IPC flags safety alert against Covid-19 drug Remdesivir

These companies received technology transfers of the Gilead manufacturing process and scaled up production

Indian Pharmacopoeia Commission IPC

Last Updated on December 26, 2023 by The Health Master

The Indian Pharmacopoeia Commission (IPC), which is the National Coordination Center (NCC) for the Pharmacovigilance Program of India (PvPI), has flagged a drug safety alert revealing that the Covid-19 drug remdesivir is linked with an adverse event known as sinus bradycardia.

This came to light after the preliminary analysis of adverse drug reactions (ADRs) from the PvPI database.

Remdesivir is a broad-spectrum antiviral medication developed by the biopharmaceutical company Gilead Sciences.

It is a novel nucleoside analog with a broad antiviral activity spectrum among RNA viruses, including ebolavirus (EBOV) and the respiratory pathogens Middle East respiratory syndrome coronavirus (MERS-CoV), SARS-CoV, and SARS-CoV-2.

Studies showed that remdesivir reduces the time to recovery in patients with Covid-19, leading to an emergency-use authorization (EUA) by the US Food and Drug Administration (FDA) on May 1, 2020.

The Central Drugs Standard Control Organization had approved restricted emergency use of remdesivir injectable formulations for treatment of patients with severe Covid-19 infection in June 2020.

On 3 July, 2020 the European Medicines Agency (EMA) granted a conditional marketing authorization for remdesivir, which was the first approved antiviral treatment against Covid-19.

Remdesivir is currently approved in 50 countries as a treatment for patients infected with SARS-CoV-2, the virus that causes Covid-19.

Gilead Sciences has signed non-exclusive licensing agreements with several generic drug makers in India, including Cipla, Hetero Labs, Jubilant LifeSciences, Mylan, Zydus Cadila, and Dr. Reddy’s Laboratories, to expand the supply of remdesivir.

Following the licensing agreement, these companies received technology transfers of the Gilead manufacturing process and scaled up production.

As per a drug safety alert issued by IPC in the last week of December 2021, remdesivir is associated with sinus bradycardia, which is a type of slow heartbeat. A special group of cells begins the signal to start one’s heartbeat.

These cells are in the sinoatrial (SA) node. Normally, the SA node fires the signal about 60 to 100 times per minute at rest. In sinus bradycardia, the node fires less than 60 times per minute.

Healthcare professionals and patients have been advised to closely monitor the possibility of the above ADR associated with the use of remdesivir. If such a reaction is encountered, it needs to be reported to the NCC-PvPI for suitable action.

IPC had earlier also flagged drug safety alerts revealing that diclofenac, a nonsteroidal anti-inflammatory drug (NSAID) which is used to treat pain and inflammatory diseases, is linked with skin hyperpigmentation while dimethyl fumarate, which is indicated for relapsing-remitting multiple sclerosis, is associated with adverse drug reaction alopecia.

Cefazolin, a cephalosporin antibiotic is linked with acute generalised exanthematous pustulosis (AGEP), according to the preliminary analysis of ADRs from the PvPI database.

Besides this, it had earlier also flagged drug safety alerts revealing that clobazam, baclofen and rosuvastatin and ticagrelor interactions are associated with risks like DRESS syndrome, encephalopathy and rhabdomyolysis respectively.

The CDSCO started PvPI in July 2010 across the country. Since then, IPC has been mandated to establish clinical evidence linking the drug and the ADR event thru a robust system of causality assessment.

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