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Following is a question by the Hon Lau Kong-wah and a written reply by the Secretary for Health and Welfare, Dr E K Yeoh, in the Legislative Council today (November 29):

Question:

It was reported that the Food and Drug Administration ("FDA") of the United States had decided to legislate against the use of phenylpropanolamine in drugs. In this connection, will the Government inform this Council:

(a) of the drugs containing phenylpropanolamine which are being sold in Hong Kong; the side-effects of such drugs on people, and whether relevant indications are marked on the package of such drugs;

(b) whether any reports have been received over the past three years concerning the side-effects of these drugs on people; and

(c) whether the Administration will make reference to the relevant study report of the FDA and consider legislating against the sale of such drugs; if not, of the reasons for that?

Answer :

Madam President,

(a) Pharmaceutical products containing phenylpropanolamine (PPA) have been in use for more than 20 years. There are currently about 200 registered pharmaceutical products containing phenylpropanolamine. Given in significant doses, PPA has been known to cause a rise in blood pressure. In a recent study conducted by United States scientists, an increased risk of haemorrhagic stroke (internal bleeding of the brain) among women using PPA was detected. PPA is currently controlled as a Part I poison (i.e. Part I of the Poisons List of the Poisons List Regulations) under the Pharmacy and Poisons Ordinance Cap. 138, which means that all pharmaceutical products containing it must be sold by authorized sellers of poisons (i.e. dispensaries) under the supervision of a registered pharmacist. Products containing PPA are required to provide information on its side effects in the package insert. Moreover, products containing PPA on sale in Hong Kong must carry the statement, in both English and Chinese, on the label or in the package insert that "If you are under the care of your doctor or receiving continual prescribed medication or are pregnant then consult your doctor.".

(b) The Department of Health (DH) has not received any report of adverse reactions arising from the use of pharmaceutical products containing PPA in the past three years.

(c) The Registration Committee of the Pharmacy and Poisons Board (PPB) considered the latest reports on the side effects of PPA, including the findings of the USA study, at its meeting on 24 November 2000. The Committee concluded that the association of PPA with haemorrhagic stroke is significant only when PPA is used in appetite suppressant products, the use of which is often on a long-term basis. Accordingly, the Committee decided to deregister all such products, namely -

Bolarmine Capsule

Diet-B Capsule

Slimonin Capsule

DH has informed the manufacturers of the three products of the Committee's decision, which will take effect on 23 December 2000 (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 three products from dispensaries and doctors' clinics, and the public is advised to cease using them and to consult their doctor or pharmacists for alternative treatment.

The Registration Committee has also recommended to the PPB that the control of cough-and-cold remedies containing PPA should be tightened by including them in the First Schedule of the Pharmacy and Poisons Regulations. This means that every time a pharmacist sells such products, he must make a record of the sale, sign it and also require the customer to sign. Subject to PPB's decision, the relevant amendment regulation providing these additional control measures will be submitted to the Legislative Council for approval.

The Registration Committee has also decided that labelling of these remedies should be revised to limit the dosage to no more than 100 mg of PPA daily. Manufacturers are also required to strengthen the warning section in the product literature, including a warning not to use the product as an appetite suppressant. Manufacturers are given a grace period of two months to effect the necessary changes.

DH has individually informed all registered doctors, pharmacists, dentists and dispensaries of the above. They are also advised to supply or use pharmaceutical products containing PPA with caution.

End/Wednesday, November 29, 2000

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