Birth Defects Possibly Linked to Valproic Acid: What Parents Should Know
Birth Defects Possibly Linked to Valproic Acid: What Parents Should Know
The FDA released a MedWatch Safety Alert in December 2009 which notified health care professionals and patients about the possible increased risk of major birth defects in babies exposed to a key ingredient in Depakote, valproate sodium (a sodium salt of valproic acid) during pregnancy. The FDA alert included the following recommendation: "Women who are planning a pregnancy or who become pregnant while taking valproate should contact their health care professionals immediately." Drugs containing valproic acid compounds include brand names such as Depakote, Depakote ER, Depakene, Depacon, divalproex sodium, Depakote CP and Stavzor.
Valproic acid is a chemical compound found in various anticonvulsant medications such as Depakote. Physicians prescribe these drugs for people with seizure disorders, epilepsy, the manic phase of bipolar disorder and migraine headaches. Since its approval by the U.S. Food & Drug Administration (FDA) in 1967, valproic acid has proven to be effective in these patients.
However, once a prescription drug is approved, the FDA, independent laboratories and others continue to study its use and any side effects that patients may experience. Over time, additional studies have revealed a potential connection between the drugs taken by pregnant women that contain valproic acid and a number of serious birth defects including spina bifida, cleft palate, craniofacial defects, cardiovascular malformations and neural tube birth defects.
The American College of Obstetricians and Gynecologists (ACOG) states that three of every 100 babies in the United States are born with a major birth defect. Many of these birth defects can be treated and even cured, but collectively they are the leading cause of death during the first year of a baby's life.
In some cases, pregnant women must take drugs with valproic acid to treat their epilepsy. The FDA recommends that these women should consider enrolling in the North American Antiepileptic Drug Pregnancy Registry by calling 1-888-233-2334 or visiting www.aedpregnancyregistry.org. According to the Registry, there were approximately 16 reported cases of birth defects in newborns of 149 women studied with epilepsy. These women were taking approximately 1,000 mg of valproic acid-based medications such as Depakote per day during the first trimester of their pregnancies. Three of those 16 cases were neural tube defects.
One of the most common neural tube defects is spina bifida. The March of Dimes calculates that caring for a child with a birth defect from Depakote will cost $140,000 to $170,000 during his or her lifetime. Spina bifida's lifetime treatment for spina bifida from Depakote is even more expensive, costing almost $300,000. It is this financial and emotional burden of caring for a child with a major birth defect that has led many parents to turn to Depakote lawyers to seek compensation from the pharmaceutical companies for alleged valproic acid birth injuries. Recent court awards and out-of-court settlements have helped to reinforce the alleged link between valproic acid and severe birth defects. Valproic Acid injury lawyers and Depakote attorneys have the experience to guide distraught parents through a complex legal process and know the winning strategies to wield in the courtroom that can result in maximum compensation.
Parents, especially pregnant women, who have been taking an anticonvulsant medication such as Depakote containing valproic acid and have given birth to a child with a birth defect will learn even more by visiting www.depakotebirthinjury.com. There, they can register for a free and no-obligation claim review for a potential Depakote lawsuit. Throughout the process, parents' many questions will be answered and a qualified Depakote lawyer will outline the process for a possible Depakote lawsuit. Depakote lawyers found through the resources at DepakoteBirthInjuryc.om only receive a fee if the judgment is in the favor of the parents or plaintiffs.
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