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The following is issued on behalf of the Registration Committee of the Hong Kong Pharmacy and Poisons Board:


Plan to de-register appetite suppressants containing PPA

November 24, 2000

The Registration Committee of the Hong Kong Pharmacy and Poisons Board brought forward its December meeting to this morning (Nov 24) to discuss the latest reported side effects of phenylpropanolamine (PPA).

The committee studied in detail the report of the U.S. Yale University School of Medicine which finds that PPA may be associated with haemorrhagic stroke (internal bleeding of the brain), particularly when used in appetite suppressant products. The committee also considered the use of PPA products available in Hong Kong, and follow-up regulatory decisions of other health authorities.

The committee has concluded that:

(1) According to all available evidence, the association of PPA with haemorrhagic stroke is significant only when PPA is used in appetite suppressant products. Such use is often on a long-term basis. Accordingly, such products should be deregistered and should no longer be legally sold in Hong Kong. There are 3 such products:

Bolarmine Capsule (Registration No. HK-45560)

Diet-B Capsule (Registration No. HK-45561)

Slimonin Capsule (Registration No. HK-35791)

The manufacturers of the 3 products are being informed of the above decision, which will take effect on December 23 (at the lapse of the 4-week statutory period for the lodgement of an appeal against the decision, if any). Meanwhile, these manufacturers are requested to immediately recall the 3 products from dispensaries and doctors' clinics, and the public is advised to cease using them and to consult their doctor or pharmacist for alternative treatments.

(2) Cough-and-cold remedies should be upgraded from Part 1 to Part 1 Schedule 1 poison. (This means that every time a pharmacist sells the product, he must make a record of the sale, sign it and ask the customer to sign it too. Currently, the requirement is that the product should only be sold under the pharmacist's supervision). In the case of these remedies, the labelling will have to be revised, where necessary, to limit the dosage to no more than 100 mg daily. Also, Manufacturers will be required to strengthen the warning section in the product literature, including not using the product as an appetite suppressant.

Doctors, pharmacists and dispensaries are being issued a letter highlighting the above decision of the Registration Committee and reminding them to exercise caution when products containing PPA are supplied to members of the public.

The above information, together with the list of products containing PPA will be uploaded onto the Department of Health (DH)'s Website. For enquiries on PPA products, members of the public can use DH's Pharmaceutical Service Hotline (2961 8789). The Hotline will be operated until 9:00 pm today (November 24) and from 9:00 am until 6:00 pm tomorrow (November 25).

二零一五年十二月十八日