To enable safe and effective usage of Cladribine, MHRA released a drug safety update to healthcare professionals and patient/patient care providers to consider the below risk minimizing measures for the serious risk of liver injury.

Cladribine is a synthetic purine nucleoside with immunosuppressive effects used in the treatment of highly active relapsing multiple sclerosis. Review of recent safety data identified 16 case reports pertaining to this drug-adverse drug reaction (ADR) pair: Cladribine-serious liver injury. Of 16 cases, one fatal outcome reported in a patient with concurrent alcohol-related liver disease. In one case, no alternative causes were identified. In most of the reported cases, time to onset was < 8 weeks. No plausible mechanism was identified for this drug-ADR pair. Owing to the potential serious risk of liver injury in susceptible patients, MHRA and Product’s manufacturer released a direct healthcare professional communication (DHPC) letter for safe & effective use of this medicine.

A summary of DHPC letter important of healthcare professionals and patient/patient care providers is presented below:

Relevant Medical History Check: Before starting treatment with cladribine, a detailed patient history of underlying liver disorders or episodes of liver injury with other medicines should be undertaken.

Liver screening test before treatment: Liver function tests including serum aminotransferase (alanine aminotranferase ALT & aspartate aminotransferase AST), alkaline phosphatase, and total bilirubin levels should be assessed prior to initiation of therapy in year 1 and year 2.

Liver screening test during treatment: Liver function tests should be conducted, and repeated as necessary during the period of treatment as well.

Proactive Measure/Action: In case a patient develops any sign/symptoms of liver injury, treatment with cladribine should be interrupted or discontinued, as appropriate.

Voluntary ADR reporting:

Every medicinal product has both benefits and risks. Medicines are authorized to market based on the favorable benefit-risk profile anticipated at the time of regulatory approval/entry into market. However, the safety profile of medicine would continuously updates owing to the emerging safety data from the post marketing experience from public. If the rate of reporting of suspected adverse drug reactions (ADR) from public is line with the actual occurrence of ADRs, the time lapse for taking regulatory action can be reduced and thereby improving patient safety.

All health care professionals and consumers of pharmaceutical medicinal products are encouraged to be aware of this fact and observe/monitor for any possible adverse events, reactions, medication errors, or quality complaints of medicinal products and report the same to your respective national health authority.

This would accumulate safety evidence for medicinal products which in turn help health authorities to take regulatory actions at the earliest possibility for a better patient safety and overall public health.

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