Other safety alerts
|
| |
| European Union: EMA recommends aligning doses of metamizole medicines and their use during pregnancy and breastfeeding |
| |
European Medicines Agency (EMA), following a review of medicines containing the painkiller metamizole, is recommending that the maximum daily dose of the medicine and the contraindications to its use in pregnancy or women who are breastfeeding should be harmonised for all products on the European Union (EU) market. The recommendation addresses inconsistencies in the product information for metamizole medicines, which are marketed in many EU member states to treat severe pain and fever that cannot be controlled with other treatments.
The review was carried out by EMA’s human medicines committee (CHMP) at the request of Poland, which was concerned by the substantial differences in the recommendations on the use of metamizole in different EU countries, given that it is known the medicine may occasionally cause severe side effects, such as effects on the blood. The Agency reviewed the available information on the way the medicine is distributed in the body, how it works and the limited data on its effects on the unborn child or breast-fed infant.
EMA’s recommendations include setting a maximum single dose by mouth of 1,000 mg, taken up to 4 times daily (a maximum daily dose of 4,000 mg), in patients from 15 years of age. Treatment should start at the lowest recommended dose and only be increased if needed. If given by injection the total daily dose should not exceed 5,000 mg. Doses in younger patients should be based on their body weight but some products may be unsuitable because of their strength.
Although metamizole has been on the market for nearly a century, evidence of its effects in pregnancy and breastfeeding is scarce. The review found little to suggest problems in early pregnancy, and single doses in the first 6 months might be acceptable if other analgesics cannot be used. However, there is some evidence of effects on the kidneys and circulation of the fetus if the medicine is used in the last 3 months of pregnancy, and the medicine should therefore not be used in this period. As a precaution, metamizole should not be used during breastfeeding because the infant may receive high amounts of the medicine in the milk relative to the infant’s weight.
EMA has recommended changes to the product information of metamizole, to ensure that advice on the maximum daily doses and warnings not to use the medicine during the last 3 months of pregnancy or during breastfeeding are consistent across the EU.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/medicines/../metamizole-containing-medicinal-products
In Hong Kong, there are 2 registered pharmaceutical products containing metamizole (also known as noramidopyrine methanesulphonate in Hong Kong) which are Sulpyrin Inj 25% (HK-02899) and Olan-gin (With Lidocaine HCL) Inj 1g/2ml (HK-16283). Both products are prescription-only medicines. So far, the Department of Health has not received any case of adverse drug reaction related to metamizole. In light of the above EMA’s announcement, letters to inform local healthcare professionals will be issued and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Monday, Dec 17, 2018
Issued at HKT 16:00
|
| |
|
