ADR that result in revision of patient information
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| The European Union: Ambroxol and bromhexine expectorants: safety information to be updated |
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The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) of the European Medicines Agency (EMA) has recommended update of the product information for ambroxol- and bromhexine-containing medicines with information about the small risk of severe allergic reactions and severe cutaneous adverse reactions (SCARs). The medicines are widely available in the EU for use as expectorants (to help clear mucus from the airways).
The recommendations were originally made by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which confirmed the previously known risk of allergic reactions and also identified a small risk of SCARs, a group of skin conditions which include erythema multiforme and Stevens-Johnson syndrome. The PRAC evaluated available data on ambroxol and bromhexine, including reports of severe allergic reactions or SCARs.
As a result, SCARs are now to be listed as side effects in the product information for these medicines, and patients are to stop treatment immediately if symptoms of SCARs occur. Reports of severe allergic reactions and SCARs in patients taking the medicines are rare, and the frequencies of these side effects are unknown.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002276.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are 466 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 CFDA, and was posted on the Drug Office website on 4 September 2012. Letter to healthcare professionals was issued on the same date. The EMA later started a review of ambroxol and bromhexine, and the news was posted on the Drug Office website on 12 April 2014 and 13 January 2015. With the update safety information announced, letter to healthcare professionals was issued on 13 January 2015 to draw their attention to the matter. So far, the Department of Health (DH) has not received any adverse drug reaction report in relation to the drugs. In view of the latest recommendations by the EMA, the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board. The DH will remain vigilant on the safety updates of the drugs.
Ends/Saturday, February 28, 2015
Issued at HKT 12:00
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