The ANSM prohibits the use of beta-2 mimetics to prevent premature births. The drug has serious cardiovascular risks.
Beta-2 mimetic bronchodilators should not be used to delay labor in pregnant women. The warning comes from Medicines Safety Agency (ANSM) which announces this December 3 the conclusions of the European re-evaluation of these drugs. Their benefit-risk ratio, according to the European Medicines Agency (EMA), is unfavorable.
The EMA believes that long-acting oral and rectal beta-2 mimetics have high risks of serious cardiovascular disorders with limited efficacy. This re-evaluation follows an alert from the American Health Security Agency, the FDA, in 2012. The Pharmacovigilance Risk Assessment Committee (PRAC) confirms the risks described by the FDA: cardiac arrhythmia, myocardial ischemia, infarction myocardial, pulmonary edema. The drugs concerned should therefore no longer be used to treat threats of premature delivery, warns the ANSM.
In obstetrics, beta-2 mimetics are traditionally used to prevent or treat the risk of preterm birth. Those of short action should not exceed 48 hours of treatment. However, certain uses may be maintained. This is the case during hospitalization limited to 48 hours, in a hospital environment and under medical supervision. The ANSM nevertheless restricts treatment to threats of premature delivery without complications and prohibits it to women less than 22 weeks pregnant or exposed to a cardiovascular risk.
Injectable and inhalable forms of beta-2 mimetics are not included in this reassessment. This warning only concerns the obstetric use of this medication, which is also used to treat asthma and chronic obstructive pulmonary disease. Finally, any woman taking oral or rectal treatment should not stop it before talking to her doctor or the midwife who follows her during her pregnancy.
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