Health warning - Section 98 of the Medines Act
8 December 2008
Health warning issued under Section 98 of the Medicines Act 1981
Director-General of Health Stephen McKernan is warning the public about the potential health dangers associated with six products sold from an Auckland supermarket selling Chinese goods.
This statement about the six 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.
The products are:
• Santi Scalper Penis Erection Capsules (Santi Nui Ban). This product contains the undeclared ingredients sildenafil (a prescription medicine used to treat erectile dysfunction).
• Masaone capsules. This product is labeled as containing the ingredient piroxicam, a potent anti-inflammatory medicine.
• Ankahuangmin Jiaonang (Paracetamol, Caffeine, Artificial Cow Bezoar and Chlorpheniramine Maleate Capsules). This product is presented as blister packs containing red/clear capsules with blue Chinese print on the foil backing and is labeled as containing chlorpheniramine maleate, an antihistamine used to treat allergies, and paracetamol used to treat pain and fever.
• Lufen Huang Min Pian (Compound Diclofenac Tablet). This product is presented in a silver tin containing silver foil blister packs each containing blue tablets. There is Chinese writing in black on the silver backing foil and this is labeled as containing diclofenac, an anti-inflammatory medicine, and chlorpheniramine maleate, an antihistamine used to treat allergies.
• Madame Pearl’s Cough Syrup. This product is labeled as containing noscapine hydrochloride, a cough suppressant; phenylephrine hydrochloride, a decongestant; guaiphenesin hydrochloride, an expectorant and chlorpheniramine maleate, an antihistamine.
• Madame Pearl’s Cough Syrup (for Children) is labeled as containing noscapine hydrochloride, a cough suppressant; guaiphenesin hydrochloride, an expectorant and chlorpheniramine maleate, an antihistamine.
The safety, quality and efficacy of these products are unknown as they have not been assessed for supply in New Zealand through the medicines approval process.
The Santi Scalper Penis Erection and Masaone products contain prescription medicines and should only be used on the advice of an authorised prescriber after the benefits and risks of their use have been assessed. The other products contain pharmacist or pharmacy-only ingredients and should only be sold from a pharmacy where a qualified healthcare professional is available for advice.
Medicines approved for sale without a prescription are required to be labeled in English with instructions on their intended purpose and dosage. Consumers are encouraged to report instances where labeling appears to not meet these requirements. Medicines for more serious conditions are only available from a pharmacy.
"Consumers should immediately stop taking these products and seek medical advice from their doctor if they are taking other medicines or if they have felt unwell when taking any of these products,"said Mr McKernan.
Questions and Answers
What is wrong with these products?
The Santi Scalper Penis Erection Capsules contain the undeclared therapeutic substances, sildenafil and homosildenafil. Viagra is the only brand of sildenafil approved for sale in New Zealand and is used for managing erectile dysfunction. Sildenafil is known to interfere with some heart medications and could be fatal to some individuals. Sildenafil should only be used on the advice of an authorized New Zealand prescriber after the benefits and risks of use have been assessed.
More information about medicines that interact with sildenafil and other precautions relating to its use can be found by accessing the Consumer Medication Information on the Medsafe website by typing Viagra into the search engine at: www.medsafe.govt.nz/search.
The Masaone capsules contain piroxicam, a prescription medicine used as an anti-inflammatory for treating pain, swelling and inflammation due to musculo-skeletal conditions such as arthritis. Piroxicam can cause serious reactions, such as stomach upset, ulceration, and bleeding. Piroxicam can also interact with other medicines. As a result, piroxicam should only be used on the advice of an authorized New Zealand prescriber after the benefits and risks of use have been assessed.
More information on the effects of piroxicam can be found by accessing the Consumer Medication Information on the Medsafe website by typing piroxicam into the search engine at: www.medsafe.govt.nz/search.
The Lufen Huang Min Pian tablets contain diclofenac sodium and chlorpheniramine maleate in a presentation which would make the product a pharmacist only medicine. Diclofenac, like piroxicam, can also cause serious reactions and may interact with other medicines. Diclofenac should only be used on the advice of a heathcare professional.
The Ankahuangmin Jiaonang capsules and the Madame Pearl’s products contain common cough and cold ingredients. These products should only be sold from a pharmacy where healthcare professional advice is available as they may not be suitable for some people who have certain health conditions or who are taking other medicines. In addition, the use of cough suppressants is not recommended in children under two years of age.
If a consumer is taking one of these products what should they do?
Consumers are being warned to immediately stop taking these products and seek medical advice from their doctor if they are taking other medicines or have felt unwell when taking the products. There is no reliable information about how many people have taken these products.
Adverse reactions to these products should be reported to the Centre for Adverse Reactions Monitoring: www.carm.otago.ac.nzConsumers can also report any concerns to Medsafe: www.medsafe.govt.nz
Have these products been removed from sale?
Stock held by one retailer has been seized by Medsafe investigations staff. Some of the products have been sold by a wholesaler to several retail outlets. This stock has been recalled. Medsafe is continuing to investigate the matter and may take further regulatory action if required.
Have the products on sale in New Zealand been tested?
Santi Scalper Penis Erection Capsules have been tested and found to contain sildenafil and homosildenafil (an analogue of sildenafil that is believed to have similar therapeutic actions). The other products have not been tested because the ingredients are stated in English on the labels.
Where can I find more information about Viagra and its active ingredient and side effects?
Consumers seeking general information about Viagra and its active ingredient sildenafil can access the Consumer Medication information on the Medsafe website by typing the trade name of the product into the search engine at: www.medsafe.govt.nz/search
What about other similar products for sexual enhancement?
Many products appear to be available from retailers and over the internet claiming to be for sexual enhancement, to improve sexual performance or for the treatment of erectile dysfunction. Because of the illicit international trade in these products it is not possible for anyone to be certain about the contents of any of the unapproved products on sale in New Zealand. Previous investigations by Medsafe have identified a number of supposedly natural products adulterated with medicines such as sildenafil.
The concern and risk of serious consequences (including death) is real enough for Medsafe to warn against taking any of these products.
Important advice to traders
Under the medicines legislation, sponsors, distributors and importers are required to obtain approval before they sell or distribute products intended for a therapeutic purpose. Retailers cannot sell products that have not first been approved for sale under the provisions of the Medicines Act 1981.
Section 20 of the Medicines Act 1981 requires medicines to be approved before distribution in New Zealand. A breach of this requirement carries substantial penalties.
On conviction, the maximum penalty for an individual who sells a medicine without first having it approved through the regulatory process administered by Medsafe is $20,000 or up to 6 months in prison.
On conviction, the maximum penalty for a body corporate which sells a medicine without first having it approved through the regulatory process administered by Medsafe is $100,000.
The Ministry of Health takes breaches of the medicines laws very seriously, especially where patient and consumer safety is put at risk, and regulatory action will be taken as necessary to ensure compliance.
Images of the products can be found on Medsafe's website at www.medsafe.govt.nz