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Beware of painkillers during pregnancy
The Federal Institute for Drugs and Medical Devices (BfArM) is currently reporting on the basis of an opinion by the CHMP that metamizole-containing drugs should not be taken during pregnancy due to rare and serious side effects.
Pain reliever metamizole sodium
Metamizole sodium, or metamizole for short, is often used as an analgesic and antipyretic. The active substance from the group of non-acidic non-opioid analgesics is approved for the therapy of
acute and severe pain after injuries or operations, colic, tumor pain and other acute or chronic severe pain. The active ingredient is also used for high fever that does not respond to other measures.
Side effects of metamizole sodium
In contrast to other non-opioid pain relievers such as acetylsalicylic acid or diclofenac, metamizole is more stomach-compatible and gastric ulcers occur very rarely. However, there is still a slightly increased risk of gastrointestinal bleeding.
The opinion of the Committee for Medicinal Products for Human Use (CHMP) states that medicinal products containing metamizole should be contraindicated due to the risk of fetal kidney damage (fetal kidney damage) and a narrowing of the arterial duct in the third trimester of pregnancy. Appropriate changes to the technical and usage information should be made by the marketing authorization holder.
Spread of metamizole sodium
Because of the rare and serious side effect, metamizole was not approved in many industrialized countries, especially in the English-speaking world, but also in other areas such as Scandinavia and Japan, or an existing approval was revoked. In contrast, the use of prescription drugs is widespread in German-speaking countries.
Implementation of the opinion
With the current decision, the Federal Institute for Drugs and Medical Devices (BfArM) has implemented the relevant implementing decision of the European Commission (see here). This concludes the European risk assessment procedure under Article 31 of Directive 2001/83 / EC on "Metamizole sodium" and the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency is legally binding. (fm)