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Director-General of Health warning about the personal importation of adulterated and counterfeit prescription medicines

The Director-General of Health, Stephen McKernan, is warning the New Zealand public about four products that have been illegally promoted in Singapore for the treatment of erectile dysfunction but have been found to contain dangerous levels of a prescription medicine used to treat diabetes.

The products are believed to have caused one death, up to 30 serious adverse reactions and 59 other possible adverse reactions in Singapore.

Medsafe was alerted to the products by the Singapore Health Sciences Authority (HSA). The products are: Power 1 Walnut, Santi Bovine Penis Erecting Capsule, Zhong Hua Niu Bian and a product branded as Cialis but found to be a counterfeit of the genuine product. All four products contain glibenclamide, a prescription medicine used to treat diabetes as well as prescription medicines used to treat erectile dysfunction.

The Medsafe Investigations and Enforcement Team and New Zealand Customs staff have identified a product destined for a New Zealand address that appears to be the counterfeit version of Cialis reported by the HSA. The product was being imported by an individual and is believed to have been purchased through the internet. Samples are being tested by ESR.

Stephen McKernan warns that there is a possibility that these medicines may become available to the New Zealand public as a result of people importing them for personal use. Not all such imports may be able to be detected by border surveillance.

Consumers can identify the products that are believed to pose a risk of harm from the photographs available at:

Photographs of the counterfeit Cialis detected at the New Zealand border.

Stephen McKernan warns that these four products should not be taken nor distributed to others. If anyone has taken one of these products, medical advice should be sought as soon as possible.

Glibenclamide acts by lowering blood sugar levels and its use by consumers who do not have diabetes can produce serious side effects including coma and possible death.

"It's important to note that there are no safety concerns with genuine Cialis products that are currently available on a prescription and obtained from a New Zealand pharmacy," said Stephen McKernan, Director-General of Health.

The product sponsor, Eli Lilly, is concerned about this counterfeiting development and is working with New Zealand and international authorities to investigate the matter.

Stephen McKernan said "New Zealanders need to be confident the prescription medicines they take are genuine and true to label. The only way to do this is to obtain them from a New Zealand pharmacy, with a prescription written by a New Zealand-registered practitioner or authorised prescriber."

Background:

Questions and answers

What to do if one of these products has been taken?

Stop taking the product immediately. Contact a doctor immediately if you feel unwell. Even if you have not felt unwell, consult your doctor at the earliest opportunity. Information about this issue can be obtained by the public and health professionals from the Medsafe website.

Medsafe has reported many instances where undeclared prescription medicines have been detected in unapproved imported medicines, why is this case different?

This case is different because the products in question contain dangerous levels of an undeclared prescription medicine that is used to treat diabetes and that could have serious and possibly fatal consequences for anyone taking them. Glibenclamide is not used to treat erectile dysfunction and should not be present in such a product.

Although Medsafe is not aware of any of these products reaching consumers in New Zealand, there is a possibility that this may happen.

What are the issues with counterfeit medicines available over the internet?

Medsafe has noted for some time that counterfeit medicines have appeared at the border in consignments destined for individuals purchasing over the internet. In February this year Medsafe received the results of testing of some 27 products believed to be counterfeit that were seized at the border during the second half of 2007. Testing confirmed that all of the products contained an erectile dysfunction prescription medicine (either sildenafil or tadalafil). In many cases the products were contaminated with other medicine active ingredients indicating poor manufacturing quality or further evidence of fraud. The poor labelling and presentation of the products also indicated their quality was below the standards required in New Zealand. Countries of origin included: India, China and Thailand.

The World Health Organisation has expressed its concern about the growing international trade in counterfeit medicines and the health risks these pose and has set up a task force to deal with the problem globally. Although the extent of counterfeiting is impossible to measure, the WHO notes that more than 30% of the medicines available in some countries are counterfeit. This is significant when purchasing over the internet because it may not be possible to determine where a website is based or from which country the medicines are being supplied.

Why should prescription medicines not be purchased via the internet?

Medsafe strongly advises consumers not to purchase prescription medicines over the internet especially where a valid New Zealand prescription is not required by the website. Medicines are classified as prescription medicines because a health professional (usually a medical doctor or other authorised health professional) needs to be involved in the process to ensure the patient receives an adequate medical diagnosis, that the risks and benefits of a medicine are fully considered and that ongoing care and monitoring is available if appropriate.

Is it legal to import prescription medicines for personal use?

In general, members of the public may only possess or take prescription medicines if they have been prescribed for them by a New Zealand-registered medical practitioner or a person authorised to prescribe under New Zealand law. Certain health professionals and others licensed under the Medicines Act may also possess, supply and/or administer a prescription medicine.

Prescription medicines imported by individuals are stopped at the border and will only be released to the purchaser when a suitable authorisation has been given by a medical doctor or other authorised person.

Why is the undeclared presence of glibenclamide a problem?

Glibenclamide is a potent hypoglycaemic agent. This means it reduces the levels of sugar (glucose) in blood. Glibenclamide is used to help control diabetes.

Glibenclamide can be very harmful if taken by people who do not have diabetes because it can decrease the levels of glucose in the brain, which may lead to brain damage. Even small amounts of glibenclamide can be harmful. The usual dose of glibenclamide is up to 15mg daily with a maximum of 20mg. The products in question contain up to 100mg of glibenclamide which far exceeds a safe dose.

There have been reports of death caused by people taking too much of this medicine. If glibenclamide is taken with alcohol or certain other medicines, there is an increased risk of the sugar levels in the blood becoming too low. People with liver or kidney problems are also more likely to experience these harmful effects if they take glibenclamide.

More information about glibenclamide is available by typing glibenclamide in the search engine at: www.medsafe.govt.nz

Why should erectile dysfunction medicines only be taken after consultation with a medical doctor?

Erectile dysfunction medicines are not suitable for everyone and consultation with a qualified medical professional is important to ensure this type of medicine is appropriate. Medicines containing sildenafil and tadalafil (the active ingredients in Viagra and Cialis respectively) should not be used in patients with severe hepatic impairment (liver disease), bleeding disorders (eg haemophilia), active peptic ulceration (stomach ulcers), hypotension (low blood pressure), hypertension (high blood pressure), recent history of stroke or myocardial infarction (heart attack), unstable angina (heart pain), heart failure, known hereditary degenerative retinal disorders (eye disease).

Sildenafil or tadalafil should never be used by patients on nitrate medication (used for prevention of angina) as the interaction between the two medicines can be potentially fatal.

More information about tadalafil or sildenafil is available by typing either name in the search engine at: www.medsafe.govt.nz

Is the Cialis that is available in New Zealand through a doctor’s prescription and from a pharmacy affected by this warning?

No. This warning only applies to counterfeit Cialis which is being imported by individuals for their personal use. It does not affect legitimate Cialis supplies within the New Zealand supply chain.