Thread: Depakote
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Old May 19, 2015, 02:33 PM
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Hexagram Hexagram is offline
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Member Since: Jan 2015
Location: The Mixed States of America, 96816
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I take 1500 mg of Depakote. I don't know what the NHS told you, but you should know that

Quote:
The FDA requires Depakote to carry a black-box warning because it can cause serious liver damage that could be fatal. The risk of this happening is higher in the first six months of taking the drug. In some cases liver damage continued even after patients stopped taking Depakote.

There is an additional black-box warning linking Depakote to cases of life-threatening pancreatitis. In some cases, patients who developed pancreatitis rapidly went from initial symptoms to death, so getting medical treatment quickly is essential.
Quote:
A black box warning is the strictest warning put in the labeling of prescription drugs or drug products by the Food and Drug Administration (FDA) when there is reasonable evidence of an association of a serious hazard with the drug. It is basically a warning with a black box around it, hence the name. Having the black box around the warning means that an adverse reaction to the drug may lead to death or serious injury. It's based on clinical data or serious animal toxicity data in the absence of clinical data. Sometimes a black box warning is necessary at the time a new drug is approved. More commonly however, it is added after the drug has been approved and the FDA has received reports of adverse events. After the FDA confirms the serious risk, then depending on the severity of adverse event and in collaboration with the pharmaceutical company, a boxed warning is implemented. This does not mean the drug is contraindicated in any way, but just a means of communication from the FDA to prescribers to highlight the risk. As with any drug, there is a risk and benefit associated with taking the drug. The black box warning is to alert prescribers of the potential risk in prescribing this drug so they can take it into consideration.
Thanks for this!
Toodles333