Tue, Jun 25, 2019 - Page 2 News List

FDA to tighten valproate controls

PREGNANCY ISSUES:Other countries have endorsed more stringent regulations, so the agency discussed the issue and concluded that Taiwan should follow suit

By Lee I-chia  /  Staff reporter

The Food and Drug Administration (FDA) yesterday announced plans to tighten controls over the use of medicine containing valproate among pregnant women and women of childbearing age.

Valproate is a treatment for epilepsy, bipolar disorder and can prevent migraines, but studies show that for women who take it during pregnancy, there is significant risk of defects and developmental disorders to their children.

The FDA in 2013 prohibited doctors from prescribing valproate to pregnant women as migraine prophylaxis, and when they are prescribed to pregnant women to treat other conditions because there is no alternative, they should be warned about the risk of their child being born with congenital abnormalities or disorders.

FDA Medicinal Products Division section chief Hung Kuo-teng (洪國登) said that as several countries endorsed more stringent regulatory controls of valproate medicine, the FDA’s drug safety and evaluation advisory group discussed the issue and concluded that Taiwan should follow suit.

From yesterday, doctors are banned from prescribing valproate to pregnant women to treat bipolar disorder; are barred from using it to treat epilepsy in pregnant women unless there is no alternative; and are banned from using it to treat epilepsy or bipolar disorder in women of childbearing age unless they are using reliable contraception methods, Hung said.

Doctors should evaluate the possibility of pregnancy in female patients of childbearing age, and fully explain the risks of birth defects and other risks to the fetus if valproate is taken during pregnancy before they prescribe the drug, the FDA said.

Women who are taking valproate when they become pregnant should consult a doctor immediately, it said.

If people suspect an adverse reaction to drugs, it can be reported to the FDA’s hotline on (02) 2396-0100, it said.

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