Topamax FDA Warning
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The U.S. Food and Drug Administration (FDA) notified healthcare providers and patients about an increased risk of birth defects in babies whose mothers’ take Topamax® (topiramate) while pregnant. The FDA Topamax® warning was issued March 4, 2011.
If your baby is born with a birth defects, such as cleft lip/palate, contact a Topamax® birth defect lawyer for an evaluation of your case.
FDA Approval and Topamax®
The FDA approved Topamax® (topiramate), an antiepileptic medication, in January 1997, to reduce the occurrence of seizures, especially for patients in whom other antiepileptic medications do not work. The drug also is approved for use in combination with other antiepileptic drugs for seizures known as partial onset seizures. These are the most common type of seizure experienced by adults.
In addition, Topamax® is approved for the prevention of migraine headaches. The medication does not work once a headache has begun.
The drug was studied in over 2,000 epilepsy patients from around the world.
- Five clinical trials consistently showed the medication reduced the frequency of seizures.
- One trial showed patients’ frequency of seizures were reduced by at least half in 44 percent of patients and by at least 75 percent in 22 percent of patients.
Warning Issued by the FDA for Topamax®
On March 4, 2011, fourteen years after Topamax’s® approval, the FDA released a warning saying new data on the drug showed it could cause birth defects. The admonition said Topamax® could result in cleft lip and cleft palate in babies born to mothers taking the medication early in the first trimester of pregnancy.
In normal fetal development, both the lips and palate are separated into right and left sections until they fuse at a midline when the fetus is between six and 11 weeks old. If something interferes with the fetus’ development during this period, it can result in the failure of the lips and palate to fuse, leaving a cleft in their formation.
The FDA also announced it was adding a warning about the dangers of Topamax® to the medication’s label and changing the pregnancy category from Pregnancy Category C to Pregnancy Category D. This change means that the drug was found to cause birth defects in humans.
“Health care professionals should carefully consider the benefits and risks of topiramate (Topamax®) when prescribing it to women of childbearing age,” said Dr. Russell Katz, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Alternative medications that have a lower risk of birth defects should be considered,” he said.
Contact a Topamax® Birth Defect Lawyer
A qualified birth defect lawyer can help you and your baby seek justice from the makers of Topamax®. Contact a Topamax® cleft lip/palate lawyer to find out if you qualify for compensation.
