UK bans Sanofi epilepsy drug without pregnancy prevention plan

LONDON: A Sanofi drug for epilepsy and bipolar disorder linked to thousands of birth defects has been banned in Britain for use in women or girls of child-bearing age unless they are on a special pregnancy prevention program.

The move follows a scandal over the lack of information given to patients about the risks associated with valproate, which was first approved in France in 1967 and remains a widely used treatment for epilepsy.

It is sold by Sanofi under the brand Depakine for epilepsy and Depakote and Depamide for bipolar disorders. It is also available in generic versions.

The action by the UK Medicines and Healthcare products Regulatory Agency (MHRA), announced on Tuesday, follows a European recommendation for tighter controls last month.

It means that women must comply with contraception throughout treatment, undergo pregnancy testing if asked and sign a form acknowledging the risk of taking the drug every year.

Other countries in Europe are talking with local authorities to implement similar measures and Sanofi said it would work to ensure the effective roll-out of the new risk-reduction steps.

Sanofi is now working to produce smaller pack sizes to encourage monthly prescribing and is also adding a pictogram warning image on its valproate labeling.