Press Release
DH reminds public on deregistration of rectal suppository containing domperidone 10mg with effect from October 1
24 September 2014
The Department of Health (DH) today (September 24) reminded the public that rectal suppository containing domperidone 10mg would be deregistered and could not be sold in the market with effect from next Wednesday (October 1).
After taking into consideration that domperidone in certain doses was clearly associated with a small increased risk of potentially life-threatening effects on the heart while data supporting the effectiveness of domperidone 10mg rectal suppository were limited, the Pharmacy and Poisons (Registration of Pharmaceutical Products and Substances: Certification of Clinical Trial/Medicinal Test) Committee of the Pharmacy and Poisons Board of Hong Kong decided at its meeting on July 7 to deregister rectal suppository containing domperidone 10mg. To allow sufficient time for doctors to review treatment plans and switch to suitable alternative treatments for their patients, the Committee decided that the deregistration would not take effect until October 1. Apress releasewas issued on July 9.
Domperidone, taken orally or used as a rectal suppository, is generally used as an antiemetic agent for the short-term treatment of nausea and vomiting.
Locally, there is currently one registered pharmaceutical product of rectal suppository containing domperidone 10mg, namely Domper Suppository 10mg (registration number: HK-42477) which is a non-prescription medicine. The DH has notified health-care professionals of the Committee's decision and related recommendations, and requested the wholesaler concerned to recall its pharmaceutical product from the market.
"Patients who are still using the pharmaceutical product concerned should contact their doctors immediately for switching to suitable alternative treatments. We have issued letters of reminder to health-care professionals and the wholesaler concerned regarding the commencement date of deregistration," a spokesman for the DH said.
With effect from October 1, all drug wholesalers, retailers and health-care professionals must stop selling or supplying rectal suppository containing domperidone 10mg. The wholesaler must recall all its pharmaceutical products from the market by September 30, after which the DH will take enforcement action against any illegal possession or sale of unregistered pharmaceutical products. Under the Pharmacy and Poisons Ordinance (Cap 138), the sale and possession of unregistered pharmaceutical products are both criminal offences. The maximum penalty for each offence is a fine of $100,000 and two years' imprisonment.
"In addition, the Committee decided to strengthen the sales control of the remaining oral products containing domperidone so that they could be sold only by prescription at pharmacies under the supervision of pharmacists and the DH's follow-up is under way. The DH also noted the recent similar decision by the Medicines and Healthcare Products Regulatory Agency of the United Kingdom that their oral domperidone products would be available only as prescription medicines. The DH will remain vigilant on safety updates and actions by other overseas health authorities," the spokesman added.
