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The EMA warns of the risks of using the slimming drug Mysimba in combination with opioid medicines

Misimba It is a medication, in combination with diet and exercise, to manage weight in adults who are overweight (with a body mass index (BMI) of 30 or more) or obese (with a BMI between 27 and 30) and have weight-related problems – diabetes, abnormally high blood fat levels or high blood pressure. Mysimba received marketing authorization on 26 March 2015.

After a standard safety assessment of the slimming medicine Mysimba (which contains the active substances naltrexone / bupropion), the EMA recommends strengthening the existing recommendations to reduce the risks that may arise from interactions between the medicine Mysimba and medicines containing opioids (including reducing such pain relief). such as morphine and codeine, other opioids used during surgery and some cough, cold or diarrhea medicines).

In particular, the EMA warns that opioid pain medications may not work effectively in patients treated with Mysimba, because one of its active ingredients, naltrexone, blocks the effects of opioid medications. If a patient needs opioid drug treatment while on Mysimba, for example because of a planned operation, they must therefore stop taking Mysimba for at least three days before starting opioid drug treatment.

In addition, the EMA informs patients and healthcare professionals about the risk of rare but serious and potentially life-threatening reactions such as convulsions and serotonin syndrome (a condition that can be life-threatening due to excess serotonin in the body), in patients taking Mysimba together. with opioid medications.

To reduce these risks, the EMA recommends that Mysimba should not be used by people who are being treated with opioid medicines.

This recommendation is in addition to the existing contraindications that Mysimba should not be used by people with long-term opioid dependence (on chronic opioid treatment), who are receiving opioid agonist treatment such as methadone, and which withdraw, after they have been used. opioids.

Information for patients:

The weight loss medicine Mysimba is known to block the effects of opioid medicines (pain relievers such as morphine and codeine, other opioid medicines used in surgery and some medicines for coughs, colds or ‘ diarrhea). The result could be a reduced effect of opioid drugs used during and after surgery as part of anesthesia and pain management.

If you are having any surgery, tell your doctor that you are using Mysimba. Your doctor may advise you to stop taking this medicine at least three days before the procedure.

Rare but serious side effects, including seizures and serotonin syndrome (a potentially life-threatening condition caused by too much serotonin in the body) have also been reported in patients taking Mysimba. in combination with opioid medications.

Because of the risk of these side effects, you should not use Mysimba if you are being treated with opioid medications, are dependent on opioid medications, are being treated with opioid agonists such as methadone, or if you going through acute opioid withdrawal.

Source: ANM

2024-08-27 13:31:42
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