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> They also found the response from the Committee on Safety of Medicines (CSM), then the main decision-making body on new medicines, which concluded that the ri
by Turing_Machine 3y ago
> They also found the response from the Committee on Safety of Medicines (CSM), then the main decision-making body on new medicines, which concluded that the risk was low and that patients should not be informed, in order to avoid “fruitless anxiety”.
That's interesting, because in the United States this stuff has a "black box warning" that warns in no uncertain terms about fetal risk.
http://editor.fresenius-kabi.us/PIs/US-PH-Valproate-Sodium-Inj-FK-45982G-10-2015-PI.pdf http://editor.fresenius-kabi.us/PIs/US-PH-Valproate-Sodium-I...