European Medicines Agency recommends suspension of marketing authorisations for meprobamate-containing medicines in the European Union

 

Gradual withdrawal period of 15 months recommended

 

London, UK (January 20, 2012) – The European Medicines Agency has recommended the suspension of all marketing authorisations for meprobamate-containing medicines for oral use in the European Union, because their risks, particularly the risk of serious side effects affecting the nervous system, are greater than their benefits. To ensure prescribers have enough time to determine the most appropriate treatments for individual patients, the Committee has recommended that the withdrawal of the medicines from the market be carried out gradually, within 15 months of the European Commission decision.

 

Doctors should stop prescribing meprobamate-containing medicines over the next 15 months and consider alternative treatments in line with national recommendations for the condition being treated. Patients currently taking the medicines should discuss their treatment with their doctor at their next routine appointment.

 

Meprobamate is a sedative medicine used to treat the symptoms of anxiety and related conditions, including anxiety states, alcohol withdrawal, migraine attacks, digestive disorders, muscle tension or cramps, and insomnia.

 

The review of meprobamate-containing medicines was started because the French authorities announced in July 2011 their intention to suspend the marketing authorisations for oral meprobamate-containing medicines because of serious side effects seen with these medicines.

 

The Agency’s Committee for Medicinal Products for Human Use (CHMP) reviewed all available data on the safety and efficacy of these medicines, including data from studies, post-marketing surveillance and the published literature, as well as from poison control centres on cases of poisoning with meprobamate.

 

The CHMP noted that there was a risk of serious and potentially fatal side effects, such as coma, in patients taking meprobamate-containing medicines under normal conditions of use. The Committee considered that these risks were increased due to the danger of unintentional overdose because of the small difference between the treating dose and the dose that can harm patients, including elderly people. The CHMP also noted that some patients can become addicted to the medicine, leading to serious and sometimes fatal side effects if they stop treatment abruptly after using it for a long time.

 

The Committee concluded that the benefits of meprobamate-containing medicines for oral use do not outweigh their risks

 

 

Notes

 

  • Meprobamate-containing medicines have been authorised in a number of EU Member States for several decades via national procedures. They are currently authorised in France, the Netherlands, Finland, Hungary, Italy, Romania, the United Kingdom, Iceland and Norway under the invented name Equanil and other trade names.
  • The review was carried out under Article 107 of Directive 2001/83/EC, as amended. This type of procedure is triggered when a Member State varies, suspends or revokes the marketing authorisation for a medicine in its territory because of a safety issue.
  • The Committee’s opinion has been forwarded to the European Commission for the adoption of a decision.
  • All other opinions and documents adopted by the CHMP at its January 2012 plenary meeting will be published on Friday, 20 January 2012 at 12.00 noon UK time on a dedicated web page.

 


 

European Medicines Agency (EMA), 20.01.2012 (tB).

MEDICAL NEWS

Inadequate sequencing of SARS-CoV-2 variants impedes global response to COVID-19
New meta-analysis finds cannabis may be linked to development of…
New guidance on how to diagnosis and manage osteoporosis in…
Starting the day off with chocolate could have unexpected benefits
Better mental health supports for nurses needed, study finds

SCHMERZ PAINCARE

Versorgung verbessern: Deutsche Gesellschaft für Schmerzmedizin fordert die Einführung des…
Pflegeexpertise im Fokus: Schmerzmanagement nach Operationen
Versorgung verbessern: Bundesweite Initiative der Deutschen Gesellschaft für Schmerzmedizin zu…
Jedes vierte Kind wünscht bessere Schmerzbehandlung
Lebensqualität von Patienten in der dauerhaften Schmerztherapie mit Opioiden verbessern

DIABETES

Bundestag berät über DMP Adipositas: DDG begrüßt dies als Teil…
Mit der Smartwatch Insulinbildung steuern
Verbände fordern bessere Ausbildung und Honorierung von Pflegekräften für Menschen…
Minimalinvasive Geräte warnen ungenügend vor Unterzuckerung
Typ-1-Diabetes und Hashimoto-Thyreoiditis treten häufig gemeinsam auf

ERNÄHRUNG

Wie eine Diät die Darmflora beeinflusst: Krankenhauskeim spielt wichtige Rolle…
DGEM plädiert für Screening und frühzeitige Aufbautherapie: Stationäre COVID-19-Patienten oft…
Führt eine vegane Ernährungsweise zu einer geringeren Knochengesundheit?
Regelmässiger Koffeinkonsum verändert Hirnstrukturen
Corona-Erkrankung: Fehl- und Mangelernährung sind unterschätze Risikofaktoren

ONKOLOGIE

Anti-Myelom-Therapie mit zusätzlich Daratumumab noch effektiver
Positive Ergebnisse beim fortgeschrittenen Prostatakarzinom: Phase-III-Studie zur Radioligandentherapie mit 177Lu-PSMA-617
Lymphom-News vom EHA2021 Virtual. Alle Berichte sind nun online verfügbar!
Deutsch-dänisches Interreg-Projekt: Grenzübergreifende Fortbildungskurse in der onkologischen Pflege
Sotorasib: Neues Medikament macht Lungenkrebs-Patienten Hoffnung

MULTIPLE SKLEROSE

NMOSD-Erkrankungen: Zulassung von Satralizumab zur Behandlung von Jugendlichen und Erwachsenen
Verzögerte Verfügbarkeit von Ofatumumab (Kesimpta®)
Neuer Biomarker bei Multipler Sklerose ermöglicht frühe Risikoeinschätzung und gezielte…
Multiple Sklerose beginnt oft lange vor der Diagnose
Goldstandard für Versorgung bei Multipler Sklerose

PARKINSON

Meilenstein in der Parkinson-Frühdiagnose
Parkinson-Erkrankte besonders stark von Covid-19 betroffen
Gangstörungen durch Kleinhirnschädigung beim atypischen Parkinson-Syndrom
Parkinson-Agenda 2030: Die kommenden 10 Jahre sind für die therapeutische…
Gemeinsam gegen Parkinson: bessere Therapie durch multidisziplinäre Versorgung