Editorially reviewed by Dr Fatimah Khan, registered with the Pakistan Medical and Dental Council (PMDC no. 104595-P). Editorial medical reviewer; does not prescribe or review patient assessments.
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Review scope: This article edition.
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Why does diethylpropion need a regulatory-history explanation?
Diethylpropion is also known as amfepramone. Historic names include Tenuate Retard and Regenon. Older articles may describe its use as an appetite suppressant, but that history must not be presented as evidence of a currently authorised treatment pathway.
The relevant European review concerns amfepramone itself, not merely another appetite suppressant with a similar mechanism.
What the regulator records show
The EMA amfepramone referral records a revocation outcome and a European Commission final decision dated 13 January 2023.
The EMA's January 2023 communication explains the withdrawal of marketing authorisations for the reviewed amfepramone medicines within the EU. The review found that measures intended to restrict use had not sufficiently controlled risks.
This is stronger and more specific evidence than saying simply “not EMA-authorised”. National authorisation and an EU safety referral are distinct processes; absence of a central authorisation alone does not determine a medicine's legal status.
Which concerns informed the decision?
The review identified use for longer than recommended and use in people with relevant heart or psychiatric conditions, as well as during pregnancy. Concerns included:
- Pulmonary arterial hypertension, involving high blood pressure in the lung arteries.
- Heart and psychiatric problems.
- Dependency.
- Potential harm during pregnancy.
The regulator concluded that further risk-minimisation measures would not sufficiently address the problem. These findings should not be replaced by a general comparison with sibutramine.
Why this guide gives no historical dose
A historical dose table can suggest a route to self-treatment even when the authorisations discussed have been withdrawn. It does not answer whether a product is appropriate, lawful or obtainable today.
If you encounter an old pack or an online seller, take the details to a pharmacist or clinician. Do not infer current legality in another jurisdiction from this article. Country-specific checks and any exceptional legal pathways require qualified review.
Discussing weight-management care
Different authorised medicines have their own indications, contraindications and evidence. No alternative should be described as free of cardiovascular risk, dependence risk or adverse effects solely because its mechanism differs.
Our medicine-access safety guide explains service checks. Prescrivia is a technology intermediary; independent clinicians determine whether assessment or another care pathway is appropriate. This historical article offers no amfepramone access route and guarantees no prescription or outcome.
General information only, not medical advice. Follow the leaflet for your actual product and discuss decisions with a qualified clinician. See the current clinical, legal and language review statuses for this edition.
Sources
- EMA amfepramone referral: nationally authorised products, revocation outcome and European Commission final decision on 13 January 2023.
- EMA January 2023 communication: risk-minimisation failures, pulmonary arterial hypertension, dependence and other concerns underlying withdrawal.
Sources checked online on 6 October 2026. Country-specific guidance does not establish availability or prescribing rules throughout Europe.