New Delhi: The Narendra Modi government’s expert drug panel has asked the country’s apex health regulatory body to add the newly found side-effects of cardiac and prostate disease drugs in their pack inserts.
Cardiac drug pentoxifylline, hypertension drug benidipine and enlarged-prostate drug alfuzosin have been found to cause palpitation and sensitivity to ultraviolet (UV) rays from the sun and other light sources, according to the minutes of a meeting held by the panel earlier this month.
The Subject Expert Committee (SEC) has asked the Central Drugs Standard Control Organisation (CDSCO) to request state drugs controllers to direct manufacturers to list the side-effects on pack inserts.
The CDSCO is the health ministry arm that regulates the quality of drugs and vaccines in India.
The move is based on the recommendations of the Signal Review Panel-Pharmacovigilance Programme of India (SRP-PvPI), which is responsible for the continuous detection, assessment and prevention of adverse effects to assess the safety of medicines sold in the country.
The SEC advises the country’s drug regulator, Drug Controller General of India (DCGI), on important matters, including new drug and vaccine approvals and addition of side-effects to lists.
What the panel has said
The SEC has advised that ‘palpitation’ be added as an adverse reaction in the pack-insert literature (PIL) for pentoxifylline. The drug is used to improve blood flow in patients with blood circulation problems in the hands and feet.
The pack inserts for alfuzosin should also list ‘palpitation’ as a side-effect, the panel states.
The side-effects of benidipine include photosensitivity, which is an adverse skin reaction to sun exposure.
The panel has also recommended that the CDSCO obtain the details about the total number of patients treated with alfuzosin and benidipine. It has also asked the CDSCO to ascertain who is consuming these drugs, and how many people have reported palpitation and photosensitivity, respectively.