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Black Box Warning Regarding Increased Risk of Liver Failure and Death Added to Stavzor Product Label

In March 2014, the manufacturers of Stavzor added a Black Box Warning, which is the strongest type of warning, to the product label regarding the increased risk of liver failure and death. The Black Box Warning for Stavzor reads: “Hepatotoxicity, including fatalities, usually during first 6 months of treatment. Children under the age of two years and patients with mitochondrial disorders are at high risk. Monitor patients closely, and perform serum liver testing prior to therapy and at frequent intervals thereafter.” This Black Box Warning for Stavzor comes nearly one year after an almost identical Black Box Warning was added to other valproate products, including Depakote, Depacon, and Depakene.

Valproate products, such as Depakote (divalproex sodium), are medications used to treat epileptic seizures, manic episodes associated with bipolar disorder, and the prevention of migraine headaches. Valproate products include: valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), and valproic acid (Depakene and Stavzor). The FDA reports that within the outpatient setting in 2012 alone, approximately 1.5 million patients received a prescription for valproic acid and derivative products, and approximately 22% (341,000 patients) of total patients were women of reproductive age (between 13-45 years old).

In June 2011, the FDA issued a Safety Announcement “informing the public that children born to mothers who take the anti-seizure medication valproate sodium or related products (valproic acid and devalproex sodium) during pregnancy have an increased risk of lower cognitive test scores than children exposed to other anti-seizure medications during pregnancy.” The FDA reported that “[t]his conclusion is based on the results of epidemiologic studies that show that children born to mothers who took valproate sodium or related products throughout their pregnancy tend to score lower on cognitive tests (IQ) and other tests) than children born to mothers who took other anti-seizure medications during pregnancy.”

In May 2013, the FDA issued another Safety Announcement “advising health care professionals and women that the anti-seizure medication valproate sodium and related products, valproic acid and divalproex sodium, are contraindicated and should not be taken by pregnant women for the prevention of migraine headaches.” In particular, the FDA reported that “[b]ased on information from a recent study, there is evidence that these medications can cause decreased IQ scores in children whose mothers took them while pregnant.”

Most recently, the issue has turned to the increased risk of liver failure, hepatotoxicity, and death associated with the use of these products, as evidenced by the recent Black Box Warnings added to the product labels of these drugs.

 

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