Other safety alerts
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| European Union: PRAC confirms that modified-release paracetamol containing medicines should be suspended from market |
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The PRAC has confirmed its recommendation that modified- or prolonged-release paracetamol containing medicines should be suspended from marketing.
This follows a re-examination of the previous recommendation that was made in September 2017 by the Committee. The re-examination was requested by two companies marketing modified-release paracetamol or modified-release paracetamol with tramadol.
The Committee confirmed in its re-examination that it could not identify practical means to minimise the risk to patients, or a feasible and standardised way to adapt the management of paracetamol overdose across the EU to allow for treatment of cases that involve modified-release preparations.
The Committee therefore still recommended that marketing of modified-release paracetamol medicines should be suspended. Immediate-release paracetamol products, which are not affected by this review, will continue to be available as before.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../human_referral_prac_000062.jsp&mid=WC0b01ac05805c516f
In Hong Kong, there are 7 registered pharmaceutical products containing paracetamol in modified-/prolonged-release dose form and they belong to non-prescription medicines. The 7 products include Clariflu Sustained Release Tab (HK-47205) which is registered by Bayer Healthcare Ltd; Panadol Joint Extended Release Caplet 665mg (HK-59436), Panadol Long Lasting Tab 665mg (HK-51314), Panadol Extend Tab 665mg (HK-51316) and Panadol Extend Tab 665mg (Ireland) (HK-52683) which are registered by GlaxoSmithKline Consumer Healthcare (Hong Kong) Limited; Xykaa Extend Prolonged Release Tablet 650mg (HK-61400) which is registered by Evercare Pharmaceutical Co. Ltd; and Ensid-ER Extended Release Tablet 650mg (HK-62272) which is registered by LSB (HK) Ltd.
So far, the Department of Health (DH) has received 10 adverse drug reaction cases related to overdose/ liver injury after taking paracetamol. In February 2011, the Registration Committee of the Pharmacy and Poisons Board had discussed the risk of liver toxicity related to paracetamol, and decided that the sales packs of paracetamol products should include warnings on the potential risks of liver toxicity and damage, and advices against using more than the recommended dose and against using more than one product containing paracetamol. Related news of PRAC recommendation was posted on Drug Office Website on 2 September 2017. A letter to inform healthcare professionals to draw their attention on the EMA recommendation was issued on 4 September 2017.
In view of the EMA’s confirmation on the previous recommendation, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Saturday, December 2, 2017
Issued at HKT 13:00
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