines focused on targeted drugs and events as a part of Intensive adverse drug reaction monitoring exercise under Pharamacovigilance Programme of India (PvPI) so that appropriate action can be taken on specific drugs involving adverse events or reactions.