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Stavzor Liver Failure Risk Highlighted in FDA Boxed Warning

Stavzor Liver Failure Risk Highlighted in FDA Boxed Warning

April 14, 2014 — The U.S. Food and Drug Administration (FDA) has published a Boxed Warning for Stavzor (valproic acid) about the risk of deadly liver failure.

Liver failure is considerably more likely in children under two years old — especially those with risk-factors (using multiple anti-convulsant drugs, congenital metabolic disorders, brain disease, and seizure disorders accompanied by mental retardation).

Liver failure is also more common during the first six months of treatment with Stavzor. The risk decreases significantly for older patients.

The FDA will add the following Black Box Warning label to the Prescribing Information for Stavzor:

“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 FDA has also restricted the use of Stavzor and valproic acid during pregnancy. The drugs are “Pregnancy Category X” for the treatment of migraines because they can significantly increase the risk of having a baby with a birth defect — cleft palate, skull defects, spina bifida, heart defects, and more. However, Stavzor can still be prescribed to a pregnant woman if a doctor determines that the benefits to the mother outweigh potential risks to a fetus.

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The Schmidt Firm, PLLC is currently accepting Stavzor induced injury cases in all 50 states. If you or somebody you know has been injured by Stavzor, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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