UK bans Sanofi epilepsy drug without pregnancy precautions

Apr 25, 2018

Officials in the UK have banned the use of a common drug for epilepsy and bipolar disorder in women of child-bearing age, unless they take measures to prevent pregnancy.

The drug, valproate, has been linked to at least 20,000 cases of birth defects in the UK alone since it was approved in the 1970s.

Earlier this month, officials in the EU signaled the need for tighter restrictions on valproate. Now the UK Medicines and Healthcare products Regulatory Agency has issued new rules stating that female patients can only use the drug if they sign a form acknowledging the risks of taking valproate when pregnant, make yearly visits to discuss the risks with their doctor, are given contraception options and take pregnancy tests if show pregnancy symptoms.

The FDA issued a warning about valproate in 2011, advising women to seek alternative treatments if they may become pregnant.

Read the full BBC report.