The Consumer Justice Foundation Announces That Legal Help is Available to Parents of Children with Cleft Defects Who Took Topamax During Pregnancy

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Topamax birth defect claims are being investigated across the country as parents may be unknowingly exposing infants to the anticonvulsant drug in utero, possibly increasing the risk of major birth defects. Topamax is an anticonvulsant medication manufactured by Johnson & Johnson and approved by the FDA in 1996 to treat individuals suffering from epilepsy and migraine headaches. The Consumer Justice Foundation has developed to help parents that have given birth to children with birth defects and have taken anticonvulsants such as Topamax during pregnancy seek legal recourse.

Topamax and Birth Defects

Topamax and Birth Defects

Women who take Topamax during pregnancy may significantly increase their risk of giving birth to infants with one or more severe birth defects, including cleft injuries like cleft lip and cleft palate.

With the release of new studies concerning the alleged harmful nature of the anticonvulsant drug Topamax, potential birth defect victims are beginning to consult Topamax attorneys about the benefits of filing a Topamax lawsuit (Source: “The Teratogenicity of Anticonvulsant Drugs”, New England Journal of Medicine, April 2001). Women who take Topamax during pregnancy may significantly increase their risk of giving birth to infants with one or more severe birth defects, including cleft injuries like cleft lip and cleft palate. Children born with these craniofacial defects typically require reconstructive surgery in order to correct the defect and alleviate the complications associated with these birth defects. Unfortunately, the proper medical care for birth defect of this kind may result in costly medical expenses which can be an overwhelming burden for the families of birth defect victims.

Topamax was approved by the U.S. Food and Drug Administration in 1996 as a treatment for partial onset and primary generalized tonic-clonic seizures associated with epilepsy. In 2004, the FDA added an indication for the prevention of migraine headaches in adults. Topamax (topiramate) functions by slowing down certain impulses in the brain which cause seizures, and is used alone as monotherapy or in combination with other anticonvulsant medications to treat epilepsy.

In March 2011, the FDA elevated the pregnancy category of Topamax from C to D because of an increased risk of cleft lip and cleft palate in infants born to women who received Topamax treatment during pregnancy (Source: “Topamax Risk for Development of Oral Clefts”, March 2011, Category D indicates that there is positive human evidence of the medication's potential to cause serious harm to a fetus when taken during pregnancy. The FDA has also advised physicians to avoid prescribing Topamax to pregnant women unless the possible benefits of the treatment outweigh the potential risks to the fetus.

Children born with cleft lip and cleft palate typically struggle with multiple complications associated with the birth defects, including feeding difficulties, chronic ear infections, hearing loss, missing or malformed teeth, and speech and language delay. The only way to repair the cleft and restore the function and appearance of the malformed structure is for the child to undergo reconstructive surgery. In some cases, the child may even require multiple surgical procedures. After surgery, a child with an oral cleft may require long-term dental and orthodontic care in order to monitor the child's development and prevent additional complications. Unfortunately, long-term care can result in exorbitant medical bills which may present a devastating burden for the victim's family. By filing a Topamax lawsuit, victims of infant birth defects can seek financial compensation for their injuries and costly medical expenses, as well as the pain and suffering endured by the victim and his family.

With this newly elevated FDA Topamax pregnancy warning and the release of several birth defect studies, women who took Topamax during pregnancy and gave birth to an infant with one or more severe birth defects should consult a Topamax attorney to discuss their legal options. You may have grounds to file a Topamax lawsuit or form a potential Topamax class action lawsuit against Johnson & Johnson in order to protect your rights and collect the compensation you are entitled to. For more information regarding the side effects of Topamax, potential Topamax birth defects, and Topamax lawsuit information, visit


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