Only one month after Johnson & Johnson was required to put a black box warning on Regranex and a week after the U.S. Food and Drug Administration rejected a black box warning on epilepsy drugs, research has found that J&J's Topamax may increase the risk of birth defects.
The study, a small one of 203 patients, found a 14-fold increase in the risk of birth defects in patients taking the epilepsy drug Topamax. The risk was potentially even higher in patients that took Topamax with valproate (Depakote) or other epilepsy medications.
Due to the small size of the study, experts have stressed that more research is needed to confirm the possible birth defect link. Experts also stated that pregnant women who suffer from epilepsy should not stop taking there drug as the seizures without the medication can have an even greater damaging effect on the fetus. However patients taking the medication for the purpose of migraine relief and who are pregnant or contemplate getting pregnant are prompted to talk to the health care provider about a suitable alternative.
Epilepsy Drugs to get FDA Warning
Epilepsy Drugs Likely to Avoid FDA Black Box Warning
Alcoholics’ Quality of Life Improves with Topiramate
[Source:FiercePharma]
» Topamax Gets 6 Month Pediatric Exclusivity Extension from PharmaGazette
The U.S. Food and Drug Administration has granted a six month pediatric exclusivity to Ortho-McNeil-Janssen Pharmaceuticals for its drug Topamax for use in patients aged 1 to 24 months with partial onset seizures.The extension does not give the drug FD... [Read More]
Tracked on: August 2, 2008 5:56 PM | Permalink to Trackback