New Birth Defect Warning for Topamax
FDA: Epilepsy Drug Raises Risk of Cleft Lip and Cleft Palate When Taken During Pregnancy
What is Topamax®?
Topiramate, or Topamax®, is approved by the FDA for treating seizures associated with epilepsy and to prevent migraines. But it is also sometimes used on an off-label basis to treat other conditions, such as obesity, bipolar disorder, and alcoholism.
Topamax® is manufactured by Ortho-McNeil Neurologics, a subsidiary of Johnson & Johnson. Generic Topamax® versions have been available since 2006.
Birth Defects/Side Effects
In March 2011, the FDA issued a warning that Topamax® side effects may increase the risk of oral cleft birth defects, such as cleft lip and cleft palate, among babies born to mothers who took the drug during the first trimester of pregnancy. As a result of inadequate warnings previously provided, many women were not aware they may be exposing their baby to a potential risk of Topamax® birth defects.
The FDA has urged doctors to avoid giving Topamax® to pregnant women or women who are of child-bearing age and at a high risk of pregnancy. Alternative epilepsy drugs may not carry the same risk for the unborn child.
In July 2008, a small study published in the medical journal Neurology identified a potential link between the use of Topamax® during pregnancy to an increased risk of serious birth defects. Children born to women who used Topamax® during pregnancy were found to develop a cleft lip or palate at a rate 11 times hirer than would be expected in the general population. The study also indicated that children exposed to Topamax® developed genital defects at a rate 14 times higher than would be expected.
The FDA required new warnings in 2011 after data from the North American Antiepileptic Drug Pregnancy Registry found that children born to mothers who took Topamax® during the first trimester of pregnancy experienced an oral cleft about 1.4% of the time, compared to a prevalence rate of between 0.33% and 0.55% associated with other epilepsy drugs.
Topamax Birth Defects
- Cleft Lip
- Cleft Palate
- Genital Malformations (Hypospadias)
- Other Topamax Birth Defects
If you or a loved one used Topamax® during pregnancy and had a child born with a Cleft Lip or Cleft Palate potentially associated with this drug use, please call Steinberg Law Firm P.C. at 888-529-4688 or email firstname.lastname@example.org for a free consultation.
Consult A Lawyer on Legal Issues
We encourage you to contact us at 888-529-4688 to discuss your Topamax® case with an experienced personal injury and wrongful death attorney.
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Consult A Doctor On Medical Issue
The Steinberg law firm does not intend, by this web site or otherwise, to dissuade anyone from taking medication without their doctors' approval. Please consult your doctor, not your lawyer, on matters relating to your health. It could be dangerous to stop taking medicines, especially abruptly. Patients should talk to their physicians to decide whether the benefits and risks of taking Topamax® make it the right choice for them.