In studies Topamax caused birth defects, miscarriages, and low fetal weight when given to pregnant rabbits and mice. When Topamax was given to pregnant women, it also caused some oral cleft birth defects.
The Food & Drug Administration applies A, B, C, D, and X categories to different prescription drugs for pregnant women.
Some drugs approved by FDA that are safe and effective for use by non-pregnant women may pose added risks to pregnant women and their infants. The FDA assigns all approved drugs to a pregnancy category based on data obtained from animal studies, clinical studies, or experience.
Drugs in Pregnancy Category C are designated for medicines that have not been studied in pregnant humans but do appear to cause harm to the fetus in animal studies. Drugs in the Pregnancy Category D have human data presenting evidence of human fetal risk, but the potential benefits of these drugs may still be considered acceptable in certain situations.
Topamax and its generic, topiramate were in Pregnancy Category C when released in the pharmaceutical marketplace.
Anticonvulsants Causing Cleft Palate
Topamax is anticonvulsant drug. Anticonvulsants causing cleft palate and cleft lip birth defects are prescribed to women of childbearing age. Is this an ethical practice?
In March 2011, the FDA issued a press release announcing that the anticonvulsant drug Topamax had new data suggesting that the drug Topamax (topiramate) and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy.
A cleft lip is a birth defect where the upper lip is partially split. A cleft lip can cause the lip to be split all the way up to the nostrils on either or both sides of the lip. A cleft lip can be a standalone oral birth defect or combined with a cleft palate which does not close completely during pregnancy.
Data from the North American Antiepileptic Drug (AED) Pregnancy Registry indicate an increased risk of oral clefts in infants exposed to Topamax during the first trimester of pregnancy. Infants exposed to Topamax as a single therapy experienced a 1.4 percent prevalence of oral clefts, compared with a prevalence of 0.38 percent – 0.55 percent in infants exposed to other antiepileptic drugs.
Infants of mothers who did not have epilepsy and were not being treated with other antiepileptic drugs had a prevalence of 0.07 percent.
Before starting Topamax, pregnant women and women of childbearing potential should discuss other treatment options with their healthcare professional. Women taking Topamax should tell their healthcare professional immediately if they are planning to or become pregnant.
Anti Seizure Medications in Pregnancy: Topamax Dangers
For many women anti seizure medications are not optional – they are life saving.
Women who suffer from epilepsy or other seizure disorders depend on drugs such as Topamax to keep them from seizing. However, when those women become pregnant they have to weigh the benefits and dangers of taking anti seizure medications in pregnancy. Topamax, in particular, can be dangerous.
Topamax Cleft Palate
In March 2011, the FDA issued a warning telling women and their doctors that taking Topamax during pregnancy could increase children’s odds of being born with a cleft lip or palate. Topamax cleft palate injuries occur in about 1.4% of children born to mothers who took the drug during the first trimester of pregnancy. That is a higher percentage of children than children born to mothers taking other anti seizure medications and children born to mothers who are not taking any anti seizure medications.
The complications can be significant. Cleft lips and palates can lead to breathing, eating, and other significant issues for children.
Women who are pregnant (or who may become pregnant) and who are taking anti seizure medications are urged to speak with their doctors about the safest options for them and for their babies.
Why is Topamax Dangerous
You’ve heard the news. Topamax can be dangerous during pregnancy, but the question really is why. Why is Topamax dangerous for unborn children and should their mothers avoid it during pregnancy? What is the problem with Topamax?
According to the North American Antiepileptic Drug Pregnancy Registry, children born to mother who took Topamax while pregnant have an increased chance of cleft lip and/or cleft palate at birth. The risk is about two times greater when compared to women who did not take an anti-seizure medication and significantly higher than women taking other types of anti-seizure medication.
Thus, it may be dangerous to take Topamax. Pregnancy is a time when you want to give your child the very best start. Of course, at the same time you must take care of yourself. For that reason, it is important to discuss the dangers of Topamax with your physician and discuss whether other, safer, options exist to treat you and protect your baby.
Lawsuits Against Topamax
Lawsuits against Topamax are making headlines in the mainstream media. Trusting women who were prescribed Topamax for seizures, unknowingly took the drug only to find that Topamax causes birth defects when taken during the first trimester of pregnancy.
Monheit Law is seeking to represent women who want to file lawsuits against Topamax.
In March 2011, the U.S. Food & Drug Administration announced the problems associated with taking Topamax during the first trimester and oral birth defects like cleft palate and cleft lip.
Families with children who have birth defects are often overwhelmed with the day to day responsibilities of caring for their children, caring for other family members, and going to work. While lawsuits against Topamax make legal sense, people are often too distracted or too afraid to pursue.
At Monheit Law, we patiently explain what your legal options are. We only take your case if it’s the right fit and you want us to represent you. Monheit Law knows that your medical expenses are astronomical so we require no upfront or out-of-pocket expenses. If we file a lawsuit against Topamax, it’s on a contingency fee basis.You don’t pay for our services until your lawsuit against Topamax is won.