Topamax Litigation
anticonvulsant medication linked to birth defects
Topamax (Topiramate) is an anticonvulsant medication that treats epileptic seizures, Lennox-Gastaut syndrome related seizures, and as a preventative medication for migraine headaches. The drug, however, has many off-label uses: bipolar disorder, obesity, alcoholism, post traumatic stress disorder, infantile spasm, cluster headaches, severe headaches, depression, autism.
What brought you here
Birth defects from the mother’s usage of Topamax during pregnancy.
The alert: FDA Label Change
You can view the FDA notice in its entirety here
March 4, 2011
FDA notified healthcare professionals and patients of an increased risk of development of cleft lip, cleft palate (oral clefts), heart defects, and other deformities in infants born to women treated with Topamax (topiramate) during pregnancy. Because of new human data that show an increased risk for birth defects, topiramate is being placed in Pregnancy Category D. Pregnancy Category D means there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women may be acceptable in certain situations despite its risks. The patient medication guide and prescribing information for Topamax and generic topiramate will be updated with the new information.
Who brought you here
Johnson & Johnson, parent company of Ortho-McNeil Neurologics, manufacturer of Topamax.
Birth defects your child may have
Cleft palate, cleft lip, heart defects, spina bifida, hypospadias, and other congenital malformations.
In the news
- Epilepsy drug Topamax risks birth defects
- Topamax May Raise Risk of Birth Defects
- FDA Warns of Birth Defects with Topamax
- Family Physicians Warned About Topamax Birth Defects
What this means for you
Protect yourself.
You potentially deserve, and may be entitled to, restitution for what has happened to your family. We would be more than happy to assist you in that effort. And though we know remuneration can only go so far, it makes a statement to others that you were wronged. Let us look into the details surrounding your particular situation. You may have a case. Please call us at your convenience toll-free at 1-800-218-4858.
About Our Law Firm
Clark, Burnett, Love & Lee is a nationally recognized law firm dedicated to helping victims of corporate negligence and malfeasance. Based in Houston, Texas, the firm represents clients from coast to coast with uncompromising integrity and aggressiveness.
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The Food and Drug Administration (FDA), an agency within the U.S. Department of Health and Human Services, is tasked with protecting the public health by assuring the public safety and effectiveness of human drugs, vaccines, other biological products, and medical devices, among others.
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