ADR that result in revision of patient information
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| European Union : European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) recommends suspension of tetrazepam-containing medicines |
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European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the suspension of tetrazepam-containing medicines following a review initiated at the request of France in January 2013.
The PRAC assessed all available data on the risk of skin reactions with tetrazepam based on post-marketing data in Europe and the published literature. Stakeholders (healthcare professionals, patients and the general public) were also able to submit relevant information to support the assessment. The PRAC concluded that tetrazepam is associated with a low but increased risk of serious skin reactions compared with other benzodiazepines. The Committee also noted that in the light of the risks identified, the available data on its effectiveness were not sufficiently robust to support its use in the authorised indications: treatment of painful muscle contractures (such as in low back pain and neck pain) and spasticity (excessive stiffness of muscles). The PRAC considered that measures had not been identified to sufficiently reduce the risk of serious skin reactions with tetrazepam-containing medicines given the uncertainties about the benefits. Therefore, the Committee concluded that the benefit-risk balance for these medicines is negative, and recommended that the marketing authorisations be suspended throughout the EU. It recommended that, for the suspension to be lifted, the companies that market these medicines should provide data identifying a specific group of patients for whom the benefits of tetrazepam-containing medicines outweigh the risks.
As tetrazepam-containing medicines are all authorised nationally, the PRAC recommendation will now be considered by Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) , which will adopt a final scientific opinion. The final opinion is expected to be adopted at the CMDh meeting in April 2013.
Please refer to the following website at EMA for details :
http://www.ema.europa.eu/../news_detail_001759.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, the above product is not a registered pharmaceutical product. Related news issued by EMA was posted on the website of Drug Office on 12 January 2013.
Ends/ Saturday, April 13, 2013
Issued at HKT 12:00
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