3 ms·
For such an old drug, I'm surprised that the FDA didn't classify it as Pregnancy Category D (don't take it) until 2013. https://www.fda.gov/drugs/drug-safety-a
by cko 3y ago
For such an old drug, I'm surprised that the FDA didn't classify it as Pregnancy Category D (don't take it) until 2013.
https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-valproate-anti-seizure-products-contraindicated-migraine-prevention https://www.fda.gov/drugs/drug-safety-and-availability/fda-d...
- verisimi 3y agoWhy? These organisations only purport to be acting for 'the people' whilst actually working for the pharmaceutical organisations. They are there to provide the illusion of safeguards.
- giantg2 3y agoBecause the other epilepsy drugs carry similar risks. So they leave it as an option since the individual risk profile depends on the effectiveness and efficacy of the other drugs for that specific person. Even the "safe" standard (keppra) has these risks today.
- Turing_Machine 3y agoThat's just for the effects on child IQ, which apparently came out of a new study around that time. It says at the bottom that the other fetal risks have been known for a long time. "Valproate products have long been known to increase the risk of serious birth defects, in particular, neural tube defects such as spina bifida. This risk is already described in detail in the drug labels for valproate products."