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Pholcodine DHCP Letter

Pholcodine DHCP Letter

BOMRA has reviewed literature that associate pholcodine and perioperative anaphylaxis Data from a multicenter case-control study (ALPHO) comparing pholcodine exposure within a year before anesthesia between patients with NMBA-related POA (cases) and control patients with uneventful aesthesia was reviewed. The ALPHO has confirmed a significant association between pholcodine consumption in the year preceding NMBA exposure and NMBA-related POA (OR adjusted 4.2 CI 95% [2.5; 6.9]). Other environmental factors, including occupational exposure to quaternary ammonium, should be considered in the risk of NMBA-related anaphylaxis, but they currently remain poorly defined. The European Commission issued a legally binding decision applicable in all EU Member States to withdraw pholcodine containing products in March 2023. Subsequent to this a number of National Regulatory Authorities have removed Pholcodine from their markets and these include United Kingdom, Australia, Malaysia and South Africa.

Most vaccines are safe and well tolerated. However, if you experience any discomfort after vaccination, seek immediate medical attention and ask your healthcare provider to report the event to BoMRA

Botswana Medicines Regulatory Authority
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