Risk of life through Promethazin: New warning notices must be observed!

Risk of life through Promethazin: New warning notices must be observed!

In a current message, the European Medicines Agency (EMA) and the coordination group for the procedure of human medicinal products (CMDH) warn of the serious risks of the Promethazin drug. This tightening of the safety instructions is due to collected reports on dangerous side effects.

Promethazin, which is used to relieve allergies, nausea, as well as in sleep disorders and inner unrest, belongs to the group of H1 antihistamines of the first generation. It was found that the risks of the drug, including potentially fatal malignant neuroleptic syndrome, can overlap therapeutic benefits. Symptoms such as muscle stiffness, high fever and blood pressure fluctuations can be expected. Deadly cardiac arrhythmia can occur in the event of overdose.

special caution in those affected

Patients with existing heart problems or irregular cardiac arrhythms are particularly at risk. Certain combinations with other drugs, such as neuroleptics or certain antibiotics, also increase the risk of serious side effects. In order to minimize the risk of changes in blood count, in particular thrombocytopenia and the associated dangerous bleeding, the Federal Institute for Medicines and Medical Devices (BfArM) emphasized that no positive benefit-risk relationship can be assumed without the new warnings.

The revised product information for Promhazine-containing medicines apply to both specialist groups and patients and are particularly relevant in systemic use (tables, drops, infusions). Despite these risks, the drug remains on the market, but under strict requirements. A medical advice should always be obtained before taking it, especially for people with heart problems or a variety of other medication that they take.

Risk reviews and medical recommendations

Current reviews show that the risks of the drug can exceed the advantages, which the EMA and CMDH have also recognized. The committee for risk assessment in pharmacovigilance (PRAC) has confirmed the indications of dangerous side effects, including malignant neuroleptic syndrome and severe cardiac arrhythmias. In the event of signs such as sudden muscle stiffness or heart problems, medical help should be sought immediately.

The discussion about Promethazin illustrates a general problem in drug therapy: H1 antihistamines of the first generation, which includes Promethazine, are increasingly being replaced by non-sedating alternatives. The safety of these drugs continuously stands for monitoring and evaluation at national and international level to ensure the health of the patient.

For more information about the risks and secure applications of H1-antihistamines and on specific warnings, please visit the pages of t-online and bfarm .