Parker Waichman LLP

Study Fails to Clarify Topamax Birth Defect Risk

A new study has proven inconclusive on Topamax birth defects because of the small amount of Topamax patients involved in the fairly large study. The research, said WebMD, reviewed newer antiseizure medications taken by pregnant women during their first trimester. The large study, which will appear in the Journal of the American Medical Association, essentially […]

A new study has proven inconclusive on Topamax birth defects because of the small amount of Topamax patients involved in the fairly large study. The research, said WebMD, reviewed newer antiseizure medications taken by pregnant women during their first trimester.

The large study, which will appear in the Journal of the American Medical Association, essentially reviewed the antiseizure medication Lamictal (generic: lamotrigine), said WebMD. The study did reveal that a slightly increased risk in birth defects in expectant mothers versus other women who did not take antiseizure medications; however, only just a little over 100 women in the group of 800,000 women took Topamax (generic: topiramate), noted WebMD. The participants were part of the Danish registry study.

Researcher Anders Hviid, MSc, of Copenhagen’s Statens Serum Institut told WebMD that, “We cannot conclude anything or make any recommendations on , based on this study,” he said. Use of antiseizure drugs in pregnant women is on the rise because while about one in 200 women take the medication for epilepsy, the medications are being used to treat other conditions, including migraines and bipolar disorder, noted WebMD.

The study reviewed data on 837,795 live births occurring in Denmark from January 1996 through September 2008, including 1,532 women who took a so-called second-generation antiseizure medication in their first trimester. Over 1,000 took Lamictal; 400, Trileptal (generic: oxcarbazepine), 100, Topamax, and about 60 each, Neurontin (generic: gabapentin) or Keppra (generic: levetiracetam), said WebMD. Some of the participants did take more than one medication.

The study revealed major birth defects in 3.2 percent of infants exposed to one of the drugs in the fetus’ early development; 2.4 percent of babies were not exposed to antiseizure drugs, said WebMD. About 4.6 percent who took Topamax and 3.7-4 percent who took Lamictal gave birth to infants with major birth defects, said WebMD.

Earlier this year, the U.S. Food & Drug Administration (FDA) moved Topamax from Pregnancy Category C to Pregnancy Category D, after data indicated that women taking the drug in the early months of pregnancy face a higher risk of having a baby with an oral cleft. The Pregnancy Category D designation means that there is positive evidence of human fetal risk based on human data, but potential benefits in pregnant women may outweigh risks in certain situations.

According to the FDA, data from the North American Antiepileptic Drug (AED) Pregnancy Registry indicated that infants exposed to Topamax as a single therapy during the first trimester of pregnancy experienced a 1.4 percent prevalence of oral clefts, compared with a prevalence of 0.38–0.55 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.

Oral clefts are birth defects that occur when parts of the lip or palate do not completely fuse together early in the first trimester of pregnancy, a time when many women do not know they are pregnant. They can range from a small notch in the lip to a groove that runs into the roof of the mouth and nose, possibly leading to problems with eating, talking, and to ear infections.

Topamax may also be linked to other birth defects. According to the FDA’s Adverse Event Report database, there have been a total of 244 reports made to the agency of injuries to children believed to be associated with the use of Topamax. Of those, more than 100 involved possible Topamax birth defects, including 29 oral clefts, 29 limb malformations, 27 heart defects, 26 reports of other congenital defects, 23 cranio-facial defects, 15 reports of spina bifida/spinal malformations, and 5 reports of persistent pulmonary hypertension of the newborn (PPHN).

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Parker Waichman LLP helped my family with my father's 9/11 VCF Claim. My dad was in downtown Manhattan when 9/11 happened. Because of that he was diagnosed with COPD. Unfortunately, in early 2020 when COVID hit, he passed away. It was determined that his COPD from 9/11 was a contributing factor in his death. Working with Parker Waichman during such a difficult time was so helpful. Tina Morace was an absolute godsend in the process. Any questions I had, and there were many, were answered immediately. She always responded with a phone call and an email to follow so that I had everything in writing. I highly recommend their services to anyone who is in need.
Lisa Rooney
a month ago
5 Star Reviews 150
About 7 years ago, my sister was in a car accident and was very pleased with the way the firm handled her case. Unforuntately, I was in a car accident and she recommended that I call Parker Waichman. I could not be more happy with the way the case was handled and the outcome. The staff is also very friendly, which was refreshing.
Paul Schaeffer
11 years ago
5 Star Reviews 150
Parker watchman handled my case wonderfully. I was very happy with my settlement.
Paula JeanBaptiste
6 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038