The anticonvulsant topiramate is sold under the brand name Topamax. Researchers are currently trying to determine whether Topamax has caused disfiguring birth defects in babies born to mothers who were taking the drug while pregnant.
You shouldn’t have to go through more trouble to be compensated for the harm you’ve already suffered. The Rottenstein Law Group, a Topamax law firm, knows this, and we want you to believe it. You need a sympathetic advocate who will represent only your interests—and who will make the process as painless as possible. If you’ve taken Topamax and you or your baby has been harmed, contact RLG for a free consultation immediately.
What Is Topamax, and What Is It Prescribed For?
Topamax is a brand name for topiramate. Discovered and first produced by Johnson & Johnson divisions Ortho-McNeill and Noramco, Inc., this prescription medication is used to treat epilepsy in children and adults. It can also be used for Lennox-Gastaut syndrome, migraine headaches, and bipolar disorder, and to prevent weight gain for those on anti-depressants. Researchers are also testing the drug as a treatment for alcoholism, obesity, binge eating, and PTSD. It has numerous off-label uses as well. The U.S. Food and Drug Administration (FDA) first approved Topamax in 1996, and it is now available in generic form.
Administered in 25 mg to 200mg oral doses, the body only absorbs about 30 percent of the topiramate present. Scientists are unsure how the drug works once in the body, though. Theories revolve around altering the function of neurochemical transmitters.
In May, 2010, Ortho-McNeill pled guilty for claiming—without any study or trials as evidence—that Topamax could treat psychiatric disorders that it wasn’t approved to treat. The FDA fined the company $6.14 million. From 2007 to late 2010, 4.3 million people filled 32.3 million Topamax prescriptions.
Topamax Side Effects
Recent controversies have rocked consumer confidence in Topamax. In late 2008, the FDA issued a Topamax warning regarding the epilepsy drug’s tendency to cause its users to commit suicide. However, there has been no Topamax recall yet, and the Rottenstein Law Group does not know of any recent Topamax lawsuits or Topamax class action lawsuits.
In January 2008, the FDA began providing doctors a review of two hundred medical studies (involving 44,000 different people) that indicated that Topamax caused an increase in suicidal ideations and behaviors in users. Consequently, the FDA required placement of a suicide warning on Topamax’s label.
More recently, the drug has been found to cause birth defects when pregnant women use the drug. In July 22, 2008, an article in Neurology magazine described a study of 203 pregnant Topamax users conducted out of Belfast, Northern Ireland. Of 178 births the study described, sixteen had major birth defects, which is a rate of eleven times over the average. Four of the sixteen children were born with cleft lips or palates. This is a condition in which the cartilage above the lip fails to develop properly, leaving a disfigured face. Often this can be corrected with surgery, but it can still result in ear disease, speech problems, and problems in early socialization. Four of the male babies were born with genital defects; specifically, two had hypospadias, a defect in which the urethra does not locate at the tip of the penis. When it was first approved, the FDA gave topiramate a category C classification, meaning the drug was not tested on humans even though it was known to cause birth defects in animals.
On March 4, 2011, the FDA announced that a more substantial study than the Neurology one demonstrated a link between Topamax and birth defects. The data, from the North American Antiepileptic Drug (NAAED) Pregnancy Registry found cleft lips and palates occurred in children at a rate of 1.4 percent, whereas the rate is 0.38 to 0.55 percent for other anticonvulsants and the natural occurrence is .07 percent. The UK Epilepsy and Pregnancy Register reported similar results. The FDA recommends that women using Topamax use effective birth control and consult their physicians if they become pregnant.
RLG’s Topamax Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The Topamax lawyers at the Rottenstein Law Group believe that getting satisfaction from the company that harmed you shouldn’t be just more hardship. That’s why we do everything we can to streamline the process.
If you have taken Topamax and your baby suffered birth defects, contact RLG today.