By Drew FitzGerald – DOW JONES NEWSWIRES | Friday March 4, 2011 12:45 PM EST
The U.S. Food and Drug Administration said it will strengthen warnings on the anti-migraine and anti-seizure treatment Topamax and its generic equivalents after new data suggested a higher risk for cleft palates in babies born to women taking the drug.
The move represents a setback for health-care products giant Johnson & Johnson (JNJ), which owns Topamax maker Ortho-McNeil Pharmaceutical LLC. The subsidiary last May pleaded guilty to promoting the drug for off-label uses and had to pay an $81.5 million fine.
The warning could also affect Vivus Inc. (VVUS), which is trying to get its weight-loss drug Qnexa to the market after the FDA asked for more information about its potential to cause birth defects. Qnexa is a combination of topiramate and the stimulant phentermine, which work together to reduce appetite and make the user feel more satisfied.
Shares of Vivus fell 7.8% to $6.50 Friday, while Johnson & Johnson shares were off 0.9% to $60.52 amid a broad market decline.
The FDA said Friday that data from the North American Antiepileptic Drug Pregnancy Registry indicated an higher risk of oral clefts in infants exposed to topiramate, the main ingredient in Topamax, during the first trimester of pregnancy. Infants exposed to topiramate as a single therapy had a 1.4% prevalence of oral clefts, compared with a 0.38% to 0.55% prevalence in those exposed to other antiepileptic drugs.
The regulator said health care professionals should warn patients of childbearing age about the drug ingredient’s hazard and said it will strengthen the warning on the drug’s labeling.
The new labeling will mean there is positive evidence of human fetal risk based on human data, but the potential benefits of the drug in pregnant women could sometimes outweigh the risks.
In a statement, Johnson & Johnson said it is working with the FDA to update the Topamax label and noted that the current prescription information already recommends cautious use in pregnant patients.
Topamax is used as an epilepsy treatment and as a preventative drug to prevent migraines before they start.
If you took Topamax (topiramate) or any other anti-seizure drug during pregnancy and your child was born with a cleft palate, cleft lip or any other congenital cranio-facial birth defect, we encourage you to contact a Topamax Birth Defects Lawsuit Attorney at our law firm immediately. It may be too late to recover from all of the devastating effects of Topamax but an experienced products liability pharmaceutical lawsuit lawyer at the Willis Law Firm can assist you in legal action against Johnson & Johnson (JNJ) and Ortho-McNeil Pharmaceutical LLC, the makers of Topamax. You are not alone. Join other birth defect victims and their families in speaking up and fighting for your legal rights.
Please fill out our free online legal evaluation form and we will contact you within 24 hours. Please keep in mind that certain states have statutes of limitation that limit the amount of time you have to file a lawsuit or seek legal action. Contact our law firm immediately so that we may explain the rights and options available to you and your family.