After years of controversy over the safety of anti-convulsant/migraine-prevention drug Topamax, a recent study in human test subjects showed that Topamax greatly increases the risk of cleft lip and cleft palate birth defects.
The new data has prompted the FDA to alert doctors to Topamax’s birth defect danger and to require a strong warning of this danger in Topamax (generic name: topiramate) labeling and prescribing information.
In reaction to the evidence of the birth defects in human tests, the FDA has also moved Topamax into Pregnancy Category D — a rating that tells doctors to carefully weight the risks and benefits of the drug before prescribing it to treat epilepsy seizures or migraines, because there is positive evidence of human fetal risk.
An FDA doctor addressed the risk/benefit analysis in the March 4 FDA press release on the newly reveled dangers of Topamax.
“Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age,” said Russell Katz, M.D., 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.”
Even though studies conducted with animals had long shown that Topamax significantly increases the risk of such birth defects, the FDA had kept the drug in Pregnancy Category C, which is intended to indicate to doctors that “potential benefits may warrant use of the drug in pregnant women despite potential risks.” That category has now been shown to be inadequate to warn women, and their doctors, of the dangers of Topamax use, particularly in light of other, less dangerous seizure and migraine drugs.
The latest study showed the birth defect risk of Topamax is more than three times as high as that seen with other seizure medications, leading some doctors to question whether Topamax should ever be prescribed for women who could become pregnant.
Lawyers at the Pensacola-based law firm of Aylstock, Witkin, Kreis & Overholtz are investigating the extent of the Topamax risks and appropriate legal actions. For more information about drugs known to increase the risk of birth defects, see www.drugsandbirthdefects.com.
- FDA MedWatch Safety Information
http://www.fda.gov/Safety/MedWatch/…/ucm245777.htm - FDA Press Release: Risk of oral birth defects in children born to mothers taking topiramate
http://www.fda.gov/NewsEvents/….htm - FDA Questions and Answers: risk of oral clefts in infants born to mothers taking Topamax
http://www.fda.gov/Drugs/DrugSafety/ucm245470.htm - FDA Drug Safety Communication
http://www.fda.gov/Drugs/DrugSafety/ucm245085.htm - FDA Pregnancy Categories explained
http://en.wikipedia.org/wiki/Pregnancy_category - New York Times article: Women Warned About Epilepsy Drug
http://www.nytimes.com/2011/03/05/us/…twrhp