Tenuate Retard: EU withdrawal and safety

EU withdrawal of Tenuate Retard

Tenuate Retard is a withdrawn medicine in the EU. The European Commission issued a legally binding decision on 13 January 2023 to revoke the marketing authorisations of amfepramone obesity medicines, including Tenuate Retard. It applies across the EU, including Spain.

This page provides historical and safety information. It does not offer a prescription, supply route or current dosing instructions for Tenuate Retard. A displayed price or availability label must not be treated as evidence that this withdrawn product can be supplied.

What was Tenuate Retard?

Tenuate Retard was a modified-release amfepramone (diethylpropion) product. The EMA referral names a 75 mg modified-release tablet; it must not be confused with the capsules of other amfepramone products.

Amfepramone is a sympathomimetic. Its action in the brain reduces hunger, but stimulant effects can also affect the cardiovascular system and mental health. “Modified release” does not remove these risks.

Historical use and duration

The former authorisations concerned obesity with BMI at least 30 kg/m² when other weight-reduction methods had not worked alone. They specified 4–6 weeks of use and no longer than 3 months. These are historical restrictions, not instructions to start or continue treatment.

The withdrawal review found use beyond the permitted duration, in people with heart disease or psychiatric disorders, and during pregnancy. It concluded that available restrictions had not adequately limited the risks. Tenuate Retard must not be presented as a current second- or third-line alternative when another weight medicine is unsuitable.

Risks identified in the withdrawal review

Pulmonary arterial hypertension: high blood pressure in the arteries of the lungs.
Cardiovascular harm: heart disease and related complications.
Dependence: problematic use and difficulty stopping.
Psychiatric problems: risk was especially concerning in people with a psychiatric history.
Pregnancy harm: risk to the unborn baby.

The review also found limited benefit in obesity treatment. Historical studies or a comparison with other stimulants do not reverse the binding withdrawal. This is not a complete historical adverse-effect list, and these risks are not assigned a common frequency category.

If you are taking or have obtained amfepramone

Contact a doctor or pharmacist promptly to review the medicine, any symptoms and a plan for further care. Do not use an old dosing table or an online offer as a reason to start, restart or extend treatment. Tell the clinician about other medicines, especially MAO inhibitors, and any cardiovascular disease, high blood pressure, hyperthyroidism, psychiatric illness, substance dependence, pregnancy or breastfeeding.

New breathlessness, chest pain, fainting or severe palpitations need urgent medical assessment. Severe mood changes or thoughts of self-harm also require urgent help. Do not increase the dose to compensate for reduced appetite suppression.

Other approaches to weight management

A doctor can assess dietary, physical-activity and behavioural support and whether an authorised medicine is suitable. The fact that another treatment exists does not establish individual eligibility, stock or a safer choice.

Xenical contains orlistat and has its own indications, digestive effects and interactions. Ozempic contains semaglutide but is authorised for type 2 diabetes; it must not be conflated with Wegovy’s weight-management indication. None should be described as having no cardiovascular risk or being universally well tolerated.

Prescrivia’s role

Prescrivia is a technology intermediary connecting patients with independent doctors. It does not prescribe medicines, employ doctors or sell medicines. An independent assessment may consider other weight-management approaches; it does not make Tenuate Retard available or override the withdrawal. No prescription or outcome is guaranteed.

In Spain, distance sale of prescription medicines is prohibited under Article 3.5 of Royal Legislative Decree 1/2015. An online assessment does not remove this restriction. Dispensing and access depend on the exact product and applicable national rules.

Source

EMA: amfepramone referral and final withdrawal decision, overview, patient/professional information, historical product description and key dates/outcome.

This article does not replace individual advice from a doctor or pharmacist.

Frequently asked questions

What was Tenuate Retard used for?

Tenuate Retard contained amfepramone, also called diethylpropion, an appetite suppressant formerly used for short-term obesity treatment. Its EU marketing authorisation was withdrawn following the binding Commission decision of 13 January 2023.

How long can I take Tenuate Retard?

This page does not provide a current treatment course. Historical amfepramone authorisations limited use to 4–6 weeks and no longer than 3 months. Those restrictions did not adequately control the risks, and EU authorisations were withdrawn.

Is Tenuate Retard a stimulant?

Amfepramone is a sympathomimetic that acts in the brain to reduce hunger. The withdrawal review identified cardiovascular, psychiatric and dependence risks; it should not be described as a safer or mild stimulant option.

Why were the authorisations withdrawn?

EMA concluded that benefits did not outweigh risks and that further restrictions would not adequately address misuse. Risks included pulmonary arterial hypertension, heart disease, dependence, psychiatric problems and harm during pregnancy.

Can I get Tenuate Retard online in Europe?

This article must not be read as an offer to obtain Tenuate Retard. The EU marketing authorisations were withdrawn. Speak to a doctor about other approaches to weight management; an online assessment does not override the withdrawal.

Tenuate Retard (Amfepramon)