Warning from the Medicines and Medical Devices Safety Authority on five Chinese medicine products
2007-05-01
Director-General of Health, Stephen McKernan, is warning people about the potential health dangers associated with 5 Chinese medicine products which have been found to contain undeclared prescription medicines for weight loss and erectile dysfunction.
This statement about the 5 products is being issued by the Director-General under Section 98 of the Medicines Act 1981, following investigations by the Ministry of Health's medicines safety arm, Medsafe.
Testing of the products, apparently imported from Asia and being sold as Chinese medicines, found that each contained undeclared prescription medicines. These products have now been seized and removed from shelves, Stephen McKernan says.
One product, labelled Dai Dai Hua Jiao Nang, was found to contain the prescription medicine sibutramine, which is used for the treatment of some overweight (obese) patients. Sibutramine can cause increased blood pressure and heart rates and cannot be safely taken by a range of people, including those with glaucoma, mental illness and severe liver or kidney problems. It should not be used in combination with other medicines, such as some antidepressants and migraine treatments.
Testing of the four other Chinese medicine products showed they all contained sildenafil, a prescription medicine used to treat erectile dysfunction. These products were labelled "Darling Capsules"; "Dali Capsules"; "Spanish Fly Capsules"; and an unnamed product comprised orange capsules in plastic and silver foil blister packs.
Sildenafil is known to interfere with some heart medication and could be fatal to some individuals.
"Consumers should immediately stop taking these products and seek medical advice from their doctor if they are taking other medicines, have felt unwell when taking the products, or if they have become unwell after they stopped taking the products," Mr McKernan says.
Investigations into these products began following a complaint that a retail outlet had sold a product suspected of containing an undeclared prescription medicine.
The products appear to have been sold on request 'under-the-counter' and without any labelling or packaging indicating their ingredients or instructions for use. The investigations are continuing.
"Medsafe is actively investigating the sale and distribution of these types of products. Recently, the Ministry of Health has taken regulatory action against several individuals and companies found to be in breach of the law."
Under the medicines legislation, sponsors, distributors and importers are required to list all active ingredients on product packaging, and to include the strength of each active ingredient. Only approved prescription medicines can be sold to the public and then only under a prescription given by an authorised prescriber. It is also illegal for an individual to possess personal supplies of a prescription medicine without first having obtained a medical practitioner's prescription for them.
"We are concerned about the continuing numbers of Chinese-type medicines being found to contain undeclared prescription medicines," Mr McKernan says.
To see photographs of the products please refer to the Medsafe website:
Source: Medicines and Medical Devices Safety Authority