Press Release
Deregistration of rectal suppository containing domperidone 10mg
9 July 2014
The Department of Health (DH) today (July 9) drew the public's attention to the decision of the Pharmacy and Poisons (Registration of Pharmaceutical Products and Substances: Certification of Clinical Trial/Medicinal Test) Committee (the Registration Committee) of the Pharmacy and Poisons Board to deregister a rectal suppository containing domperidone 10mg with effect from October 1, 2014, because the benefits of the product no longer outweigh its risks.
The Registration Committee's decision was made at its meeting on July 7, after taking into consideration the findings from overseas studies and the usage information of the product in Hong Kong.
Domperidone, taken orally or as a rectal suppository, is generally used as an antiemetic agent for the short-term treatment of nausea and vomiting.
The Registration Committee noted that domperidone in certain doses is clearly associated with a small increased risk of potentially life-threatening effects on the heart while data supporting the effectiveness of domperidone 10mg rectal suppositories are limited. Hence, the Registration Committee decided to deregister a rectal suppository containing domperidone 10mg with effect from October 1, 2014.
In Hong Kong, there is currently one registered rectal suppository containing domperidone 10mg, namely Domper Suppository 10mg (registration number: HK-42477), which is a non-prescription medicine. The DH has issued letters to inform health-care professionals of the Registration Committee's decision to deregister the product, and to advise them to arrange suitable alternative treatment for their patients.
As for oral products containing domperidone, the Registration Committee has recommended that local drug manufacturers and wholesalers should strengthen the products' information on dosage and indication according to the recommendations of overseas regulatory authorities.
"When the Registration Committee's decision takes effect on October 1, 2014, all drug wholesalers, retailers and health-care professionals must stop selling or supplying the rectal suppository containing domperidone 10mg. The wholesalers concerned are also required to recall the product from the market by September 30, 2014. The DH will take enforcement action against any illegal possession or sale of such a product afterwards," a DH spokesman said.
Under the Pharmacy and Poisons Ordinance (Cap 138), illegal sale or possession for the purpose of sale of unregistered pharmaceutical products are both criminal offences. The maximum penalty for each offence is a fine of $100,000 and two years' imprisonment.
"Doctors and pharmacies should stop prescribing or dispensing the rectal suppository containing domperidone 10mg. Patients using the product are advised to consult their health-care professionals to review their treatment plans as soon as possible," the spokesman advised.
