As we have written on this blog several times this year, a growing number of studies have suggested a link between problems with Depakote and lower I.Q., as well as other developmental delays, autism and potential birth defects/malformations. In the face of this mounting evidence, the FDA issued a warning this week about use of Depakote during pregnancy.
In a drug safety communication issued on May 6, the FDA has provided new warnings about the risk of Depakote problems for children exposed to the medication during pregnancy. The FDA has contraindicated the use of Depakote and other valproate-based medications for treatment of migrains by pregnant women, indicated that the risks for the child outweigh the benefits of preventing migrains.
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These warnings provide further support for the Depakote lawsuits being reviewed by our product liability lawyers, who are continuing to offer free consultations and claim evaluations for families of children who have experienced health issues that may have been caused by Depakote problems, including:
- Low I.Q.
- Cognitive Problems
- Developmental Delay
- Spina Bifida
- Cleft Palate
- Other Birth Defects or Malformations
Depakote Lower I.Q. Warning
The new FDA warnings were issued after the agency reviewed a recent study that indicates side effects of Depakote may lower I.Q. scores for children whose mother were prescribed the drug while pregnant. Therefore, the agency has changed the pregnancy category for Depakote migraine use from “D” (indicating that the potential benefit of the drug may be acceptable despite the risk) to a category “X” pregnancy drug (indicating that use of Depakote in pregnant women to treat migrains clearly outweighs the possible benefits).
Although the risk of I.Q. problems with Depakote appears to exist whether the drug is used to treat migrains or other conditions, the agency has maintained the pregnancy category D for Depakote use among epileptics and those suffering manic episodes associated with bi-polar disorder.
The agency has indicated that Depakote and other valproate-based drugs should only be prescribed if other medications were not effective and urges women of childbearing age to use effective birth control while taking Depakote.
Among the valproate drugs affected by the warning are:
- Depakote, Depakote CP and Depakote ER (divalproex sodium)
- Depacon (valproate sodium)
- Depakene and Stavzor (valproic acid)
Depakote I.Q. Lawsuits
The FDA indicates that it is working with the manufacturers to update the Depakote warning label to better describe the risk of lowered I.Q., and that it will continue to update the public as information becomes available.
It appears that the drug makers knew or should have known about the link between Depakote and I.Q. problems for some time, financial compensation may be available for children as a result of the failure to provide adequate information to women and the medical community.
To review a potential claim for yourself, a friend or family member who may have experienced problems from Depakote exposure, request a free consultation and claim evaluation.