A Sanofi manufacturing facility in France, which was temporarily closed five years ago for emitting dangerous emissions, is under the microscope again after a recent leak caused the release of the same neurotoxin, bromopropane.
The plant, which produces epilepsy drug Depakine (sodium valproate), released 75 times the allowable amount of bromopropane in mid-November, according to a report in the French news outlet Le Monde.
The facility, located in Mourenx, stopped production “immediately" after noting “inconsistent measurements” of bromopropane emissions, according to a Sanofi spokesperson.
“We quickly identified that this isolated and very brief event was linked to the degradation of the treatment unit’s activated carbons following the bad weather and heavy rains that had affected the region in the preceding days,” Sanofi said. “The coals were replaced and bromopropane emissions returned to normal, enabling production to resume after approval from the authorities.”
Bromopropane—which is used in the production of Depakine—is classified as a possible carcinogen by the World Health Organization. Manufacturers using bromopropane are required to self-monitor their emissions of the neurotoxin.
The drug itself, Depakine, has been under the microscope in France for years. In 2020, France launched an investigation into alleged safety risks for babies when valproate is taken by pregnant mothers. The company has denied the charges.
Last month, Le Monde reported that a woman in France, who never took Depakine but has worked next door to the plant since 2011, filed a complaint against Sanofi, saying that her two epileptic children—who were born in 2014 and 2016—have disorders similar to those shown in children whose mothers took the drug during pregnancy.
In 2018, after the plant was shut down, French officials continued their scrutiny of the Mourenx facility. In August 2022, a public health investigation was launched, ramping up pressure on the site to remain compliant.