Following critical evaluation on the use of ranitidine associated with cardiac arrest as per Individual Case Study Reports (ICSRs), the signal review panel (SRP) recently submitted a high level recommendation to the CDSCO suggesting label change of the following medicinal product. They recommended CDSCO to instruct manufacturers and concerned marketing authorisation holders (MAHs) to add the above adverse drug reaction in their package insert.

This move comes in the wake of observation made by the SRP that as per three Indian case reports published in different journals, ranitidine was associated with cardiac arrest. Since the case was considered to be having immense public impact, it was put forward to the chair.

Based on the critical evaluation on this drug-ADR combination, it was concluded that the causal relationship between intravenous ranitidine and cardiac arrest can be established but, no association can be established with effervescent tablet with available data. Dr V Kalaiselvan, principal scientific officer, Indian Pharmacopoeia Commission, informed that in lieu of this, all the cases were evaluated and it was observed that all the literature case reports were of intravenous ranitidine whereas ICSRs received was of effervescent tablet.

Dr Kalaiselvan informed, “We have already put forth our recommendations to the CDSCO to make the requisite label changes following this study. However, now it is up to the CDSCO to take the final call on this matter on whether cautionary label should be incorporated in the Indian package insert of marketed ranitidine IV medicinal products or not.”

Currently, the product labeling information of ranitidine that is marketed in UK mentions, ‘other H2 receptor antagonists bradycardia, AV-block and, injection only’.

Apart from this, the sixth signal review panel meeting also recommended adding following information about drugs and their side effects to the CDSCO. Based on their observation from two ICSRs for anti-rabies vaccines (rabipur) induced erythema multiforme reported from the same AMC, along with one case report published in Pediatric Dermatology Journal, from UCMS- GTB hospital, the SRP concluded that there was a strong temporal relationship between the anti rabies vaccines and the ADR i.e. erythema multiforme. Based on this the SRP has recommended the CDSCO to incorporate this warning in package inserts of suspected drug marketed domestically.

Similarly, the SRP also recommended the Centre to check and insert domestic patient information (PI) leaflet on surfactant based drugs on possible ADR combination about surfactant induced pulmonary haemorrhage. This is based on the review of all ICSRs of surfactant and pulmonary haemorrhage received by NCC- PvPI.