Mysimba Cardiovascular Risk and Annual Assessment Requirements
Summary
BfArM, in agreement with EMA, issued a Direct Healthcare Professional Communication regarding Mysimba (naltrexone/bupropion). The communication addresses long-term cardiovascular risks that have not been fully determined for patients treated beyond one year. New recommendations include discontinuation of treatment after one year if patients have not maintained at least 5% weight loss, and mandatory annual cardiovascular risk assessments for treatment continuation decisions.
What changed
BfArM issued new safety recommendations for Mysimba (naltrexone/bupropion) regarding long-term cardiovascular risk. Treatment should be discontinued after one year if patients have not maintained at least 5% weight loss from baseline. Physicians must conduct annual assessments to evaluate cardiovascular risk status and weight loss maintenance when considering treatment continuation.
Healthcare providers prescribing Mysimba should review current patients against the new criteria, implement annual monitoring protocols, and ensure patients are informed of cardiovascular risk uncertainties with extended treatment. Pharmaceutical manufacturers should update prescribing information and patient materials accordingly.
What to do next
- Conduct annual cardiovascular risk assessments for patients on continued Mysimba treatment
- Discontinue Mysimba treatment after one year if patient has not maintained at least 5% of initial body weight loss
- Inform patients about cardiovascular risk uncertainties with long-term use
Archived snapshot
Apr 12, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Direct Healthcare Professional Communication (DHCP) on Mysimba (naltrexone/bupropione): Long-term cardiovascular risk and new recommendations on annual assessment
2026.04.09
Active substance: naltrexon, bupropione
The marketing authorisation holder of Mysimba (naltrexone / bupropion), in agreement with the European Medicines Agency (EMA) and the German Federal Institute for Drugs and Medical Devices (BfArM), wish to inform that the cardiovascular risks of Mysimba in patients treated for longer than one year have not been fully determined, treatment with Mysimba should be discontinued after one year if a patient has not maintained a loss of at least 5% of their initial body weight when starting treatment with Mysimba as well as physicians should conduct an annual assessment when considering treatment continuation, to ensure no adverse change in cardiovascular risk and maintenance of weight loss.
To the risk assessment procedure
Mysimba Download DHPC/Information letter, DownloadVeroeffentlichtAmEN
2026.04.09
PDF, 276KB, File is accessible
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