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Topamax Birth Defects

March, 2011 – The FDA issues a safety announcement to pregnant woman regarding the risk of fetal birth defects. Read FDA safety announcement here »

Federal drug regulators approved Topamax (and its generic equivalent, Topiramate) as an anti-epileptic drug and for prevention of migraines. On March 4, 2011, The FDA announced that Topamax would carry a pregnancy “Category D” warning which means that there is positive evidence of human fetal risk. Other Category D drugs include alcohol, lithium and most chemotherapy drugs to treat cancer. 

Prior to the recent FDA safety announcement, Topamax was classified as a Pregnancy “Category C” drug. Category C drugs are generally thought of as drugs that should be taken only if the benefit of taking them outweighs the risk. This category includes Sudafed, Cipro and some antidepressants. 

Data from pregnancy registries indicate that infants exposed to Topamax in utero have an increased risk of cleft lip and/or cleft palate. Oral clefts happen early in pregnancy, before many women even know they are pregnant. For this reason, women of childbearing age need to be extremely careful when taking Topamax.

Babies with cleft lips and/or palates have feeding difficulties, increased ear infections and the cleft palate often affects a child's speech, since the palate is necessary for speech formation.  Although surgery is often used to close the lip and palate, the child's speech pattern may still be affected despite surgical repair.

Children born to pregnant women who took Topamax may also have other birth defects including limb malformations and hypospadias (an anomaly in which the urethra opens on the ventral surace of the penis)

In 2008, Topamax was the highest selling epilepsy drug on the market, generating sales of $2.7 billion for Ortho-McNeil Pharmaceutical (a subsidiary of Johnson & Johnson) prior to losing its patent protection in 2009. Worldwide, more than 4 million patients have been treated with Topamax. Although approved only for treatment of epilepsy and migraines, Topamax has been prescribed for disorders other than epilepsy including such things as migraines, anger control, nightmares and weight loss.

Teva Pharmaceutical, Watson Pharmaceuticals, Mylan Inc., and other generic drug makers also sell the drug under its chemical name “Topiramate”. Generic versions of the drug pose exactly the same health risks to pregnant women

Currently, TorHoerman Law is pursuing cases of fetal injury including cleft lip and/or palate, spina bifida, Hypospadias, Epispadias, limb malformation and other birth defects.

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