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EMA calls for meprobamate sedatives to be suspended

Pfizer’s Equanil among medicines said to carry risk of serious side effects

European regulators have recommended suspending the use of medicines containing the sedative meprobamate due to their risk of serious and potentially fatal side effects.

Meprobamate has been associated with a number of unwanted effects, including confusion, loss of consciousness, addiction, severe withdrawal symptoms, overdose, coma and even death and drugs affected by the European Medicines Agency's (EMA) recommendation include Pfizer's Equanil and Wallace Laboratories' Miltown.

The EMA began its review in the second half of 2011 following a decision from the French drug regulator, Afssaps, to suspend use of oral meprobamate products after mounting concern about the drug's side effects.

Following its own review of safety and efficacy data, the EMA's Committee for Medicinal Products for Human Use (CHMP) also determined that the risks of meprobamate did not outweigh the benefits.

The CHMP concluded the risks were amplified due to the danger of unintentional overdose, with only a small difference between the treating and harmful doses of the medicine.

Problems with addiction were also noted by the CHMP, with patients suffering serious side effects if treatment was stopped abruptly after use over a long period of time.

With this in mind, doctors are suggested to stop prescribing meprobamate-containing medicines over the next 15 months and consider alternative treatments in line with national recommendations.

The EMA's meprobamate recommendations have been passed to the European Commission (EC), which will make the final decision on the medicines.

23rd January 2012

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