The Food and Drug Administration has issued two new warnings about an increased risk of side effects for patients taking drugs containing valproate (valproic acid), including Depakote, Depakene, Depacon, and Stavzor. Valproate medications can be prescribed to treat migraines, as well as epilepsy or bipolar disorder.
In a June 2013 warning, the FDA stated that the use of valproate drugs could cause birth defects and other developmental problems when used by pregnant women. The FDA warned in July 2013 that patients with mitochondrial disease who use valproate could face an increased risk of acute liver failure.
According to the FDA’s warning, pregnant women who take medications containing valproate are four times more likely to give birth to a child with birth defects. The use of valproate by pregnant women has been linked to cases of neural tube defects such as spina bifida, craniofacial defects, heart defects, and birth defects affecting other parts of the body. The FDA also warned that valproate medications could cause lower IQ scores when the drugs are taken by women while they are pregnant.
The FDA stated that valproate should not be used to treat pregnant women with migraine headaches due to the increased risk of birth defects the drugs may cause. The agency said that valproate should only be prescribed to pregnant patients with bipolar disorder or epilepsy in cases where other medications have failed to treat their condition.
In a separate warning, the FDA said that valproate could lead to hepatoxicity (liver failure) for patients with a certain time of mitochondrial disorder. The use of valproate among patients with hereditary neurometabolic syndromes caused by DNA mutations of the mitochondrial DNA Polymerase y (POLG) gene—such as Alpers Huttenlocher Syndrome—could lead to acute liver failure and death, according to the agency’s warning. Based on this information, the FDA says that valproate should not be used for patients with this type of mitochondrial disorder, as well as with patients under two years of age who are suspected of having a mitochondrial disorder.
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If you or a loved one has been affected by complications from valproate or other pharmaceuticals, you may be eligible to file a lawsuit and seek compensation. For a free consultation and to find out if you are eligible to file a lawsuit, please call us toll-free at 1-877-446-9001 or complete the free case evaluation form located on this page.