Other safety alerts
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| European Union: EMA updated advice to minimise risks of interaction between weight loss medicine Mysimba and opioids |
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European Medicines Agency (EMA) announces after re-examining its initial opinion, EMA recommends updating the advice aimed at minimising the risks of interaction between the weight loss medicine Mysimba (naltrexone/bupropion) and opioid-containing medicines (including painkillers such as morphine and codeine, other opioids used during surgery and certain medicines for cough, cold or diarrhoea).
Opioid medicines may not work effectively in patients taking Mysimba, because one of the active substances in Mysimba, naltrexone, blocks the effects of opioids. There is also a risk of rare but serious and potentially life-threatening reactions, such as seizures and serotonin syndrome (a potentially life-threatening condition that results from having too much serotonin in the body), in people taking Mysimba together with medicines for treating depression and opioids.
To minimise these risks, patients and healthcare professionals are reminded that Mysimba must not be used in people who are dependent on opioids, people receiving treatment with opioid agonists such as methadone or buprenorphine and people going through acute opioid withdrawal.
People using Mysimba will be given a patient card to be carried with them at all times. The card will remind them to inform their doctor, in case of surgery, that they are using Mysimba. This is because Mysimba should be stopped for a minimum of three days before starting treatment with opioids, which are often used to prevent pain and discomfort during surgery and medical procedures.
The product information for Mysimba is being updated to reflect these changes.
Advice for healthcare professionals:
• Insufficient intra- and post-operative opioid analgesia has been described in case reports and the literature in patients treated with Mysimba.
• Rare but serious and potentially life-threatening reactions such as seizures and serotonin syndrome have been observed after co-administration of Mysimba with a serotonergic agent (such as selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine re-uptake inhibitors (SNRIs)) and opioids.
• Mysimba must not be used in patients dependent on opioids, patients treated with opioid agonists used in opioid dependence (e.g. methadone, buprenorphine) or patients in acute opioid withdrawal. If opioid use is suspected, a test may be performed to ensure clearance of opioid medication before starting treatment with Mysimba.
• Patients must be warned against the concomitant use of opioids during treatment with Mysimba. If opioid use is required (e.g. due to a planned surgery), Mysimba should be stopped for a minimum of three days before starting opioid treatment.
• In case of emergency surgery in patients potentially treated with Mysimba, there is a risk that the effects of opioids may be reduced.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/updated-advice-minimise-risks-interaction-between-weight-loss-medicine-mysimba-opioids
In Hong Kong, Mysimba is a registered pharmaceutical product under the name Contrave Prolonged-release Tablets 8mg/90mg (HK-66934), a prescription-only medicine and is the only registered pharmaceutical product containing naltrexone and bupropion. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to naltrexone and combination product of naltrexone with bupropion. The DH has received 5 cases of adverse drug reactions with bupropion but these cases were not related to concomitant use of bupropion with opioids.
Related news previously issued by EMA was posted on the Drug Office website on 27 Jul 2024. Letters to inform local healthcare professionals were issued by the DH on 29 Jul 2024. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Saturday, Nov 16, 2024
Issued at HKT 12:00
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