IPC flags adverse reaction linked to popular COVID drug Remdesivir

New Delhi: The Indian Pharmacopoeia Commission (IPC), through its recently issued drug safety alert for the month of December, has revealed that popular Covid-19 drug Remdesivir is associated with Adverse Drug Reactions (ADRs) named Sinus Bradycardia.

This came after preliminary analysis of Adverse Drug Reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database.

Remdesivir is popular antiviral nucleotide analogue used for therapy of severe novel coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome (SARS) coronavirus 2 (CoV-2) infection.

Remdesivir is a direct-acting nucleotide prodrug inhibitor of the SARS-CoV-2 RNA-dependent RNA polymerase and it improves clinical outcomes in patients hospitalized with moderate-to-severe Covid-19 infection.

Remdesivir was originally granted FDA Emergency Use Authorization (EUA)15 on May 1, 2020, for use in adults and children with suspected or confirmed COVID-19 in a hospital setting with an SpO2 ≤94%.

Following the preliminary analysis of Adverse Drug Reactions (ADRs) from the PvPI database, it is reported that Remdesivir can lead to Adverse Drug Reactions (ADRs) known as Sinus Bradycardia.

Sinus bradycardia is a type of slow heartbeat. Normally, the SA node fires the signal at about 60 to 100 times per minute at rest. In sinus bradycardia, the node fires less than 60 times per minute.

Now, as per the issued drug safety alert, the following suspected drug is associated with the ADRs as given below:

In light of the above, the Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, has advised Healthcare Professionals, Patients/Consumers to closely monitor the possibility of the above ADRs associated with the use of above suspected drugs.

Further, the safety alert added, "If such reaction is encountered, please report to the NCC-PvPI, IPC by filling of Suspected Adverse Drug Reactions Reporting Form/Medicines Side Effect Reporting Form for Consumer (http://www.ipc.gov.in), through Android Mobile App "ADR PvPI App" and PvPIHelpline No. 1800-180-3024 (Toll Free)."