Recommendation (from TRS)

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 treat- ing 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 avail- able 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 character- istic 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 coun- tries 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 monitor- ing 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 modifi- cation 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.

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 consti- tutes 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 educa- tional activities to curb its overuse be intensified.

ECDD Recommendation

No change in scheduling