Regional Pharmacovigilance Center

April 2025 - Although metamizole-induced agranulocytosis (AIM), which can lead to serious or fatal infections, is a very rare side effect (1 in 10,000 people), the number of reports of AIM in Switzerland over the past decade has nearly tripled in parallel with the doubling of Swiss sales figures for drugs containing metamizole. The number of fatal AIMs has remained stable.
Therefore, a so-called "Boxed warning" aimed at minimizing the risk of agranulocytosis, containing the following warnings, will be introduced for all drugs containing metamizole:
- AIM is an idiosyncratic, nondose-dependent side effect and can occur at any time during treatment, even immediately after its discontinuation and even if the drug has been used previously without complications.
- If the drug is taken for fever, some symptoms of agranulocytosis may go unnoticed, just as concomitant antibiotic therapy may mask the symptoms. If suspected, a complete blood count (including differentiation) should be performed immediately, and treatment should be stopped immediately.
- Fatal cases of AIM reported in the pharmacovigilance database often included metamizole in combination with methotrexate. Since this combination may potentiate hematotoxicity (particularly in the elderly) the concomitant use of the two drugs should be avoided.
It should also be remembered that methamizole is not a first-choice drug. It is registered in Switzerland for the treatment of severe pain and fever that do not respond to other therapies. Use outside these indications is considered off-label and requires the consent of the patient(s).

April 2025 - Although metamizole-induced agranulocytosis (AIM), which can lead to serious or fatal infections, is a very rare side effect (1 in 10,000 people), the number of reports of AIM in Switzerland over the past decade has nearly tripled in parallel with the doubling of Swiss sales figures for drugs containing metamizole. The number of fatal AIMs has remained stable.
Therefore, a so-called "Boxed warning" aimed at minimizing the risk of agranulocytosis, containing the following warnings, will be introduced for all drugs containing metamizole:
- AIM is an idiosyncratic, nondose-dependent side effect and can occur at any time during treatment, even immediately after its discontinuation and even if the drug has been used previously without complications.
- If the drug is taken for fever, some symptoms of agranulocytosis may go unnoticed, just as concomitant antibiotic therapy may mask the symptoms. If suspected, a complete blood count (including differentiation) should be performed immediately, and treatment should be stopped immediately.
- Fatal cases of AIM reported in the pharmacovigilance database often included metamizole in combination with methotrexate. Since this combination may potentiate hematotoxicity (particularly in the elderly) the concomitant use of the two drugs should be avoided.
It should also be remembered that methamizole is not a first-choice drug. It is registered in Switzerland for the treatment of severe pain and fever that do not respond to other therapies. Use outside these indications is considered off-label and requires the consent of the patient(s).

May 2024 - Following a reevaluation of the benefit/risk ratio, the indication of tolperisone-containing drugs has been limited to the treatment of spasticity associated with cerebrospinal lesions in adults, as only in this indication do the benefits of treatment outweigh the possible risks, including even hypersensitivity reactions up to anaphylactic reactions/anaphylactic shock.
Tolperisone is therefore no longer indicated for the treatment of muscle spasms in pain of musculoskeletal origin.

May 2024 - Following a reevaluation of the benefit/risk ratio, the indication of tolperisone-containing drugs has been limited to the treatment of spasticity associated with cerebrospinal lesions in adults, as only in this indication do the benefits of treatment outweigh the possible risks, including even hypersensitivity reactions up to anaphylactic reactions/anaphylactic shock.
Tolperisone is therefore no longer indicated for the treatment of muscle spasms in pain of musculoskeletal origin.

April 2024 - Pseudoephedrine is approved, alone or in combination with other active ingredients, for the treatment of cold and flu symptoms, allergic rhinitis, or vasomotor rhinitis in cases of nasal congestion. Cases of reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) related to taking pseudoephedrine-containing medicines have been reported.
Pseudoephedrine-containing medicines should not be used in patients with severe or poorly controlled hypertension, renal disease, or severe renal insufficiency, as these conditions increase the risk of PRES and RCVS.

March 2024 - Results of a retrospective observational study indicate an increased risk of neurodevelopmental disorders in children (aged 0-11 years) born to fathers treated with valproate in the three months before conception and/or at the time of conception itself, compared with those treated with lamotrigine or levetiracetam. In the absence of alternative treatment options, effective contraception is recommended for them and their partners in male reproductive-age patients throughout valproate treatment and for 3 months after discontinuation of therapy.

March 2024 - In addition to the known risk of severe congenital malformations and fetal growth restriction when used in pregnancy, recent data from two epidemiological studies also indicate a possible increased risk of neurodevelopmental disorders (autism spectrum disorders, intellectual disability intellectual and attention deficit hyperactivity disorder) 2 to 3 times higher in children of mothers with epilepsy exposed in utero to topiramate, compared with children of mothers with epilepsy not exposed to an antiepileptic. For migraine prophylaxis, topiramate is therefore contraindicated in pregnancy and in women of childbearing age who are not using highly effective contraceptive methods. For the treatment of epilepsy, it is contraindicated in pregnancy and in women of childbearing age who are not using highly effective contraceptive methods, unless there is a suitable alternative treatment. Because of potential interactions, women using systemic hormonal contraceptives should also be advised to use a barrier contraceptive method.

February 2023 - In February 2023, approval holders of drugs belonging to the Janus kinase inhibitor (JAK) class: abrocitinib (Cibinqo®), baricitinib (Olumiant®), upadacitinib (Rinvoq®), and tofacitinib (Xeljanz®), report an increased risk of cancer disease (particularly lung cancer, lymphoma, and non-melanoma skin cancer), serious cardiovascular events, serious infections, thrombosis/embolism, and mortality overall in patients treated with these drugs, compared with patients treated with tumor necrosis factor (TNF) inhibitors. These risks are considered class effects and affect all JAK inhibitors approved for chronic inflammatory and dermatologic diseases. Therefore, in patients ≥65 years of age who are smokers or former smokers or have other risk factors for malignancies/cardiovascular disease, JAK inhibitors should be used only when suitable therapeutic alternatives are not available.

February 2023 - The concentration of propylene glycol during the use of Becetamol® drops (acetaminophen) at the recommended daily dosage exceeds the threshold values accepted as safe by several times, especially in infants and young children. Because of the possible health risks, Becetamol® drops should therefore no longer be used in infants and children under the age of 5 years. The approval holder has therefore waived further approval of the product from February 2023 (EXP of the last batch: 11/2023).