ADR that result in revision of patient information
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| European Union: PRAC considers risk of severe allergic reactions with ambroxol- and bromhexine-containing medicines to be small |
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The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of medicines containing ambroxol or bromhexine. This follows concerns over the risk of allergic reactions with these medicines, which are widely used as expectorants (to help clear mucus from the airways).
The PRAC considers that the risk of allergic reactions is small, but has recommended that the product information for these medicines should be updated with further information on severe allergic reactions, and that severe skin reactions (SCARs) should be introduced as a side effect. SCARs include conditions such as erythema multiforme and Stevens-Johnson syndrome.
The review of ambroxol and bromhexine was carried out at the request of the Belgian medicines agency (AFMPS) following reports of allergic reactions and SCARs with ambroxol. Several cases of SCARs, possibly linked to ambroxol, were also identified from the medical literature. The review also covered medicines containing bromhexine, since bromhexine is mainly converted into ambroxol in the body. In addition, there were some reports linking the use of bromhexine with allergic reactions.
The PRAC assessed the available data and all reports of severe allergic reactions and SCARs with ambroxol and bromhexine. The PRAC confirmed the already known risk of allergic reactions, which remains small. The Committee also identified a small risk of SCARs associated with these medicines. Based on these conclusions, the PRAC recommended adding the risk of SCARs to the product information, together with advice to discontinue treatment immediately if symptoms of SCARs occur.
The PRAC recommendation will now be forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which will adopt a final position.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002248.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are 467 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 day to draw their attention to the matter. The EMA later started a review of ambroxol and bromhexine, and the news was posted on the Drug Office website on 12 April 2014. 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 announcement on completion of the review by the EMA, a letter to healthcare professionals will be issued to draw their attention to the update, and 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/ Tuesday, January 13, 2015
Issued at HKT 14:00
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