Other safety alerts
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| European Union: Start of review of ambroxol and bromhexine |
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The European Medicines Agency has started a review of medicines containing ambroxol and bromhexine, which are widely used as expectorants (medicines that help clear the airways), as well as to relieve sore throat. Some formulations are used to treat breathing disorders in premature and newborn babies.
The review of ambroxol and bromhexine was requested by the Belgian medicines agency (AFMPS). This follows concerns over an increased number of reports of allergic reactions, including anaphylactic (severe allergic) reactions with ambroxol. Medicines containing ambroxol have also been linked to severe skin adverse reactions. In addition, the AFMPS was concerned about the use of ambroxol as expectorant in children below 6 years of age and considered that the benefits of these medicines did not outweigh the risks in this population.
The European Medicines Agency will now review the available data on the benefits and risks of medicines containing ambroxol and bromhexine, and issue an opinion on the marketing authorisations of these medicines across the European Union (EU).
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002071.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are 481 and 48 registered pharmaceutical products containing bromhexine and ambroxol, respectively. Related news on the risk of severe hypersensitivity reactions of ambroxol injection has been released by the China Food and Drug Administration (CFDA) and was posted on the Drug Office website on 4 September 2012. Letter to inform healthcare professionals on the issue was issued on 4 September 2012. The Department of Health will remain vigilant on any safety updates of the drugs and actions taken by overseas regulatory authorities of any action deemed necessary.
Ends/ Saturday, April 12, 2014
Issued at HKT 12:00
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