Attorney John J. Driscoll Comments on New FDA Warning about Depakote Birth Defects Risks

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The lawyer and consumer rights advocate from the Driscoll Firm, P.C., points to a study cited by the FDA, indicating a connection between pregnant women using migraine headache medications such as Depakote and decreased intelligence in their children. He urges consumers to review the FDA warning and learn more about their legal rights.

Nationally recognized drug injury lawyer discusses FDA warning about Depakote and similar migraine headache medications

John J. Driscoll

As a lawyer dedicated to protecting the rights of consumers, I am troubled by this new warning. Of course, our firm expects that women who have used Depakote while pregnant are concerned as well.

John J. Driscoll, an attorney who represents drug injury victims across the nation, today called consumers’ attention to a new U.S. Food and Drug Administration (FDA) warning about birth defect risks associated with Depakote and similar migraine headache medications.

According to the May 2013 FDA warning, valproate products such as Depakote (divalproex sodium) should not be taken by pregnant women for the prevention of migraine headaches.

The FDA said it based this new warning on a study which found that these medications can cause decreased IQ scores in children whose mothers consumed the drugs while pregnant.

The federal agency also said that it would work with the drugs’ manufacturers to add stronger label warnings. Depakote is manufactured by Abbott Laboratories.

In particular, the FDA said it would change valproate’s pregnancy category for migraine use to an “X.” This means that the risks pregnant women face by using this drug “clearly outweighs any possible benefit,” according to the FDA.

The FDA said that valproate products such as Depakote would remain in pregnancy category “D” (meaning the drug’s potential benefits may be acceptable despite its potential risks) for treating epilepsy and bipolar disorder.

“As a lawyer dedicated to protecting the rights of consumers, I am troubled by this new warning,” said Driscoll, whose firm has a record of taking on pharmaceutical companies in complex civil litigation.

“Of course, our firm expects that women who have used Depakote while pregnant are concerned as well. We believe it’s important for these women and their families to take steps right away to learn more about the FDA’s warning and their legal rights.”

Driscoll noted that the FDA also issued a statement in December 2009 to remind healthcare professionals about the increased risk of neural tube, craniofacial, cardiovascular and “other major birth defects” in babies exposed to Depakote and other valproate products during their mother’s pregnancy.

“When warnings come out about the side effects or complications associated with certain drugs, the question is always whether consumers received this warning on time – when harm could have been avoided,” Driscoll said. “We believe it’s important to contact an attorney who can look into those issues and help one to sort through their legal options.”

About The Driscoll Firm, P.C.

The Driscoll Firm, P.C., is dedicated to fighting for the rights of people and families injured by the wrongful acts of individuals and companies. The firm is currently investigating national injury claims involving product liability, defective drugs, dangerous medical devices, medical malpractice, car accidents, premises liability, spinal cord injuries, birth injuries, Cerebral Palsy, brain injuries, Erb's palsy and other circumstances that have caused serious injury or death. The Driscoll Firm, P.C., is based at 211 N. Broadway, 40th Floor, St. Louis, MO, 63102, and serves clients nationwide. To learn more, call (800) 305-9800 or use the firm’s online contact form. All initial consultations are free and confidential.

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