The European Medicines Agency said this week that it’s looking into data — retrospective observational data that need to be corrected by the company that ran the study, IQVIA — on the potential risk of neurodevelopmental disorders (NDDs) in children conceived by fathers taking valproate medicines.
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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.
NICE to reinforce the importance of collaborative working with system partners to ensure a more integrated approach to safety recommendations made in NICE guidance
French pharmaceutical firm Sanofi is being investigated for possible manslaughter charges in France over the deaths of four babies whose mothers took the anti-epilepsy drug valproate.
Sanofi has been formally charged over Depakine — a decades-old therapy for epilepsy that causes birth defects and impedes neurological development when taken during pregnancy.
In a bid to promote patient safety, the Drugs Controller General of India (DCGI) has directed all state drug controllers in the country to take steps to ensure that manufacturers of seven formulations-- cefotaxime, ofloxacin, tranexamic acid, quetiapine, sulfasalazine, sodium valproate and cefixime-- mention newly identified adverse reactions in the package insert of the drugs.
Sanofi has restarted production at a plant where manufacturing had to be halted to fix pollution issues. The interruption created spot shortages of seizure drugs Epilim and Depakote in some markets, but Sanofi has assured patients it has nothing to do with the impending divorce of the U.K. and the European Union.
UK stockpiles drugs as no-deal Brexit feared