Safety signal alerts from Pharmacovigilance Programme of India

The National Coordination Centre – Pharmacovigilance Programme of India (NCC-PvPI) has made a recommendation to the Central Drugs Standard Control
Organisation (CDSCO) to request that the patient information leaflet (PIL) for cardiac drug pentoxifylline, hypertension drug benidipine, respiratory infection drug piperacillin/tazobactum, enlarged-prostate drug alfuzosin and tinidazole should be revised to incorporate clinically significant adverse drug reaction.

These signals are identified based on individual case safety reports (ICSRs) received between July 2011 and November 2019 by NCC-PvPI.

Alfuzosin is used for the treatment of benign prostatic hyperplasia. A total of three ICSR of alfuzosin associated palpitations events are reported during this review period.

Benidipine is used for the treatment of hypertension and long term prophylactic management of angina pectoris. A total of five ICSRs received for benidipine associated photosensitivity reaction.

Pentoxifylline is a vasodilator indicated for the treatment of atrial and atriovenous circulatory disorder. A total of four ICSRs received for palpitations associated with pentoxifylline use.

Piperacillin/tazobactam is used for the treatment of moderate to severe lower respiratory tract infections. A total of six ICSRs received piperacillin/tazobactam
associated acute generalised exanthematous pustulosis (AGEP).

Tinidazole is used for the treatment of amoebiasis and giardiasis in adult patients only and in the treatment of anaerobic infections. A total of 13 ICSRs of tinidazole associated skin hyperpigmentation were received during review period.

All these cases were evaluated by the Signal Review Panel (SRP), PvPI, and Indian Pharmacopeia Commission (IPC) who found a strong causal relationship between drug and adverse drug reaction.

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.