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Did you know there was a Depakote recall in 2006 and in 2009?

Depakote was approved by the FDA on March 10, 1983, and a generic version (divalproex sodium) was released on July 29, 2008. (1) Depakote was initially used as an anti-epileptic treatment. Its other on-label uses now include mania prevention for patients with bipolar disorder and migraine prevention. (2) However, Depakote's benefits are sometimes outweighed by its risks.

The Depakote recall of 2006 and the Depakote recall of 2009 were issued for separate reasons. The FDA lists the reason for the 2006 recall as “mispacked,” elaborating that “correct labeled product may be mispacked.” (3) The 2009 Depakote recall was attributed to “non-conformance with current Good Manufacturing Practices.” The Depakote recall affected Arkansas, Georgia, Illinois, Louisiana, Mississippi, Missouri, Oklahoma and Texas. (4)

The Depakote recalls, though upsetting, are not as disturbing as the known side effects and risk of birth defects related to Depakote. Weitz & Luxenberg has been able to help many people who have been irreversibly harmed by faulty medical devices and dangerous drugs. If you or someone close to you have been negatively affected by Depakote, you have legal options.

Should there be a complete Depakote recall?

Do recalls of risky products have to be preceded by disasters? What if, going on the knowledge the FDA and researchers have about the teratogenic risks (harm to an unborn child) and the risks of liver damage, the government issued a recall unprompted by any disaster?

The problem with a recall of Depakote and its many generic forms is that it has been useful in preventing migraines, preventing manic episodes in those who suffer from bipolar disorder, and in preventing seizures both petit and gran mal. When a drug is effective in treating difficult illnesses such as epilepsy and bipolar disorder, there is a great reluctance to recall it, though it is known to cause serious side effects.

But spina bifida is a serious illness as well, and in 2010, researchers foundsignificant associations between Depakote use while pregnant and spina bifida, atrial septal defect, cleft palate, hypospadias, polydactyly, and craniosynostosis. Risks for five of these conditions were 2 to 7 times as high for exposed fetuses, and the risk for the sixth condition, spina bifida, was 12 or 16 times as high.” (6)

Doctors always have to measure risks and benefits when prescribing medications that have the risk of severe side effects. It is very difficult to decide when a drug's risks are too large to justify its usage, and only the future will tell what the FDA decides about Depakote and other anti-epileptic drugs.

Would a Depakote recall have helped prevent your illness or your child's illness?

If you have been harmed by Depakote and are interested in learning more about your legal options, contact Weitz & Luxenberg at 1-800-476-6070, or fill out a form for a free legal consultation. You do not have to go through this alone.

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Depakote and Pregnancy

If you take Depakote, pregnancy can be perilous
When taken during pregnancy, Depakote can cause birth defects including spina bifida. Visit Weitz & Luxenberg for more information.

Was Depakote Recalled?

Learn about the Depakote recall in 2006 and 2009, and other Depakote FDA news
the FDA did not recall Depakote, but it did issue a warning to avoid taking it during pregnancy due to the risk of birth defects such as spina bifida.

Depakote

Have you or your child experienced Depakote side effects?
Depakote is associated with several side effects. However, if you took Depakote while pregnant, you child could be at risk for birth defects.

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