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Director-General's Statement - Super Fat Burning

Director-General's Statement
Under Section 98 Of The Medicines Act 1981
3 June 2005

Director-General of Health Dr Karen Poutasi is today warning people about a herbal product after investigation and testing has revealed it contains an undeclared prescription medicine.

The product is called Super Fat Burning, which has been sold by traders on the TradeMe web site and may have been available through other Internet selling sites.

The Ministry of Health's medicines safety authority (Medsafe) is warning consumers not to take Super Fat Burning because it contains the prescription medicine sibutramine. Sibutramine is a prescription medicine which may be used to treat very overweight (obese) patients who have not been able to lose weight using a low calorie diet and exercise.

Sibutramine can cause increased blood pressure and heart rate and cannot safely be taken by a range of persons, including those with glaucoma, mental illness and severe liver or kidney problems. Nor should it be used in combination with other medicines such as some antidepressants and migraine treatments.

Super Fat Burning is not approved as a medicine in New Zealand. Because it contains sibutramine, a prescription medicine, its consumption poses a safety risk to consumers if taken without medical supervision. Medsafe has instructed distributors to stop supplying the product immediately.

Consumers are being warned to immediately stop taking Super Fat Burning. Dr Poutasi says people using Super Fat Burning should seek medical advice from their doctor:

- if they are taking other medicines

- if they felt unwell when taking Super Fat Burning

- if they become unwell after stopping Super Fat Burning

Background information

The Super Fat Burning product was investigated following complaints received by Medsafe about the poor quality of the product. Subsequent testing showed that it contained the prescription medicine sibutramine.

As this product contains a prescription medicine, it is considered to be a medicine distributed without the consent of the Minister, in contravention of the Medicines Act 1981. Before the Minister gives consent to the distribution of a medicine, its quality, safety and efficacy must be assessed against and meet international guidelines. This approval process has not occurred with this product.

Consequently, Medsafe has required the sellers of Super Fat Burning to immediately stop supplying it. Stocks of the product have been seized. Further investigations are underway into the importation and supply of the product in New Zealand.

Karen O Poutasi (Dr)

Director-General of Health

QUESTIONS AND ANSWERS

Which product is involved?

Super Fat Burning: it contains the prescription medicine sibutramine.

Sibutramine is a prescription medicine used to treat very overweight (obese) patients who have not been able to lose weight using a low calorie diet and exercise. Super Fat Burning was being sold as a natural substance for ‘burning fat’ and weight reduction.

Why is this product being removed from the market?

It is a breach of the Medicines Act 1981 for so-called herbal products to contain undeclared prescription medicines. There is also potential for harm to occur when prescription medicines are unknowingly used by consumers, particularly in the absence of medical supervision. Sibutramine can cause increased blood pressure and heart rate. Patients using sibutramine must see their doctor for a check-up every two weeks during the first three months of treatment in order to monitor the effects of use. Additionally, sibutramine must not be given to certain persons (for example, those with glaucoma, mental illness, severe liver or kidney problems) nor should it be used in combination with medicines such as some antidepressants and migraine treatments.

What is the usual dose range for sibutramine?

Legitimately, sibutramine is present in the prescription medicine Reductil. The usual daily dosage for Reductil is 10mg up to a maximum of 15mg daily. The Super Fat Burning product seen by Medsafe contains approximately 12mg per capsule. The label states that two capsules should be taken daily which would amount to 24 mg daily.

If a consumer is taking Super Fat Burning what should they do?

Consumers are being warned to immediately stop taking this product. Consumers should seek medical advice from their doctor:

- if they are taking other medicines

- if they felt unwell when taking Super Fat Burning

- if they become unwell after stopping Super Fat Burning

How many people take this product in NZ?

There is no reliable information about how many people have taken this product. However, Medsafe has sent a letter by e-mail to 111 persons known to have purchased it.

How was this illegal product being sold?

Super Fat Burning was being sold by two traders on the TradeMe website and may be available through other Internet retailing sites.

Can this product still be sold?

No. Medsafe has required the distributors of this product to immediately cease supplying it. Stocks have been seized from known sellers.

What responsibilities do distributors and importers have?

Distributors, importers and sellers are responsible for ensuring products they import or sell that are not approved medicines do not contain any prescription medicines. Also, it is illegal to sell or supply prescription medicines without the purchaser having a prescription from a registered medical practitioner. Under the food and medicine legislation, sponsors/distributors/importers are required to list all active ingredients on the packaging, and to include the strength of each active ingredient.

Is there information available for the consumers about the active ingredient?

Sibutramine is the active ingredient in Reductil. Consumers seeking general information about sibutramine can access the Consumer Medication Information about Reductil on the Medsafe web site.

General warning for consumers about any products making therapeutic claims available via the Internet Medsafe warns consumers that products making therapeutic claims being sold through websites may not be legal in New Zealand. All products for which a therapeutic benefit is being claimed must first be ‘approved’ by the Minister of Health before they can be marketed.

Consumers should also be alert to complementary healthcare products that appear to be of poor quality, cause side effects, or appear to be unusually effective or are available from unusual sources. Any concerns should be reported to Medsafe. See the Medsafe website for contact details.

Important advice to Internet traders

Medicines are products sold or supplied principally for a therapeutic purpose. Selling, distributing or advertising the availability of a medicine which has not been given a consent or provisional consent by the Minister is in breach of section 20 of the Medicines Act 1981. On conviction, the maximum penalty for an individual who sells a medicine without first having it registered through the regulatory process administered by Medsafe is $20,000 or up to 6 months in prison. Unless a product is an approved medicine, sellers must ensure that claims of a therapeutic purpose are not made for products they advertise or sell AND they must ensure that their products do not contain scheduled medicines.

What does Super Fat Burning look like?

There are photographs on the Medsafe website:www.Medsafe.govt.nz

ENDS

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