During its February meeting, the European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) recommended new measures to avoid valproate exposure in pregnant women, owing to the risks for malformations and developmental problems.
The recommendations include new restrictions on use, a pregnancy prevention program, and valproate product package changes.
Valproate (Depacon, AbbVie) is approved in Europe to treat bipolar disorder and epilepsy and, in some countries, to treat migraine. In 2014, the EMA conducted a safety review of valproate, owing to an increased risk for malformations and developmental problems after fetal exposure to the drug.
After the 2014 assessment, the CMDh (Coordination Group for Mutual Recognition and Decentralised Procedures–Human), a European regulatory body representing EU member states, strengthened warnings on valproate to better inform women of the risks of valproate use in pregnancy.
Last year, the EMA launched a new safety review because of concerns that these measures had not been sufficiently effective.
On the basis of this review, the PRAC has concluded that women still do not always receive appropriate information about valproate in a timely manner and that further measures are needed to reduce use during pregnancy.
Specifically, the PRAC recommended that in countries where valproate is approved for the treatment of migraine, bipolar disorder, or epilepsy, the drug must not be used during pregnancy. However, the PRAC recognized that for some women with epilepsy, it may not be possible to withhold valproate and that for such patients, treatment may have to continue, with appropriate specialist care, during pregnancy.
The PRAC further recommended that valproate not be used in women from the time they enter childbearing age unless the conditions of a new pregnancy prevention program are met.
The key components of the valproate pregnancy prevention program include the following:
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Assessing patients for the potential of becoming pregnant, involving the patient in evaluating her individual circumstances, and supporting informed decision making.
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Conducting pregnancy tests before starting and during treatment as needed.
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Counseling patients about the risks of valproate treatment and explaining the need for effective contraception throughout treatment.
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Conducting reviews of treatment by a specialist at least annually and completing a risk acknowledgement form with patients at each review to confirm that appropriate advice has been given and understood.
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The PRAC also recommended that the outer packaging of all valproate medicines include a visual warning about the risks in pregnancy. “In addition to boxed text, this may include a symbol/pictogram, with the details to be adapted at national level,” the EMA said.
The PRAC also recommended that a patient reminder card be attached to the outer package, which pharmacists may discuss with the patient each time the medicine is dispensed. Companies that market valproate should also provide updated educational materials in the form of guides for healthcare professionals and patients.
The PRAC recommendations will now be sent to CMDh, which will adopt a position.
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