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HEALTH

Dunne: Health Ministry to recall Kronic brand

Thursday 30 June 2011, 2:47PM

By Peter Dunne

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Associate Health Minister Peter Dunne today announced that the Ministry of Health is recalling one of the most popular brands of the synthetic cannabis product Kronic because contains the prescription medicine phenazepam.

Mr Dunne said finding phenazepam – an anti-anxiety and anti-convulsion drug – in the Kronic product, Pineapple Express, again confirms the dangers of suppliers putting unregulated drugs on the market where their safety is unproven.

“This clearly shows the worth of the Government’s moves to change the onus of proof so producers and suppliers of these products need to prove they are safe before they can sell them,” he said.

Currently authorities have to prove such products are unsafe before they can be taken off the market.

”This particular product, because it contains a prescription medicine, is now illegal to buy, sell, use or possess without a doctor’s prescription,” he said.

Mr Dunne said this restriction applies to sellers – the retailer, wholesaler and distributors – and any member of the public who buys the product.

The Health Ministry is contacting Lightyears Ahead, the company that supplies the product, to officially inform it that is required to recall Pineapple Express from retailers immediately.

The Ministry will conduct further investigations before making any decision on a possible prosecution.

A similar product is also being investigated and further action may be taken shortly.

The recall comes as the Government is moving in the next few weeks to place restrictions on the sale and marketing of products such as those containing synthetic cannabinoids in proposed amendments to the Misuse of Drugs Act.

Smokefree legislation means that it is already illegal to sell these products to those under 18.

Today’s move by the Health Ministry comes after testing of a range of synthetic cannabis products confirmed the presence of a prescription medicine only in Kronic Pineapple Express.

Testing of a total of around 40 of these products by Environmental Science and Research (ESR) is currently being undertaken.

Phenazepam is a prescription medicine that can be particularly harmful to those with a mental health condition; to those on other medications; to pregnant women; and to children.

Its effects are more pronounced when combined with alcohol.

Mr Dunne said anyone concerned about the health consequences of taking this product and wanting more information should call Healthline 0800 611 116.

Questions and Answers:

Why is this product illegal?
The Ministry of Health believes this product is in breach of the Medicines Act 1981 because it contains a medicine being distributed without the consent of the Minister of Health. Medsafe has today contacted the supplier and required them to quarantine stock in hand and recall stock from retailers.

What does this product contain?
It contains an unauthorised substance called phenazepam. Phenazepam is a member of a class of products called benzodiazepines that are scheduled as prescription medicines.

What effects does phenazepam have?
When used at doses between 0.5 to 2 mg taken orally, phenazepam is reported to have anti-anxiety (and anticonvulsant) activity. Reported side effects include, loss of coordination, dizziness, drowsiness and anterograde amnesia (inability to remember recent events). At higher doses, double vision, delirium and psychosis have been reported.
Phenazepam is highly potent and is easy to overdose on and often results in loss of inhibitions and unusual behaviour.

When taken with alcohol the effects of alcohol and/or phenazepam will be pronounced.

The use of phenazepam can lead to dependence.

There is no information available regarding the safety or effects of phenazepam when smoked. When taken this way phenazepam may denature into other chemicals that may be toxic in their own right.

Are products containing synthetic cannabinoids still legal?
Yes, though the Government is proposing changes to the Misuse of Drugs Act to make sales illegal to people under the age of 18 and provide for a number of other restrictions. The Government is also considering the Law Commission report into the control and regulation of drugs which advocated a new regulatory framework for new or unregulated substances like the synthetic cannabinoids in Kronic Pineapple Express.

If a consumer is taking one of these recalled products what should they do?

Stop taking them and safely destroy the product or return it to the retailer for a refund.

If a retailer is selling this product, what should they do?
Take if off the shelves and return it to their supplier.

Have the other products on sale in New Zealand been tested?
ESR is currently testing a range of these related products. Initial screening has identified another product which is currently being investigated further. If the presence of a prescription medicine is found at a level causing concern similar regulatory action will be taken by Medsafe.

Who imports and manufactures Kronic Pineapple Express?
The Ministry understands that the supplier in NZ is Lightyears Ahead Limited, an Auckland-based company.

Where can I find more information about the health effects of Kronic Pineapple Express; its active ingredients; and side effects?
Anyone concerned about the health effects should in the first instance ring Healthline on 0800 611 116.

What is the penalty for breaches to the Medicines Act?
Section 20 of the Medicines Act 1981 require medicines to be approved before distribution in New Zealand.

Breaches of Section 20 where an unapproved medicine is distributed can result in a fine of $20,000 and six months prison for an individual and $100,000 for a body corporate.

Timeline
20 May 2011: A screening test by ESR found phenazepam present in Kronic Pineapple Express and scientific validation process begun by ESR
9 June: additional samples provided to ESR for testing
16 June: reference standard - required for court evidential process - received by ESR from overseas.
21 June: all three samples confirmed to contain phenazepam.
27 June: ESR requested to confirm quantity of phenazepam in the three samples
29 June: phenazepam confirmed at levels higher than 10 parts per million.