The FAMHP monitors the market and guarantees the quality, safety and efficacy of medicinal products for all patients. To this end, the FAMHP is obliged to recall all batches of Marevan 60 tablets, manufactured by the firm Therabel, from pharmacies. The FAMHP issues recommendations to prescribers, pharmacists and patients.
Marevan is available in two packaging formats. Packages containing 60 tablets are recalled from the level of all pharmacies. This means that patients do not have to return their packages to pharmacies, but pharmacists can no longer supply new ones.
This measure does not concern the small package, Marevan 25 tablets, which can continue to be distributed and delivered. Nevertheless, the firm Therabel has reported a shortage of this format as of 20 October 2020. The firm only has a small emergency stock available.
Marevan (warfarin) is an anticoagulant. It is used to thin the blood in order to prevent the formation of clots (thrombosis) or to dissolve existing ones, thereby avoiding their migration into blood vessels (embolism). Given the risk of haemorrhages and/or blood clots when changing a Marevan-based treatment, the FAMHP makes recommendations to prescribers and pharmacists to offset the shortage.
- Should there be a shortage, the pharmacist can import an alternative pursuant to article 105 of the Royal Decree of 14 December 2006. A medical prescription and a declaration from the doctor are required to do so. Warfarin 5 mg is available abroad under the names Coumadin (Germany, France, Italy), Marevan (United Kingdom), Marevan Forte 5 mg (Finland), Panwarfine (Greece), Farin (Serbia) and Aldocumar (Spain).
- Regarding the change from warfarin to other anticoagulants (oral anticoagulants), the Belgian Centre for Pharmacotherapeutic Information (BCPI) published substitution schemes on 5 November 2019. These are still valid.
- Any change in treatment requires close monitoring of blood coagulation (INR monitoring), including the change from one product with warfarin to another with warfarin (e.g. imported) can disrupt coagulation.
The FAMHP is aware of the risks associated with the recall of Marevan 60 tablets, but the Agency cannot guarantee that the product meets the quality, safety and efficacy requirements. Protecting public health justifies this decision. As long as the verification of apparent infringements is ongoing, the FAMHP will not be able to provide further details on the recall.
The Agency is following the situation very closely and looking for other solutions to ensure the continuous availability of Marevan on the Belgian market, especially for patients with prosthetic heart valves for whom switching from one product to another is not a solution.