EMA recommends restricting use of tolperisone medicines

 

Benefit-risk profile for oral tolperisone considered positive only for adults with post-stroke spasticity and negative for injectable tolperisone

 

London, UK (June 22, 2012) – The European Medicines Agency has recommended restricting the use of tolperisone, a muscle relaxant authorised to treat a variety of different conditions, including spasticity due to neurological disorders and muscle spasms associated with diseases of the spine and large joints in several European Union countries since the 1960s.

 

The review by the Agency’s Committee for Medicinal Products for Human Use (CHMP) was initiated by Germany following concerns over several hypersensitivity reactions reported post marketing and insufficiently demonstrated efficacy in some indications. Taking into account that the risk of hypersensitivity reactions is more significant than previously identified and due to uncertainties in relation to its efficacy in the different indications, the Committee concluded that the benefits of tolperisone outweighed its risks only in the treatment of adults with post-stroke spasticity and only when used as an oral formulation.

 

Doctors should stop prescribing tolperisone for any other indication than post-stroke spasticity in adults. They should also no longer use injectable tolperisone.
Patients currently using tolperisone for any other indication or using injectable tolperisone should speak to their doctor at their next routine appointment so they can switch to an appropriate alternative treatment.

 

Patients should be made aware of the possibility of developing hypersensitivity reactions during treatment with tolperisone. They should stop treatment with tolperisone and speak to their doctor if they experience symptoms such as flushing, rash, severe itching of the skin (with raised lumps), wheezing, difficulty breathing, difficulty in swallowing, fast heartbeat, low blood pressure or fast decrease in blood pressure.

 

The CHMP’s opinion will be sent to the European Commission for the adoption of a binding decision throughout the European Union

 

 

Notes 

  1. This press release, together with all relevant documents is available on the Agency’s website.
  2. Tolperisone-containing products are currently approved in the following EU countries: Austria, Bulgaria, Cyprus, Czech Republic, Germany, Hungary, Latvia, Lithuania, Poland, Romania and Slovak Republic.
  3. The review of tolperisone-containing medicines was conducted in the context of a formal review under Article 31 of Directive 2001/83/EC, initiated at the request of Germany.
  4. More information on the work of the European Medicines Agency can be found on its website: www.ema.europa.eu

 


European Medicines Agency (EMA), 22.06.2012 (tB).

MEDICAL NEWS

COVID-19 vaccines are estimated to have prevanented 20 million deaths…
Novel sleep education learning modules developed for nurse practitioners
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…

SCHMERZ PAINCARE

Aktuelle Versorgungssituation der Opioidtherapie im Fokus
Individuelle Schmerztherapie mit Opioiden: Patienten im Mittelpunkt
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…

DIABETES

Typ-1-Diabetes: InRange – auf die Zeit im Zielbereich kommt es…
Suliqua®: In komplexem Umfeld – einfach besser eingestellt
Suliqua®: Überlegene HbA1c-Senkung  im Vergleich zu Mischinsulinanalogon
„Wissen was bei Diabetes zählt: Gesünder unter 7 PLUS“ gibt…
Toujeo® bei Typ-1-Diabetes: Weniger schwere Hypoglykämien und weniger Ketoazidosen 

ERNÄHRUNG

Mangelernährung gefährdet den Behandlungserfolg — DGEM: Ernährungsscreening sollte zur klinischen…
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

ONKOLOGIE

Krebspatienten unter Immuntherapie: Kein Hinweis auf erhöhtes Risiko für schwere…
WHO veröffentlicht erste Klassifikation von Tumoren im Kindesalter
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!

MULTIPLE SKLEROSE

Multiple Sklerose durch das Epstein-Barr-Virus – kommt die MS-Impfung?
Neuer Therapieansatz für Multiple Sklerose und Alzheimer
„Ich messe meine Multiple Sklerose selbst!“ – Digitales Selbstmonitoring der…
Stellungnahme zur 3. Impfung gegen SARS-CoV2 bei Personen mit MS
NMOSD-Erkrankungen: Zulassung von Satralizumab zur Behandlung von Jugendlichen und Erwachsenen

PARKINSON

Alexa, bekomme ich 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…