Stavzor Gets Boxed Warning for Deadly Liver Failure Risk

April 14, 2014 — Stavzor (valproic acid) has been linked to deadly liver failure, according to a Boxed Warning from the U.S. Food and Drug Administration (FDA).

Children under the age of two are considerably more likely to develop fatal hepatotoxicity — especially those with certain risk-factors — and the risk goes down for older patients.

Liver damage is most likely during the first six months of treatment. Therefore, doctors should be cautious when prescribing Stavzor to patients with a history of liver problems.

According to the FDA:

“Hepatic failure resulting in fatalities has occurred in patients receiving valproic acid. These incidents usually have occurred during the first six months of treatment. Serious or fatal hepatotoxicity may be preceded by non specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting. In patients with epilepsy, a loss of seizure control may also occur.”

The problem affects all anti-seizure drugs that contain valproic acid, such as Depakote. These drugs have also been linked to an increased risk of birth defects when they are used during pregnancy — cleft palate, abnormal skull development, spina bifida, heart defects, and more.

The FDA restricted the use of valproic acid during pregnancy in May 2013. The FDA also changed the pregnancy category to a class “X,” but only when the drugs are used to treat migraine headaches. Doctors can still prescribe Stavzor to a pregnant woman if the benefits for the mother outweigh the risks to a fetus.

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