24 November 2000
The Registration Committee of the Hong Kong Pharmacy and Poisons Board discussed 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:
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. Details are -
Bolarmine Capsules (Registration No. HK-45560)
Diet-B Capsules (HK-45561)
Slimonin Capsules (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.
Cough-and-cold remedies should be upgraded from Part 1 to Part 1 First Schedule 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 labeling will have to be revised, where necessary, to limit the dosage to no more than 100mg daily. Also, Manufacturers will be required to strengthen the warning section in the product literature, including not using the product as an appetite suppressant.
You are advised to supply or use PPA-containing pharmaceutical products with caution. In particular, patients with high blood pressure, hyperthyroidism, heart disease or who are receiving monoamine oxidase inhibitors should not use these products. These products may also aggravate conditions such as diabetes, glaucoma or prostatic enlargement.
Before the upgrading is effected through legislative amendment, pharmacists in dispensaries are requested to personally advise the purchasers on the above possible adverse effects and precautions and recommend alternatives available where appropriate. You are also encouraged to report to Pharmaceutical Service Headquarter any adverse effects possibly associated with PPA usage.