Other safety alerts
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| The United Kingdom: Naltrexone／bupropion (Mysimba▼): risk of adverse reactions that could affect ability to drive |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that naltrexone/bupropion has been associated with adverse reactions such as dizziness or somnolence, which can affect ability to drive, operate machinery, or perform dangerous tasks.
An EU review of cumulative data has identified somnolence as a common risk with naltrexone/bupropion and loss of consciousness as a rare risk. Given these and other adverse reactions, a new warning has been added to the product information that naltrexone/bupropion may affect the ability to drive, operate machinery, or perform dangerous tasks.
In a few cases, loss of consciousness occurred when the patient was driving, including a small number of cases worldwide associated with a road traffic accident. As of publication of this article, no adverse drug reaction reports for naltrexone/bupropion received through the UK Yellow Card Scheme have indicated a road traffic accident was associated with the reported event.
Patients should be advised not to drive, operate machinery, or perform dangerous activities while taking naltrexone/bupropion until they know how the medicine affects them. This should be considered especially just after starting or changing the dose of the medicine.
Healthcare professionals are advised:
- People taking naltrexone/bupropion may commonly experience dizziness or somnolence, and may rarely experience loss of consciousness or seizure.
- These effects would pose a risk to their ability to drive or operate machinery especially at the beginning of the treatment or during the dose titration phase.
- Advise patients experiencing adverse reactions with naltrexone/bupropion to not drive or operate machinery until they have resolved.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/naltrexone-bupropion-mysimba-risk-of-adverse-reactions-that-could-affect-ability-to-drive
In Hong Kong, there is no registered pharmaceutical product containing both naltrexone and bupropion.
Ends/Tuesday, Aug 20, 2019
Issued at HKT 16:00
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