Sanofi removed a website for epilepsy drug Epilim after a consumer complaint. The Medicines and Healthcare products Regulatory Agency (MHRA) investigated the complaint that the Sanofi website for healthcare professionals did not adequately balance treatment risks especially for childbearing-age women.
After MHRA contacted Sanofi, the pharma decided to remove the entire website, because the same material can be found on other digital platforms. With Sanofi’s action, MHRA dropped the investigation, although it also “reminded Sanofi of the importance of keeping information up to date.”
Sanofi was not immediately available for comment.
Called Epilim in the U.K., sodium valproate is used to treat epilepsy and bipolar disorder as well as migraines in adults 18 and older. However, significant risk of birth defects are associated with the drug along with other valproates including Depakine, also marketed by Sanofi in Europe, AbbVie's Depakote and other generic brands.
Women who use the medicines during pregnancy run the risk of children’s birth defects including physical malformations such as small fingers and toes, spina bifida and cleft palate as well as developmental delays.
The MHRA banned the used of valproates for girls and women of childbearing age in 2018, unless they’re enrolled in a pregnancy prevention program.
Sanofi has faced lawsuits in France related to Depakine over allegations it did not properly warn pregnant patients of the risk. AbbVie has faced similar suits around Depakote in the U.S.
In 2019, Epilim made headlines for a U.K. drug shortage caused by a plant manufacturing halt to address pollution issues. At the time, Sanofi reassured patients and the public that the shortage was not related to the then-pending Brexit breakup of the U.K. and the EU.