| News | |||
|
Recall of Kronic Pineapple Express
|
Privileged Statement Under Section 98 of the Medicines ActDirector-General of Health Kevin Woods today warned retailers to remove from their shelves a brand of herbal smoking product called Kronic Pineapple Express because it contains a prescription medicine. Mr Woods said the public should not consume this product and to seek medical advice if they are feeling unwell. Kronic Pineapple Express contains a benzodiazepine called phenazepam that is not available in NZ and only appears to be used in one country for the short term treatment of anxiety and as an anticonvulsant. Phenazepam can only be legally supplied when prescribed by a doctor or other prescriber. The Ministry of Health is meeting with the company importing and manufacturing this product today and is requesting it be recalled from retailers immediately. Retailers are also requested to remove this product from sale immediately |
 Kevin Woods Director-General of Health |
The presence of the prescription medicine was first suspected from a screening test last month. Subsequent work including a validated test and determination of the quantity of phenazepam has now been completed. The process took time as the science behind the testing was new to New Zealand and needed to be carefully undertaken so that the evidence was of a good standard.
The Ministry of Health is delivering a formal notice to the company to immediately cease supply and distribution of Kronic Pineapple Express.
The Ministry believes this product is in breach of the Medicines Act 1981 because it contains a medicine which is being distributed without consent.
Phenazepam is a member of a class of medicines called benzodiazepines. Phenazepam is structurally similar to lorazepam, a benzodiazepine available in NZ for the treatment of a number of conditions.
Anyone concerned about the health consequences of taking this product and wanting more information should call Healthline 0800 611 116.
ENDS
Date: 30 June 2011
For more information contact Peter Abernethy, Media Relations Manager, 021 366 111.
BACKGROUND 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 in three samples provided to ESR and in a fourth separate ESR sample.