NEW DRUG UNDER FORMAL SCRUTINY
Council asks EMCDDA to assess risks of BZP
(23.3.2007, LISBON) Europe has responded to rising concern over the use of the stimulant drug BZP by formally requesting an investigation into the health and social risks of the substance. The decision was announced by the Council of the EU today in line with a special legal procedure designed to respond to potentially threatening new psychoactive drugs in the EU (1).
The risk-assessment exercise, which will result in a report by mid-June, will be undertaken by the Scientific Committee of the EU drugs agency (EMCDDA), with participation of additional experts from the European Commission, Europol and the European Medicines Agency (EMEA). The exercise is part of a three-step procedure: information exchange, risk assessment and decision-making (e.g. legal controls). Today’s decision is based largely on the findings of a joint EMCDDA–Europol report on 1-benzylpiperazine (BZP) submitted on 23 February to the Council of the EU, European Commission and the EMEA in the initial information-exchange step of the process (2). This report featured information on the health effects of the drug,
frequency and patterns of use, evidence of intoxications and available information on international trafficking and the involvement of organised crime. BZP is a psychoactive drug belonging to the group of aryl-substituted piperazines which includes substances
such as mCPP and TFMPP. Health risks associated with BZP may include: hypertension, tachycardia (rapid beating of the heart), seizures, anxiety and insomnia — with certain symptoms sometimes lasting for up to 24 hours. Commenting today EMCDDA Director Wolfgang Götz said: ‘BZP was first notified to the EMCDDA and Europol via their early-warning system on new drugs back in 1999 and we have been exchanging information
on the drug with the partners in our network ever since. But towards the end of 2006 the number of BZP notifications to the EMCDDA and Europol increased, prompting us to compile our joint report in December and January’. ‘New forms of drug use are usually adopted by a few individuals, among small groups or in particular regions and social settings,’ says Götz. ‘Keeping our ear to the ground and picking up on new substances and trends is a central part of our work at the EMCDDA to ensure that problems are detected before they become major
health threats. Today we see that our detection mechanisms are working well and we are satisfied that we can now go a step further in our analysis of BZP’. As well as evaluating the health and social risks of the drug, the forthcoming report will look at the potential
implications for placing the drug under control in the EU, the final stage in the process. On the basis of the report — and at the initiative of the European Commission or a Member State — the Council may decide (by late July) for the drug to be subjected to control measures throughout the EU. The Member States would then be required to introduce such controls in line with national laws no later than one year after the Council’s decision.
New drug under scrutiny 23.3.2007
Risk assessment of BZP
2
BZP is reported by users to provoke similar effects to those of amphetamine (3). A recent study also showed that when combined with TFMPP, it may mimic some of the effects of ecstasy (4). BZP is widely available legally so there appears to be no need for illicit production.
Over the last two years, BZP-containing products have been aggressively marketed by various retailers and websites as ‘natural’ or ‘herbal’ highs and as a legal alternative to ecstasy (‘Legal E’, ‘Legal X’) (5), wrongly leading potential users to believe the drug is safe. BZP is generally taken orally in tablet form. In 2006, 13 EU Member States and non-member Norway reported to Europol and/or the EMCDDA seizures of BZP in powder, capsule or tablet form, ranging from single small seizures (Belgium and Greece) to up to 64,900 tablets (UK). The size of the latter seizure suggests the involvement of organised crime in the trafficking and wholesale distribution of BZP. Five EU Member States (Belgium, Denmark, Greece, Malta and Sweden) control BZP under drug control or equivalent legislation and two (Spain and the Netherlands) regulate it under their medicine-related legislation. The Italian Ministry of Health has recently started a procedure to bring BZP under control as a narcotic drug, while the Estonian state medicines agency is also considering introducing controls. In Ireland sales are prohibited to the under-18s. Outside Europe, the US has been controlling BZP under Schedule 1 of the Controlled Substances Act since 2004. The drug is also a controlled substance in all states of Australia as well as in Japan where it is listed as a narcotic in the Narcotics and Psychotropics Control Law. In New Zealand, where BZP has been used recreationally since 2000, sales have been prohibited to the under-18s since 2005.
On 1 January 2007, BZP was included in the prohibited list of the World anti-doping code (http://www.wadaama. org/en) as a stimulant substance prohibited in competition. BZP is currently not under assessment by the UN drug control system.
Notes:
(1) Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, risk assessment and control of new psychoactive substances [Official Journal L 127, 20.5.2005]. See two-page leaflet explaining the procedure at
http://www.emcdda.europa.eu/?nnodeID=17869.
The Council decided at its meeting on 22 March 2007 to request a risk
assessment of BZP. Today, in accordance with Article 6 of the above Council decision, it formally requested the EMCDDA to carry out this risk assessment.
(2) The joint report is available on the EMCDDA website at: http://www.emcdda.europa.eu/?nnodeID=1346. (A joint report on the substance mCPP is also available, although a risk-assessment procedure was not recommended in this case). BZP was first synthesised in 1944 by Wellcome Research Laboratories (UK) as a potential anthelmintic (to treat intestinal
parasitic worms) for livestock but it was not used as it was found to be relatively ineffective and caused adverse effects such as seizures in mammals. BZP has no known medical use (human or veterinary) in the European Union.
(3) Campbell H., Cline W., Evans M., Lloyd J., Peck AW., ‘Comparison of the effects of dexamphetamine and 1- benzylpiperazine in former addicts’, European Journal of Clinical Pharmacology 1973; Volume 6: 170–176.
(4) Baumann M.H., Clark R.D., Budzynski A.G., Partilla J.S., Blough B.E. and Rothman R.B., ‘N-substituted piperazines abused by humans mimic the molecular mechanism of 3,4-Methylenedioxymethamphetamine (MDMA or “Ecstasy”)’
Neuropsychopharmacology, 2005; 30: 550–60.
(5) BZP is also known by the lesser used codename A2. It is sold under various brand names including: Pep pills (Pep original, Pep X, Pep twisted, Pep love); Funk pills (Flying Angel, Twisted), JAX; Red Eye Frog (Californian Sunrise, Strawberry Fields) Triple X (XXX), Efx.