Tag: topiramate
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Topamax Taken During Pregnancy Associated With A Significant Increased Risk Of Cleft Lip For Infants Born To Those Mothers
Recently Revised Topamax Label Includes Data Of 2014 Annual Report From The North American Antiepileptic Drug (NAAED) Pregnancy Registry (Posted by Tom Lamb at DrugInjuryWatch.com) By means of an October 21, 2014 FDA letter to Janssen Pharmaceuticals,…
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New Obesity Drug Qsymia / Qsiva Gets Gets Negative Opinion By European Medicines Agency (EMA)
Combination Pill Of Topamax And Phentremine Was Approved By FDA, But EMA Points To Heart Side Effects, Birth Defects, And Other Safety Issues (Posted by Tom Lamb at DrugInjuryWatch.com) On October 18, 2012 European drug regulators…
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Topamax During Pregnancy Increases Risk Of Cleft Lip And/Or Cleft Palate Birth Defects
Oral Clefts In Babies Are 20 Times More Likely With Women Who Used Topamax (topiramate) After Getting Pregnant (Posted by Tom Lamb at DrugInjuryWatch.com) In early March 2011 the FDA announced that the prescribing information…
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FDA Seeks Information About Topamax-Related Oral Cleft Birth Defect Cases
Request For Historical Incidence Data Made In Connection With NDA For New Obesity Drug (Posted by Tom Lamb at DrugInjuryWatch.com)In mid-January 2011 the biopharmaceutical company Vivus, Inc. — while providing a regulatory update on…