FDA Asks Healthcare Professionals to Weigh the Benefits and Risks of Topamax, Reports The CJF

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The FDA recently released a safety announcement urging healthcare professionals to consider all benefits and risks involved in Topamax treatment before prescribing the antiepileptic drug to women of childbearing age. According to the FDA, Topamax use during pregnancy may be linked to an increased risk of birth defects among exposed infants, particularly cleft lip and cleft palate. For more information about Topamax FDA warnings and the pregnancy risks of the antiepileptic Topamax, visit http://www.topamaxbirthinjury.com, a free online resource provided by the Consumer Justice Foundation (CJF) to help connect injured consumers with professionals who can help.

In light of new data concerning the potential link between Topamax use in pregnancy and the development of major birth defects (fda.gov/Drugs/DrugSafety/ucm245085.htm), the FDA has elevated the pregnancy category of the antiepileptic drug from C to D, meaning there is positive human evidence of the drug's potential to cause fetal malformations. This FDA action was largely influenced by new information collected by the North American Antiepileptic Drug (NAAED) Pregnancy Registry, which identified fetal exposure to topiramate (Topamax) as a risk factor for the development of oral cleft birth defects like cleft lip and cleft palate (Comparative Safety of Topiramate During Pregnancy, NAAED Pregnancy Registry). Upon review of this new Topamax birth defect information (fda.gov/Drugs/DrugSafety/ucm245085.htm), the FDA has asked healthcare professional to carefully weigh the benefits and risks associated with Topamax before prescribing the drug to women of childbearing age, especially for conditions not typically associated with permanent injury or death.

Topamax belongs to a class of prescription medications called antiepileptics, which were initially designed as a first-line of defense against epilepsy, and Topamax (topiramate) was approved by the FDA in 1996 for this purpose. In 2004, the FDA added an indication for Topamax in preventing migraine headaches, and the drug has since become one of the most popular methods of migraine prevention in the United States. Topamax is currently manufactured by Ortho-McNeil Pharmaceutical, a subsidiary of Johnson & Johnson.

According to the data collected by the NAAED Pregnancy Registry, the prevalence of oral cleft birth defects among infants exposed to topiramate (Topamax) during the first trimester of pregnancy was 1.4%, a twenty-fold increased risk compared to the prevalence of oral clefts among infants whose mothers received no antiepileptic treatment while pregnant (Comparative Safety of Topiramate During Pregnancy). A previous topiramate (Topamax) birth defect study published in the journal Neurology in 2008 indicated that infants born to women who took topiramate (Topamax) during pregnancy were eleven times more likely to develop oral cleft birth defects and fourteen times more likely to develop genital birth defects like hypospadias, compared to the expected rate among the general population (Topiramate in pregnancy: Preliminary experience from the UK Epilepsy and Pregnancy Register, ncbi.nlm.nih.gov).

Amid growing concerns about the safety of Topamax in treating pregnant women, the FDA has suggested that alternative medications associated with a lower risk of birth defects be considered for all women of childbearing age (fda.gov/Drugs/DrugSafety/ucm245085.htm). In addition, the FDA urges that, should the decision be made to use Topamax in women of childbearing age, effective birth control be used. Because oral cleft birth defects like cleft lip and cleft palate occur during the first trimester of pregnancy, before many women are aware they are pregnant, all women of childbearing age taking Topamax may be at risk of unknowingly causing serious harm to their unborn child (fda.gov/Drugs/DrugSafety/ucm245085.htm).

Cleft lip and cleft palate are craniofacial malformations characterized by the incomplete closure of a child's upper lip or palate, respectively, during the early stages of fetal development. Birth defects like cleft lip and cleft palate can cause serious side effects for an affected child, including feeding difficulties, dental problems, chronic ear infections, hearing loss, and even speech and language delays. Women who took Topamax during pregnancy and subsequently gave birth to a baby with one or more major birth defects should contact a Topamax attorney to discuss their legal options. The Consumer Justice Foundation offers injured consumers a comprehensive online resource through http://www.topamaxbirthinjury.com, which provides critical information about potential Topamax birth defects and experienced attorneys who can help victims collect the financial compensation they are entitled to.


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Faith Anderson
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