The European Medicines Agency (EMA) is currently modifying its recommendations to reduce the risks associated with interactions between the weight loss medication Mysimba (naltrexone/bupropion) and opioids. These revisions are the result of a re-evaluation of earlier studies and are intended to address safety concerns about the use of Mysimba in conjunction with opioids.

Mysimba, a medicine used in conjunction with diet and exercise to address obesity or overweight disorders with associated comorbidities, contains naltrexone, an opioid antagonist. This combination can make opioid drugs, such as morphine and codeine, less effective. Furthermore, patients taking Mysimba in conjunction with opioids and serotonergic antidepressants have documented significant and sometimes fatal adverse effects, including seizures and serotonin syndrome.

To avoid these hazards, the EMA recommends tight guidelines. Patients taking Mysimba are advised not to use it if they are opioid dependent, receiving opioid addiction treatment such as methadone or buprenorphine, or experiencing acute opioid withdrawal. Healthcare practitioners should encourage patients to stop using Mysimba at least three days before scheduled procedures that often involve opioids.

Mysimba's product information is being revised, and each container of medicine will now include a patient card. This card serves as a reminder to alert healthcare practitioners about Mysimba use, particularly before surgery. 

Stakeholders and specialists are participating in the PRAC's reassessment of data on these exchanges. "Introducing a patient card is a significant step forward in promoting patient safety,"said one participant adding that patients and doctors must stay informed to prevent potentially severe consequences.

Mysimba's marketing and safety guidelines, initially approved in 2015, are currently undergoing revision by the Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Medicinal Products for Human Use (CHMP). These groups are agreeing on strategies to reduce the risks of inadequate opioid analgesia and associated problems. 

Healthcare professionals welcome the updated measures. "The inclusion of explicit warnings and procedural guidelines will significantly reduce risks during emergency or planned surgeries," according to an EMA spokesman. 

The European Commission said that it will now receive the CHMP's approval of the PRAC's recommendations and make a final decision that will apply to all EU Member States asking  patients and healthcare professionals to strictly adhere to the amended instructions to ensure their safety.