其 他 安 全 警 示
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| European Union: EMA starts review of sodium oxybate in alcohol dependence (English only) |
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European Medicines Agency (EMA)’s announces that EMA’s human medicines committee (CHMP) has started a review of medicines containing sodium oxybate used in people with alcohol dependency to treat alcohol withdrawal syndrome and to support long term abstinence.
The review was triggered by the assessment of a marketing authorisation application in France for a generic medicine containing sodium oxybate. During the assessment, the French medicines agency had concerns about the effectiveness of sodium oxybate in alcohol dependence, based on data from three studies. There were also concerns about the risk of abuse or misuse due to the medicine’s psychoactive properties (effects on the brain), and whether the current measures to minimise these risks are adequate.
Based on these data, EMA will now assess the overall benefit-risk balance of sodium oxybate to treat alcohol withdrawal syndrome and support long-term alcohol abstinence and will review measures to mitigate the risk of abuse or misuse. The Agency will then decide if any regulatory action should be taken.
More about the medicine
Medicines containing sodium oxybate (175 mg/ml) are used in adults with alcohol dependence on their own or as an add-on medicine to treat alcohol withdrawal syndrome and to support long-term abstinence under medical supervision, along with psychotherapy (counselling) and social rehabilitation.
Sodium oxybate attaches to receptors (targets) on nerve cells of the brain and spinal cord for a substance called gamma-aminobutyric acid (GABA), leading to a calming of the activity of these cells. Since it targets these receptors in the same way as alcohol, sodium oxybate is used to treat the symptoms of alcohol withdrawal in alcohol-dependent patients, including agitation, tremor (shaking) and problems sleeping, and to support abstinence.
Sodium oxybate 175 mg/ml has been authorised nationally in Austria and Italy for use in alcohol dependent patients, under the name Alcover. In Austria, it is available as a syrup for the treatment of alcohol withdrawal syndrome and to support long-term abstinence under medical supervision along with psychotherapy (counselling) and social rehabilitation. In Italy, it is available as an oral solution for use as an adjuvant (add-on) medicine to control acute alcohol withdrawal syndrome.
Sodium oxybate oral solution (500 mg/ml) is also used to treat narcolepsy. The review does not include these medicines.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/ema-starts-review-sodium-oxybate-alcohol-dependence
In Hong Kong, there is no registered pharmaceutical product containing sodium oxybate.
Ends/Saturday, Jun 21, 2025
Issued at HKT 12:00
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