On March 4, the U.S. Food and Drug Administration announced new data that suggests that Topamax (topiramate), a medication used to treat certain types of seizures in individuals who have epilepsy, increases the risk that an infant will be born with the birth defects cleft palate and cleft lip when a mother takes the drug during their pregnancy.
Topamax is an antiepileptic medication the FDA approved to be used either alone or in addition to other medication to treat epilepsy. It has also been approved by the FDA to prevent migraine headaches, but not to ease migraine headache pain when they occur. Additionally, Topamax has been used by some for “off-label” or unapproved uses for other medical conditions, which the FDA says may not be regarded as serious.
According to the new data, a link between Topamax and oral clefts has been found. Babies who were born to mothers who took Topamax during their pregnancy had a significantly higher occurrence rate of oral clefts than babies born to mothers who took other antiepileptic medication or no medication whatsoever during their pregnancy.
Cleft palate and cleft lip, commonly referred to collectively as oral clefts, occur when parts of a fetus’ palate or lip do not fuse together properly during the early part of the first trimester of their mother’s pregnancy. This time is particularly dangerous as most women do not know they are pregnant during their first trimester, which makes the potential fetal risk of Topamax oral clefts all the more hazardous if a woman of childbearing age does not know they should consult a healthcare professional regarding the drug. Oral clefts are serious birth defects that have severe side effects, including difficulty eating, poor growth, speech problems, recurrent ear infections, and more.
How prevalent is Topamax usage? The FDA reports that about 32.3 million prescriptions for the drug and its generic forms were dispensed between January 2007 and December 2010, and roughly 4.3 million patients filled prescriptions for the drug from pharmacies in the United States. Due to its widespread use, many Topamax lawsuits are expected to be filed.
Do you need a Topamax lawyer? If your baby was born with an oral cleft and you were taking Topamax or another drug during the pregnancy, you may have a viable Topamax lawsuit. If a healthcare professional failed to adequately warn you of the risks of Topamax and did not inform you of alternative medications, the healthcare professional may be held legally responsible for your baby’s birth defect. To learn how the Topamax lawyers at Anapol Weiss can help you, call 866-735-2792 today.