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The Department of Health (DH) today (May 2) urged members of the public to pay attention to the decision by the Pharmacy and Poisons (Registration of Pharmaceutical Products and Substances: Certification of Clinical Trial/Medicinal Test) Committee of the Pharmacy and Poisons Board to deregister pharmaceutical products containing the combination of a corticosteroid and a non-steroidal anti-inflammatory drug (NSAID) with effect from January 1, 2014, because the benefits of the products no longer outweigh their risks.
The Committee's decision was made at its meeting on April 30 after taking into consideration that the risk of gastro-intestinal bleeding and ulceration associated with an NSAID will be increased when it is used in combination with a corticosteroid and that the DH has received local reports of adverse drug reactions related to such a combination of ingredients. The Committee noted that patients should not stop using the products abruptly as sudden withdrawal of a corticosteroid may lead to serious health consequences. Therefore, it decided that the deregistration will take effect on January 1, 2014, to provide a transition period for doctors to switch to alternative treatments for their patients. The DH will issue letters to health-care professionals to inform them of the Committee's decision and related matters.
Both corticosteroids and NSAIDs have anti-inflammatory effects and have been used for the symptomatic relief of rheumatoid pain. Both of them may lead to gastro-intestinal bleeding and the risk is increased when a corticosteroid and an NSAID are used concomitantly.
Currently, there are 66 registered pharmaceutical products containing the combination of a corticosteroid and an NSAID as ingredients manufactured by six local manufacturers and they are all prescription-only medicines, which can only be sold by pharmacies under the supervision of registered pharmacists upon doctors' prescription. The products are listed in the Attachment.
"When the Committee's decision takes effect on January 1, 2014, all drug manufacturers, wholesalers and retailers must stop selling or distributing pharmaceutical products containing the combination of a corticosteroid and an NSAID. The manufacturers are also required to recall the products concerned from shelves by December 31, 2013. The DH will then prosecute traders for illegal possession or sale of such products afterwards," a DH spokesman said.
Under the Pharmacy and Poisons Ordinance (Cap 138), sale and possession of unregistered pharmaceutical products are both criminal offences. The maximum penalty for each offence is a fine of $100,000 and two years' imprisonment.
"Patients taking medicines containing the combination of a corticosteroid and an NSAID are advised to consult their health-care professionals to review their treatment plans as soon as possible. They should not stop using these medicines abruptly as sudden withdrawal of a corticosteroid may lead to serious health consequences," the spokesman advised.
Ends/Thursday, May 2, 2013
Issued at HKT 19:21
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