(OPENPRESS) July 14, 2011 -- New studies indicate that the migraine medicine Topamax may lead to the development of major birth defects when taken during pregnancy (Comparative Safety of Topiramate During Pregnancy NAAED Pregnancy Registry). The most revealing Topamax birth defect information, collected by the North American Antiepileptic Drug (NAAED) Pregnancy Registry and reviewed by the FDA, indicates that infants exposed to Topamax during pregnancy may be twenty times more likely to develop birth defects like cleft lip and cleft palate, compared to unexposed infants (fda.gov). In response to this information, the FDA has elevated the pregnancy category of Topamax from C to D, meaning there is positive human evidence of the drug's ability to cause serious harm to a fetus when taken during pregnancy (fda.gov).
Topamax is a prescription antiepileptic medication manufactured by Ortho-McNeil Pharmaceutical, a subsidiary of Johnson & Johnson. Topamax (topiramate) was approved by the FDA in 1996 for the treatment of epilepsy, and the FDA added an indication for the prevention of migraine headaches in 2004. Although Topamax cannot treat a migraine once it occurs, the medication is often used to reduce the frequency and intensity of these debilitating headaches.
In light of new information about Topamax pregnancy risks, the FDA has advised physicians to avoid prescribing Topamax to women of childbearing age, especially for conditions not typically associated with permanent injury or death (fda.gov). Although migraine headaches are debilitating for the mother, the condition poses little risk to the fetus and may not warrant the use of a potentially dangerous drug like Topamax. According to the FDA, alternative medications that have a lower risk of birth defects should be considered for women of childbearing age (fda.gov). If the decision is made to use Topamax in women of childbearing age, the FDA encourages these patients to use effective birth control to prevent unplanned pregnancies (fda.gov).
Although the FDA only recently increased the pregnancy category of Topamax, the potentially harmful nature of the antiepileptic drug has been evident for several years. In 2008, the journal Neurology published a study in which researchers sought to examine the adverse effects of fetal exposure to Topamax (Topiramate in pregnancy: Preliminary experience from the UK Epilepsy and Pregnancy Register). According to researchers involved in this study, infants born to women who took Topamax while pregnant were eleven times more likely to develop cleft lip or cleft palate, and fourteen times more likely to develop genital defects like hypospadias, compared to the expected birth defect rates among the general population (Topiramate in pregnancy: Preliminary experience from the UK Epilepsy and Pregnancy Register).
After reviewing new Topamax birth defect data, Topamax attorneys nationwide are reviewing Topamax birth defect claims filed by parents who believe their children have been affected by the antiepileptic drug. Women who took Topamax during pregnancy for migraine prevention and subsequently gave birth to a child with one or more birth defects should contact a Topamax attorney for legal help. Children who have been adversely affected by Topamax exposure may be entitled to lifetime medical care, which can be acquired by filing a Topamax lawsuit against Ortho-McNeil Pharmaceutical (Johnson & Johnson). The Consumer Justice Foundation offers American consumers more information about the migraine medicine Topamax and potential Topamax birth defects through www.topamaxbirthinjury.com, a comprehensive online resource connecting injured consumers to legal professionals who can help them collect the financial compensation they are entitled to.
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