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Warning of counterfeit ivermectin tablets sold via social media

The FAMHP and Sciensano are warning about counterfeit ivermectin tablets that are being used for self-medication against COVID-19. Investigations show that these counterfeit ivermectin tablets are systematically underdosed or seriously contaminated with bacteria. In 2021, a total of 12 529 counterfeit ivermectin tablets originating from postal packages were seized. These tablets are regularly found in postal packages to this day.

PRAC February 2024: reminder of serious adverse reactions when Paxlovid is taken in combination with certain immunosuppressants

During its February 2024 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency reminded healthcare professionals of the risk of serious and potentially fatal adverse reactions with Paxlovid when used in combination with certain immunosuppressants.

PRAC February 2023 – Start of a safety review of pseudoephedrine-containing medicines

During its February 2023 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has started a review of medicines containing pseudoephedrine.

Warning against the use of illegal TKTX ointment for tattoos

The FAMHP wants to warn consumers in Belgium about the use of TKTX ointment, an illegal pain-relieving cream and other illegal pain-relieving ointments containing lidocaine, prilocaine, epinephrine or a combination. These ointments are mainly used to relieve pain when applying a tattoo, permanent make-up ... TKTX ointment is not licensed in Belgium or Europe and therefore no guarantees can be given with regard to the composition, safety, quality or efficiency of this illegal medicine.

Genotoxic medicines and contraception: recommendations for all genotoxic active substances, regardless of therapeutic indication

The European Medicines Agency's Safety Working Party clarifies its recommendations on genotoxic medicines and the duration of contraception to apply to any genotoxic active substance, regardless of its therapeutic indication. However, the recommendations should not apply to active substances whose mechanism of genotoxicity is known to have a threshold which is not expected to be reached in patients. Marketing authorisation holders should take these new clarifications into account when considering the need to update their package leaflets.

Be careful of your pets when you use hormonal medicinal products on the skin.

In many European countries, side effects have been reported in pets whose owners use transdermal oestrogen-containing medicinal products. The pets came into contact with or licked the area where the medicinal product was applied, usually the upper arm.

Give your opinion on a genetically modified medicine for the treatment of Duchenne muscular dystrophy

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine SRP-9001 for the treatment of Duchenne muscular dystrophy. The public consultation runs from 17 January 2022 to 16 February 2022.

Warning against online sales of counterfeit medicine Seresto®, an anti-flea and anti-tick collar for cats and dogs

A counterfeit version of the medicine Seresto® collar for cats and dogs is being sold through Dutch online stores. The FAMHP warns against pet health hazards.

Limited availability of RoActemra (Roche): recommendations for (hospital) pharmacists, general practitioners and physician specialists.

The stock of RoActemra, a medicinal product used for certain rheumatological and haematological disorders, is currently limited worldwide. The Federal Agency for Medicines and Health Products (FAMHP) therefore issues recommendations.

PRAC June 2021 – EMA advises on Vaxzevria (COVID-19 Vaccine AstraZeneca) and update on ongoing evaluation of COVID-19 vaccines

During its June 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) advises against use of Vaxzevria in people with history of capillary leak syndrome. The PRAC is also continuing its assessment of reports of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) in a small number of people following vaccination with COVID-19 vaccines.

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