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The Registration Committee of the Pharmacy and Poisons Board has decided that pharmaceutical products containing propoxyphene should be deregistered for public health protection, a spokesman for the Department of Health said today (December 29). This is to take effect from January 10, 2011, to allow for necessary recall follow-up.
The decision was taken at the Committee's meeting today after taking into consideration all the information available, including the effects of propoxyphene on human cardiac electrophysiology at therapeutic dose range, the availability of alternative analgesic drugs in Hong Kong and regulatory actions taken by other lead regulatory agencies.
Internationally, propoxyphene has either been suspended or withdrawn from use in countries in the European Union, Singapore, the United Kingdom and the United States.
After due risk assessment, the Committee concluded that the increased risks of serious abnormal heart rhythms caused by propoxyphene at therapeutic doses outweighed its benefits for pain relief. Therefore, a decision to deregister pharmaceutical products containing propoxyphene was made.
Currently, there are 21 pharmaceutical products registered to contain propoxyphene (in the form of dextropropoxyphene) and being supplied by 13 companies in Hong Kong.
The spokesman said wholesalers concerned should immediately stop trading or distributing propoxyphene-containing products and instead recall them from shelves before or by January 10, 2011. Doctors and pharmacists should also stop prescribing or dispensing propoxyphene-containing products and return their stocks to the respective wholesalers.
Hotlines for public enquiries and the contact list are in the enclosure.
Under the Pharmacy and Poisons Regulations, any person who sells, offers for sale, distributes or possesses for the purposes of sale, distribution or other use any deregistered pharmaceutical products is liable to prosecution with a maximum penalty of two years imprisonment and a fine of $100,000 on conviction.
The spokesman added that patients who are taking propoxyphene-containing products should consult their doctors or pharmacists to discuss alternative measures for pain management. The Department of Health will closely monitor the recall of propoxyphene-containing products.
Ends/Wednesday, December 29, 2010
Issued at HKT 19:02
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