Topamax side effects may be associated with an increased risk of major birth defects, according to recent studies. Topamax has been available to American consumers since 1996, when the FDA approved the drug for the treatment of partial onset and generalized tonic-clonic seizures associated with epilepsy. In 2004, the FDA added an indication for Topamax in reducing the frequency and intensity of migraine headaches. Since this time, Topamax has become an increasingly popular treatment for the prevention of migraine headaches, a condition which affects more women of childbearing age than any other population in the United States. The active ingredient in Topamax is topiramate, and the drug works by interrupting the firing of certain impulses in the brain which cause seizure-related episodes. The pharmaceutical company responsible for manufacturing Topamax is Ortho-McNeil Pharmaceutical, which is actually a division of well-known drug company, Johnson & Johnson.
As new research focuses on the dangerous side effects of anticonvulsant drugs like Topamax, serious concerns about the safety of these drugs have been raised by physicians and patients around the country. Topamax side effects in particular may be associated with significant injury, primarily serious birth defects found in infants exposed to the drug during pregnancy. Unfortunately, pregnant women in the U.S. and other countries continue to take Topamax, either because they are unaware of the potential dangers linked to Topamax side effects, or because they think their treatment options are limited to Topamax alone. On the contrary, the FDA has advised patients and physicians to consider alternative medications to Topamax that have a lower risk of birth defect side effects, especially for treating conditions not typically associated with permanent injury or death.
Potential Topamax Side Effects of Birth Defects
Among the birth defects allegedly associated with Topamax side effects are oral cleft birth defects like cleft lip and cleft palate, and genital birth defects like hypospadias. According to data collected by the North American Antiepileptic Drug (NAAED) Pregnancy Registry, there is an increased risk of oral clefts among infants whose mothers take Topamax during pregnancy. The registry report indicated a 1.4% prevalence of cleft lip and cleft palate birth defects among infants exposed to Topamax in utero, which is more than twice the 0.38-0.55% prevalence among infants exposed to other anticonvulsant drugs. The prevalence of oral clefts among infants whose mothers received no anticonvulsant treatment while pregnant was 0.07%. In response to these findings, the FDA issued a safety announcement on March 4, 2011 warning patients and healthcare professionals about the increased risk of oral cleft birth defects among infants born to women who take Topamax while pregnant. The FDA also increased the pregnancy category of Topamax from C to D, which means there is positive human evidence of the drug’s ability to cause serious harm to a fetus exposed to the drug during pregnancy.
Previously, a study was published in the journal Neurology (2008) in which researchers suggested in-utero Topamax side effect exposure may be a risk factor for the development of cleft palate, cleft lip and hypospadias among infants. According to the results of this study, infants whose mothers took Topamax while pregnant were an alarming fourteen times more likely to be born with hypospadias, and eleven times more likely to be born with cleft lip or cleft palate, compared to the expected rate among the general population. According to researchers, the birth defect rate was even higher among infants whose mothers took Topamax in combination with Depakote (valproic acid), another popular anticonvulsant drug.
Cleft Lip, Cleft Palate and Hypospadias Side Effects
Alleged Topamax side effects of cleft lip and cleft palate are both craniofacial malformations affecting the long-term complications for an affected child, including feeding difficulties, dental problems, chronic ear infections, hearing loss, and delays in speech and language development. Hypospadias is a genital birth defect in which a male infant’s genitals form incorrectly in utero, causing the opening of the urethra to be located on the underside of the penis, rather than at the end. Children born with hypospadias typically suffer from problems during urination, a malformed foreskin, and complications like difficulty during toilet training in infancy and sexual intercourse in adulthood.
Side Effects of Topamax Use During Pregnancy
In light of new Topamax side effect information, the FDA urges healthcare providers to consider all benefits and risks associated with Topamax use before prescribing the drug to women of childbearing age. Furthermore, if the decision is made to prescribe Topamax to women of childbearing age, effective birth control should be used, as this drug may be linked to serious birth defect side effects like cleft palate, hypospadias, and cleft lip. With the FDA’s new classification of Topamax as a category D medication, the FDA has advised physicians to avoid prescribing the drug to pregnant women unless the possible benefits of the drug justify the potential risks to the fetus.
Topamax Side Effects Legal Help
For families of children suffering from birth defects potentially associated with Topamax side effects, a Topamax attorney can provide the legal help they need. Following a birth defect diagnosis, it may be difficult for families to concentrate on filing a Topamax lawsuit while also focusing on seeking medical care for their injured child. If you or a loved one is struggling with a birth defect which you believe to be linked to Topamax side effects, contact a Topamax lawyer to discuss your legal options. By filing a Topamax lawsuit against Ortho-McNeil Pharmaceutical (Johnson & Johnson), you can seek financial compensation for your injuries and medical expenses, as well as the pain and suffering endured by you and their family. Victims of alleged Topamax birth defect side effectss are not at fault and should not be held accountable for the long-term consequences commonly associated with a birth defect. With the help of a Topamax lawyer, you can protect your rights and collect the compensation you deserve.