Depakote Side Effects

Depakote side effects may lead to birth defects when Depakote is used in pregnancy.  Contact a Depakote lawsuit attorney if you have been affected by Depakote side effects.

An emerging body of research suggests that Depakote side effects may be associated with a significantly increased risk of major birth defects among infants. Depakote remains one of the most frequently prescribed anticonvulsant drugs available in the U.S., even though several newer anticonvulsants have entered the market since Depakote was introduced in 1983. Although anticonvulsants like Depakote were initially developed as a treatment for epilepsy, the drugs have been approved for additional indications in recent years, and some are even prescribed by physicians for off-label uses. Since Depakote garnered FDA approval nearly thirty years ago, it has been approved to treat individuals suffering from epilepsy, seizures, migraine headaches and bipolar disorder. Depakote is made up of equal parts sodium valproate and valproic acid, which function by inhibiting the firing of certain impulses in the brain which cause seizures. Depakote is currently manufactured by pharmaceutical company, Abbott Laboratories.

As new studies are published concerning the adverse side effects of Depakote and other anticonvulsant drugs, the FDA and healthcare professionals across the country are taking steps to decrease the frequency of adverse outcomes among Depakote patients. According to the FDA and Depakote birth defect studies, infants whose mothers take Depakote while pregnant may be considerably more likely to develop serious birth defects like spina bifida and other nueral tube defects, compared to infants exposed to other anticonvulsants in utero and infants whose mothers received no anticonvulsant treatment while pregnant. In light of new information about potential Depakote side effects, the FDA advises all women of childbearing age to avoid taking Depakote unless it is considered essential for their treatment. Furthermore, women of childbearing age taking Depakote are urged by the FDA to use effective birth control, as other Depakote side effects have been shown to increase the risk of major birth defects when taken during pregnancy.

 

Alleged Depakote Side Effects of Birth Defects

In 2006, the FDA required Abbott Laboratories to include a "black box" warning on all Depakote prescriptions, alerting patients about instances of serious adverse side effects, including the potential for Depakote to interrupt fetal development and cause fetal malformations. In 2009, the FDA issued a safety announcement officially warning patients and healthcare professionals about the increased risk of major birth defects among infants exposed to Depakote during pregnancy. The FDA notice included neural tube birth defects like spina bifida, heart defects and craniofacial malformations like iniencephaly and cleft palate. Because of the potential for Depakote to cause serious fetal harm, the FDA has classified the drug as a pregnancy category D medication, the second highest category available when evaluating the pregnancy risks associated with pharmaceutical drugs. Category D is reserved for drugs which positive human evidence shows may cause serious harm to a fetus when taken during pregnancy. The birth defect side effects potentially associated with fetal exposure to Depakote include:

  • Neural tube birth defects
  • Heart defects
  • Cleft palate
  • Facial dysmorphism
  • Hand deformations
  • Fetal death
  • Fetal valproate syndrome
  • Spina bifida
  • Hydranencephaly
  • Growth retardation
  • Hypoplasia
  • Iniencephaly
  • Hypoplastic right heart syndrome
  • Skeletal defects

Once of the most revealing anticonvulsant birth defect side effects studies was published in the New England Journal of Medicine in 2001. Researchers involved in this study indicated that 20.6% of infants exposed to an anticonvulsant drug like Depakote developed major birth defects, compared to 28% of infants exposed to more than one anticonvulsant, and 8.5% of infants not exposed to any anticonvulsants in utero. Researchers concluded that anticonvulsant drugs are one of the most common causes of potential harm to a fetus in utero. According to data collected by the North American Antiepileptic Drug (NAAED) Pregnancy Registry and reviewed by the FDA, the rate of major malformations in babies born to women taking Depakote is almost four times higher than the rate among babies born to women taking other anticonvulsant drugs. The FDA reports that Depakote use in pregnancy increases an infant's risk of suffering from neural tube birth defects in particular. About 1 in 1,5000 infants in the U.S. is born with a neural tube birth defect; the risk is much higher among infants whose mothers took Depakote during early pregnancy: a shocking 1 in 20.

Depakote Use and Pregnancy Side Effects

According to the FDA, adequate folic acid consumption before and during pregnancy significantly reduces the risk of neural tube birth defects among infants. Unfortunately, studies have shown that anticonvulsant drugs side effects like Depakote can inhibit the body's ability to absorb folic acid, potentially leading to neural tube defects like spina bifida. In fact, FDA reports indicate that the rates for neural tube birth defects in babies exposed to Depakote during the first trimester are thirty to eighty times higher than the rate for neural tube defects in the general U.S. population. Furthermore, Depakote use by pregnant women with epilepsy is associated with a four-fold higher rate of major malformations such as facial malformations and skeletal defects overall, compared to other anticonvulsant drugs. If you are currently taking Depakote and you are pregnant or planning to become pregnant, consult your physician to discuss alternative treatment options.

Depakote Attorneys for Side Effect Lawsuits

Help is available for families of children born with major birth defects that may be due to Depakote side effects. As new studies are published regarding potential Depakote side effects, Depakote attorneys across the country are investigating Depakote birth defect claims. In fact, several Depakote class action lawsuits have already been filed by Depakote lawyers against Abbott Laboratories, on behalf of dozens of parents across the country who claim that Depakote side effects caused their children to be born with major birth defects. If you or a loved one has suffered from a birth defect and you believe Depakote to be the cause, contact a Depakote attorney to discuss the benefits of filing a Depakote lawsuit against Abbott. With the help of a Depakote attorney, victims of potential Depakote birth defects can collect financial compensation for their injuries, medical expenses, and pain and suffering. Pending Depakote class action lawsuits allege that Abbott was aware of the pregnancy risks associated with Depakote and failed to adequately warn consumers of these hazards. Too often, consumers are taken advantage of by big drug companies. With the help of an experienced Depakote lawyer, injured victims can protect their rights and collect the compensation they deserve.






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