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Drug Safety Update

1 Crown Copyright 2022 Drug Safety Update Latest advice for medicines users The monthly newsletter from the Medicines and Healthcare products Regulatory Agency and its independent advisor the Commission on Human Medicines Volume 15 Issue 7 February 2022 Contents COVID-19 antivirals: reporting to the UK COVID-19 Antivirals Pregnancy Registry page 2 Hydroxychloroquine, chloroquine: increased risk of cardiovascular events when used with macrolide antibiotics; reminder of psychiatric reactions page 5 Ivacaftor, tezacaftor, elexacaftor (Kaftrio ) in combination with ivacaftor (Kalydeco): risk of serious liver injury; updated advice on liver function testing page 9 COVID-19 vaccines and medicines: updates for February 2022 page 12 Letters and medicine recalls sent to healthcare professionals in January 2022 page 13 The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency responsible for ensuring that medicines and medical devices work and are acceptably safe.

safety, quality, and efficacy of medicines. The Commission is supported in its work by Expert Advisory Groups that cover various therapeutic areas of medicine. during Kaftrio NICE has accredited the process used by the MHRA to produce Drug Safety Update guidance. More information on accreditation can be viewed on the NICE website.

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