Johnson & Johnson’s Topamax, an epilepsy and migraine medication made by J&J subsidiary Ortho McNeil Pharmaceuticals, has been linked to a significantly increased risk of birth defects. According to the U.S. Food & Drug Administration (FDA), women who take Topamax – or its generic form topiragen – during pregnancy are 20 times more likely to have children with defects such as cleft lips and cleft palate (oral cleft) deformities.
The FDA issued a warning letter in 2011 to Topamax (topiramate) and topiragen users – along with healthcare professionals such as neurologists and OB/GYNs – that women who use these drugs during pregnancy are 20 percent more likely to give birth to a child with a cleft lip or cleft palate. This warning was based on information the FDA received from the North American and European pregnancy registries showing an increase in these injuries.
Cleft lips and cleft palates occur when a baby’s mouth doesn’t fully form. This can cause a “split lip” or a hole in the roof of the mouth which can become a serious condition as the infants may not be able get adequate nutrition. Cleft lips and palates can often be corrected, but doing so may require several painful and costly surgeries.
Topamax Birth Defect Lawsuits
Topamax, which generates billions of dollars in sales for Johnson & Johnson every year, is now included in the FDA’s Pregnancy Category D – which means that there is “ positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans.” If your child was born with a cleft lip or cleft palate birth defect after taking Topamax during your pregnancy, you may be entitled to compensation including medical and surgical bills, lost income, pain and suffering and more.