Category: Side Effect: Birth Defects (abnormality, congenital malformation)
-
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,…
-
European Medicines Agency (EMA) Committee Recommends Further Restrictions On Use Of Depakote / Depakene / Depacon By Women Of Childbearing Age
Cites Higher Risks Of Neural Tube Defects Like Spina Bifida, Hypospadias, And Other Birth Defects As Well As Increased Risk Of Autism Spectrum Disorder (Posted by Tom Lamb at DrugInjuryWatch.com)More restrictions of the use of valproate drugs…
-
Significantly Increased Risk Of Autism Spectrum Disorder (ASD) In Children Whose Mothers Used Depacon / Depakene / Depakote During Their Pregnancy
August 2014 Label Change By AbbVie Inc. (formerly Abbott) For These Valproate Migraine, Epilepsy/Seizure, And Bipolar Medications Was Done Rather Quietly (Posted by Tom Lamb at DrugInjuryWatch.com)Without much notice, e.g., no FDA Drug Safety Communication was issued,…
-
Antidepressant-Related Birth Defect: Heart And Lung Disorder PPHN – Persistent Pulmonary Hypertension Of The Newborn
Increased Risk Of PPHN When Women Use SSRIs Medications Like Celexa, Lexapro, Paxil, Prozac, And Zoloft After Their 20th Week Of Pregnancy (Posted by Tom Lamb at DrugInjuryWatch.com) A recent medical journal article, "Prenatal…
-
Depacon / Depakene / Depakote: 400% Increased Risk Of Birth Defects Compared To Other Anti-Seizure Medications Used By Mothers With Epilepsy
May 2013 Revised Depakote Drug Label Includes "Black-Box" And Warnings About These Congenital Malformations As Well As Decreased IQ Scores In Children (Posted by Tom Lamb at DrugInjuryWatch.com) As indicated below, in May 2013…
-
Depakote Or Depakene Taken During Pregnancy May Cause Congenital Malformations Or Birth Defects Such As Neural Tube Defects Like Spina Bifida
In Addition, There Are FDA Warnings That Using Depakote Or Depakene While Pregnant May Put Child At Risk For Having A Lower IQ Score Later In Life (Posted by Tom Lamb at DrugInjuryWatch.com) Depakote…
-
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…
-
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…
-
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…