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Canada Gazette Home > Publications > Vol. 150 (2016) > June 1, 2016 > Regulations Amending the Food and Drug Regulations (Parts G and J — Lefetamine, AH 7921, MT 45 and W 18)
Vol. 150, No. 11 — June 1, 2016
Registration
SOR/2016 106 May 20, 2016
CONTROLLED DRUGS AND SUBSTANCES ACT Regulations Amending the Food and Drug Regulations (Parts G and J — Lefetamine, AH-7921, MT-45 and W-18)
P.C. 2016 372 May 20, 2016
His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 55(1) (see footnote a) of the Controlled Drugs and Substances Act (see footnote b) , makes the annexed Regulations Amending the Food and Drug Regulations (Parts G and J — Lefetamine, AH-7921, MT-45 and W-18) .
Regulations Amending the Food and Drug Regulations (Parts G and J — Lefetamine, AH-7921, MT-45 and W-18)
Amendments
1 Item 12 of Part I of the schedule to Part G of the Food and Drug Regulations (see footnote 1) is replaced by the following:
12 Lefetamine (( ) N,N dimethyl α phenylbenzeneethanamine), its salts, derivatives and isomers and salts of derivatives and isomers
2 Part I of the schedule to Part J of the Regulations is amended by adding the following after item 24:
25 AH 7921 (1 (3,4 dichlorobenzamidomethyl)cyclohexyldimethylamine), its salts, isomers and salts of isomers 26 MT 45 (1 cyclohexyl 4 (1,2 diphenylethyl)piperazine), its salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues, including
(1) Diphenidine (DEP) (1 (1,2 diphenylethyl)piperidine) (2) Methoxphenidine (2 MeO Diphenidine, MXP) (1 [1 (2 methoxyphenyl) 2 phenylethyl]piperidine) (3) Ephenidine (NEDPA, EPE) (N ethyl 1,2 diphenylethylamine) (4) Isophenidine (NPDPA) (N isopropyl 1,2 diphenylethylamine) but not including (5) Lefetamine (( ) N,N dimethyl α phenylbenzeneethanamine), its salts, derivatives and isomers and salts of derivatives and isomers
27 W 18 (4 chloro N [1 [2 (4 nitrophenyl)ethyl] 2 piperidinylidene]benzenesulfonamide), its salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues
Coming into Force
3 These Regulations come into force on the 180th day after the day on which they are published in the Canada Gazette , Part II.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Regulations and the Order .)
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Issues
The non medical use of pharmaceuticals such as opioid analgesics has emerged as one of North America’s leading public health and safety concerns. Canadians are the second highest per capita users of prescription opioid drugs in the world. Opioids are a highly addictive class of drugs and available data shows an overall high degree of harms, intoxication and deaths attributed to opioids.
Although most opioids are listed in Schedule I to the Controlled Drugs and Substances Act (CDSA), the synthetic opioids AH 7921, MT 45 and W 18 are not currently controlled under the CDSA. They have no known use apart from scientific research and are considered new psychoactive substances (NPS), also known by terms such as “designer drugs” or “research chemicals.”
AH-7921
Reported adverse effects from AH 7921 include hypertension, tachycardia and seizures. (see footnote 2) Fifteen deaths have been associated with AH 7921 in Europe, one in the United States (U.S.) (see footnote 3) and one in Canada. (see footnote 4)
In March 2015, the United Nations Commission on Narcotic Drugs (CND) voted in favour of controlling AH 7921, under Schedule I to the Single Convention on Narcotic Drugs, 1961 (the 1961 Convention). As a signatory, Canada is obliged to impose controls on this substance.
MT-45
The clinical symptoms reported from non fatal intoxications of MT 45 include respiratory depression, unconsciousness, paraesthesia, balance and vision disturbances. Persistent hearing loss has also been associated with its use. (see footnote 5) Twenty eight deaths have been associated with MT 45 in Europe and two deaths in the U.S. (see footnote 6)
In March 2016, the CND voted in favour of controlling MT 45 under Schedule I to the 1961 Convention. As with AH 7921, Canada is obliged to impose controls on this substance.
W-18
Available evidence suggests that W 18 is an extremely potent analgesic, with one pain test on mice showing W 18 to be potentially up to 10 000 times more active an analgesic than morphine. (see footnote 7) This suggests a potential severe risk for overdose.
Risks associated with AH 7921, MT 45 and W 18 can be further elevated because of a lack of data about toxicity, bioavailability, tolerance, half life and onset of effects, which can lead users to rely on self reported experiences and other information from user web forums, which may be inaccurate.
These substances have similar abuse potential to other opioids already controlled under the CDSA, but they are not currently subject to the same controls.
Isomers and derivatives of lefetamine
The chemical structure of MT 45 is related to that of lefetamine, a stimulant with analgesic effects. Lefetamine combines amphetamine