EMA Calls for Withdrawal of Marketing Authorizations for Oral Meprobamate-Containing Medicines

Posted 20 January 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) today called on EU national regulatory authorities, including France, UK and Italy, to withdraw their respective Marketing Authorizations (MA) for oral meprobamate-containing medications. The medication has been associated with severe side effects including overdose, coma and death.

Meprobamate is a prescription sedative medicine used to treat anxiety, alcohol withdrawal, migraine attacks, disgestive disorders, muscle tensions, muscle cramps and insomnia. It is currently available in France, the Netherlands, Finaland, Hungary, Italy, Romania, UK, Iceland and Norway.

The French regulatory authority, Afssaps, alerted EMA in July of 2011 that they intended to suspend the MA for meprobamate because of the long list of side effects, including confusion, loss of consciousness, addiction, severe withdrawal symptoms, overdose, coma and death.

After reviewing the medication, EMA's Committee for Medicinal Products for Human Use (CHMP) concluded that "the benefits of meprobamate do not outweigh its risks", and recommended that all national authorities remove meprobamate from the market gradually over the next 15 months. CHMP further recommended that doctors stop prescribing the medication due to the unfavorable risk-benefit assessment.

Severe withdrawal symptoms are associated with stopping oral meprobamte-containing medications too quickly, and the CHMP found the difference between an adequate treatment dose and an overdose to be minor.

EMA's notice said that the European Commission will issue a decision on their opinion "in due course."



Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe