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FDA orders doctors to stop prescribing drugs linked to birth defects

2019/06/24 17:59:08

Image taken from Pixabay for illustrative purpose only

Taipei, June 24 (CNA) Doctors in Taiwan have been instructed to stop prescribing valproate-containing medicines, which are primarily used to treat epilepsy, bipolar disorder and prevent migraines, to pregnant women in the wake of growing evidence that links valproate to birth defects, the Food and Drug Administration (FDA) announced Monday.

From Monday, the use of valproate-containing medicines during pregnancy will not be allowed for women with bipolar disorder, and only permitted for pregnant women with epilepsy if no other treatment is effective, the FDA said, citing recent studies that show fetuses exposed to valproate medicines in the womb are at risk of malformations and developmental problems.

FDA division chief Hung Kuo-teng (洪國登) told CNA that the administration banned valproate to treat migraines in 2013, adding that a warning about related pregnancy risks, including birth defects, has been printed on the packaging of such medicines since then.

The partial ban on the use of the medicines during pregnancy from Monday was made in the wake of more countries imposing stricter restrictions since 2018, he said.

A summary published on March 28, 2019, by the National Institute for Health and Care Excellence, an executive non-departmental public body of the Department of Health in the United Kingdom, said children born to women who take valproate during pregnancy are at significant risk of birth defects and persistent developmental disorders.

If valproate is taken during pregnancy, up to four in 10 babies are at risk of developmental disorders, and approximately one in ten at risk of birth defects, the summary said.

European Medicines Agency, a European Union body that evaluates and supervises medicine products in all member states agreed to ban the use of such medicines for migraines and bipolar disorder during pregnancy in 2018.

The FDA urged pregnant women taking valproate medication to consult with their doctor.

Any girl or woman prescribed valproate should also be fully informed of the risks during pregnancy associated with the medication, it said.

(By Chen Wei-ting and Chung Yu-chen)