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Depakote: A Brief History

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Portland, ORSince 1983, Depakote has been marketed in the United States as a medication for the treatment of epilepsy. More than two million Americans have some form of epilepsy, and 125,000 new cases of epilepsy are reported each year. For the drug maker, Abbott Laboratories, sales were brisk, but there were other markets to tap into - also known as "off-label" use.

Depakote has since become the most-prescribed drug (surpassing lithium) for treating manic episodes associated with bipolar disorder, also known as manic depression. Lithium was the only FDA-approved drug for mania until Depakote was approved in May, 1995.

March 28, 1996: The FDA approved Abbott Laboratories' Depakote(R) (divalproex sodium) tablets for the prevention of migraine headaches.

With approximately 23 million Americans suffer from migraine headaches, this approval was a windfall for Abbott. The drug company maximized Depakote by advising migraine patients to take the medication "daily to reduce the frequency of migraine headaches," said Andre Pernet, Ph.D., vice president, pharmaceutical research and development, Abbott Laboratories.

September 1, 2000: After reports of life-threatening pancreatitis, the FDA required black box warning revision for Abbott Pharmaceuticals Depakote Tablets (divalproex sodium delayed-release tablets), indicated for treating manic episodes; Depakote Sprinkle Capsules (divalproex sodium coated particles in capsules), and Depacon (valproate sodium injection), indicated for treating patients with complex partial seizures; and Depakene (valproic acid capsules and syrup), indicated for treating patients with seizures. In a recent letter, Abbott describes some of the cases as hemorrhagic with a rapid progression from initial symptoms to death.

December 20, 2002: Abbot announced that the FDA approved Depakote(R) ER (divalproex sodium extended-release) tablets for sole and adjunctive therapy to treat seizures in adults with epilepsy. It also announced that Depakote ER was approved for migraine prevention in 2000.

January 31, 2007: The FDA approved further safety labeling revisions to advise of the risk for congenital malformations in infants exposed to Depakote during gestation. Depakote is now classed as "Category C" for pregnant women, meaning that animal studies have shown an adverse effect and that there are no adequate and well-controlled studies in pregnant women.

Even with label changes warning of risks associated with Depakote, it is one of the most-prescribed off-label drugs and widely prescribed. It is taken by patients who may be taking several other medications at the same time, by children under 10 years of age, and by pregnant women.

Hepatic failure resulting in fatalities has occurred in patients receiving Depakote, usually during the first six months of treatment. Also known as valproate, the drug may produce malformations in the fetus of women taking Depakote during pregnancy.

Benefits of using Depakote and Depakote ER in migraine treatment should be weighed against risk of injury to the fetus in women of childbearing potential. Cases of life-threatening pancreatitis, some rapidly progressing to death, have been reported in both adults and children receiving valproate.

Because bipolar disorder (manic-depressive illness) is a common and highly recurrent disorder requiring lifelong treatment, many women of childbearing age are maintained on mood stabilizers (such as lithium) and the anticonvulsant Depakote (valproic acid).

Both drugs are teratogenic, so women with bipolar disease have typically been counseled to defer childbearing or abruptly stop their medications when they get pregnant.

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Depakote Legal Help

If you or a family member have taken Depakote and have subsequently had a child with birth defects, please contact a [Depakote] lawyer who will evaluate your claim at no charge.

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