EMA Calls for Withdrawal of Certain Anxiety Medications
January 20, 2012 — The European Medicines Agency (EMA) is recommending suspension throughout the European Union (EU) of all medicines containing meprobamate, a key ingredient in some anxiolytic medications.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of meprobamate do not outweigh its risks and that all marketing authorizations for oral medicines containing meprobamate be suspended throughout the EU.
A carbamate deriviative, meprobamate is used primarily to treat anxiety disorders, but according to the EMA, it is also used for migraine, digestive disorders, muscle tension or cramps, as well as insominia. It is marketed under the name Equanil and other trade names.
The EMA review of the meprobamate-containing medications was undertaken because of a July 2011 announcement by France's regulatory agency that it intended to suspend marketing authorizations of these agents because of "serious side effects."
After reviewing all available safety and efficacy data of the medications, including data from published studies, postmarketing surveillance, and poison control centers, the CHMP concluded 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 patient, including elderly people."
The CHMP also noted that there is a risk of addiction that can lead to "serious and sometimes fatal side effects" if patients stop the medication abruptly.
The final word on whether these medications are ultimately to be banned in Europe will be determined by the European Commission.
To avoid the risk of severe withdrawal symptoms and to ensure that 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 Committee decision.
In the meantime, the EMA recommends the following:
•Doctors should not start new patients on meprobamate-containing medicines.
•Doctors should review the treatment of patients currently taking meprobamate-containing medicines with a view to switching them to alternative treatments, in line with national recommendations for the condition being treated.
•Prescribers should be aware that the availability of meprobamate-containing medicines will decrease as the withdrawal from the market takes place according to national time frames.
January 20, 2012 — The European Medicines Agency (EMA) is recommending suspension throughout the European Union (EU) of all medicines containing meprobamate, a key ingredient in some anxiolytic medications.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of meprobamate do not outweigh its risks and that all marketing authorizations for oral medicines containing meprobamate be suspended throughout the EU.
A carbamate deriviative, meprobamate is used primarily to treat anxiety disorders, but according to the EMA, it is also used for migraine, digestive disorders, muscle tension or cramps, as well as insominia. It is marketed under the name Equanil and other trade names.
The EMA review of the meprobamate-containing medications was undertaken because of a July 2011 announcement by France's regulatory agency that it intended to suspend marketing authorizations of these agents because of "serious side effects."
After reviewing all available safety and efficacy data of the medications, including data from published studies, postmarketing surveillance, and poison control centers, the CHMP concluded 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 patient, including elderly people."
The CHMP also noted that there is a risk of addiction that can lead to "serious and sometimes fatal side effects" if patients stop the medication abruptly.
The final word on whether these medications are ultimately to be banned in Europe will be determined by the European Commission.
To avoid the risk of severe withdrawal symptoms and to ensure that 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 Committee decision.
In the meantime, the EMA recommends the following:
•Doctors should not start new patients on meprobamate-containing medicines.
•Doctors should review the treatment of patients currently taking meprobamate-containing medicines with a view to switching them to alternative treatments, in line with national recommendations for the condition being treated.
•Prescribers should be aware that the availability of meprobamate-containing medicines will decrease as the withdrawal from the market takes place according to national time frames.
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