WHO Expert Committee on Drug Dependence – WHO Technical Report Series, No. 915 – Thirty-third Report
(2003; 31 pages) [French] [Spanish] View the PDF document
Table of Contents
View the document1. Introduction
View the document2. Scheduling criteria
Close this folder3. Critical review of psychoactive substances
View the document3.1 Critical review
View the document3.2 Amfepramone (INN)
View the document3.3 Amineptine (INN)
View the document3.4 Buprenorphine (INN) Substance identification
View the document3.5 Delta-9-tetrahydrocannabinol
View the document3.6 Tramadol (INN)
Open this folder and view contents4. Pre-review of psychoactive substances
View the document5. Terminology used in reporting abuse-related adverse drug reactions
View the document6. Other matters
View the documentAcknowledgements
View the documentReferences
View the documentAnnex Terminology used in reporting abuse-related adverse drug reactions
 

3.2 Amfepramone (INN)

Substance identification

Amfepramone is chemically 2-(diethylamino) propiophenone (CAS No. 90-84-6 for base, 134-80-5 for hydrochloride). It is also known as diethylpropion. Amfepramone is marketed under many trade names.

Previous review

Amfepramone was included in Schedule IV of the 1971 Convention at the time of its adoption. It was reviewed by a WHO Review Group in 1980 (5), which concluded that there was no evidence to recommend a change in the level of its international control. Amfepramone was pre-reviewed at the previous meeting of the Committee (4) when a critical review was recommended based on information from the International Narcotics Control Board (INCB) that abuse and illicit trafficking of amfepramone had been reported from nearly all regions of the world, and had become particularly widespread in Asia and the Russian Federation.

Similarity to known substances and effects on the central nervous system

Amfepramone is an anorectic amphetamine analogue used for treating obesity. It has a spectrum of pharmacological effects similar to that of scheduled amphetamines, including the release of dopamine.

Dependence potential

Dependence on amfepramone can occur but there are few data available on its incidence. In some patients, tolerance to the anorectic effects of the drug may occur within 6 to 12 weeks. Amfepramone has been shown to produce euphoria and other mood changes characteristic of drugs of abuse.

Actual abuse and/or evidence of likelihood of abuse

Information from INCB indicates that illicit traffic in amfepramone has been reported from many countries and regions. In several countries in South America, overuse of anorectic stimulants has led to additional educational and regulatory actions being undertaken by the authorities. However, the small number of adverse drug reaction reports related to abuse received by the international drug monitoring programme does not suggest a high liability of amfepramone to abuse. The response of governments to the WHO questionnaire also indicated that diversion and abuse of the drug were limited.

Therapeutic usefulness

Amfepramone has been used as an oral anorectic in the treatment of obesity, although stimulants are not generally recommended for this indication. The drug is indicated only as an adjunct to other forms of therapy (such as caloric restriction, exercise and behaviour modification techniques). Some medicinal regulatory authorities in the European Union have already withdrawn amfepramone from the market because of concerns about its safety. The global consumption of amfepramone has been decreasing since 1997, in line with the decline in the total consumption of stimulants in Schedule IV of the 1971 Convention.

Recommendation

The Committee judged that according to the scheduling criteria set out in the Guidelines, a psychotropic substance in Schedule IV of the 1971 Convention, such as amfepramone, should have a liability to abuse that poses a “significant” risk to public health. The Committee did not recommend a change in the scheduling status of amfepramone since the information available to it was insufficient to justify placing this drug in Schedule II or III which require that a substance constitutes a “substantial” risk to public health. Law enforcement data on the extent of illicit activities involving stimulants in other schedules of the 1971 Convention may enable the risk of abuse of amfepramone to be compared with abuse of other stimulants in the future. In the meantime, in view of the existing concern about its safety in medical use, the Committee recommended that informational and educational activities to curb its overuse be intensified.

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