Other safety alerts
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| Australia: Advisory Committee on Medicines Scheduling to consider upscheduling to 'Pharmacist Only': modified release paracetamol |
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The TGA has asked the Advisory Committee on Medicines Scheduling (ACMS) to consider whether one form of paracetamol - modified release (MR) paracetamol - should become a 'Pharmacist Only' medicine.
MR paracetamol is used in Australia to treat chronic pain, especially in the elderly, and is currently an S2 'Pharmacy Only' medicine. It is a separate product from the more widely used immediate release (IR) paracetamol available from pharmacies and supermarkets. MR paracetamol contains a higher dosage of paracetamol than IR paracetamol, and it is released over a longer period, meaning the product can be taken three times a day, rather than four. IR paracetamol would be unaffected by any upscheduling decision.
The TGA has conducted a review of the safety of MR paracetamol in Australia, and sought the advice of the Advisory Committee on Medicines (ACM), following a decision by the European Medicines Agency (EMA) to suspend marketing of MR paracetamol products in the European Union. The EMA's decision was based on increased risks to people who overdosed on MR paracetamol compared to IR paracetamol.
Any decision to upschedule MR paracetamol to S3 'Pharmacist Only Medicine' would maintain access to these products in pharmacies, but give pharmacists the opportunity to check that patients are using the medicine correctly and counsel them on the importance of not exceeding the recommended dose.
The scheduling submission will be considered by ACMS in March 2019. Its recommendations will then be considered by the delegate of the Secretary of the Department of Health.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/modified-release-paracetamol
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 EMA recommendation to suspend modified-release paracetamol containing medicines from market was posted on the Drug Office website on 2 September 2017 and 2 December 2017. A letter to inform healthcare professionals to draw their attention on the EMA recommendation was issued on 4 September 2017. The matter has been discussed by the Registration Committee of the Pharmacy and Poisons Board on 8 February 2018 and it was agreed that DH would continue to remain vigilant on new safety announcements for paracetamol issued by other overseas drug regulatory authorities.
Ends/ Saturday, Sep 8, 2018
Issued at HKT 13:00
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