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Amsterdam, Netherlands – The European Medicines Agency (EMA) has concluded a review of the weight loss drug naltrexone/bupropion (Mysimba), reaffirming that its benefits continue to outweigh its risks for patients with obesity or overweight with comorbidities. However, the agency has acknowledged that the long-term cardiovascular safety of the drug, particularly beyond 12 months of use, remains uncertain.
Mysimba, authorized in 2015, is prescribed alongside diet and exercise for adults with a body mass index (BMI) of 30 kg/m² or higher, or those with a BMI between 27 and 30 kg/m² who also have conditions like type 2 diabetes, dyslipidemia, or controlled hypertension.
The recent review, initiated by the European Commission due to concerns about potential long-term cardiovascular risks, was conducted by the EMA’s Committee for Medicinal Products for Human Use (CHMP). While the CHMP concluded that the drug’s benefits still outweigh its risks, they emphasized that available data is insufficient to fully determine cardiovascular safety beyond 12 months of treatment.
“Studies to date have shown no cardiovascular safety concerns when the drug is used for up to 12 months. However, the data available are not sufficient to fully determine the cardiovascular safety beyond this time,” the EMA stated.
To address this uncertainty, the manufacturer has proposed an ongoing prospective, randomized, placebo-controlled study (INFORMUS) to evaluate long-term cardiovascular safety. Results from this trial are expected in 2028, and the EMA has made its completion a condition for continued marketing authorization, requiring annual progress reports.
Healthcare professionals are advised to discontinue Mysimba if there are concerns about safety or tolerability, including increased blood pressure. Annual patient reviews are also recommended to assess the drug’s continued benefit, considering any changes in cardiovascular risk and weight loss maintenance.
The EMA is updating product information and healthcare professional checklists to reflect these findings, and a letter outlining the recommendations will be distributed to relevant medical professionals.
The CHMP’s opinion will now be forwarded to the European Commission for a final, legally binding decision applicable across all EU member states.
Disclaimer: This news article is based on information provided by the European Medicines Agency (EMA). It is intended for informational purposes only and does not constitute medical advice. Patients should consult with their healthcare professionals before making any decisions related to their medical treatment. The information presented here should not be interpreted as an endorsement or recommendation of any specific drug or treatment. The long term cardiovascular safety of Mysimba remains uncertain and should be considered when prescribing or taking this medication.
