As of yet, the anti-seizure drug Topamax has not been recalled as a whole by the Food and Drug Administration (FDA). In order for there to be a large-scale Topamax recall, there would have to be significant evidence showing that Topamax poses a serious health risk to a majority of its users. At this time, this is not the case for Topamax, although there has been scientific evidence suggesting that a significant portion of patients are at a higher than normal risk of having children with certain birth defects if taking Topamax during pregnancy.
There was, however, a recall of approximately 57,000 bottles of Topamax due to reports of bad odors coming from the medication. This Topamax recall occurred in April of 2011. The Topamax recall was of 57,000 bottles of Topamax 100mg tablets. It was reported that the Topamax recall likely occurred because of some wood preservative getting into the Topamax bottles. Traces of chemical byproduct TBA (2, 4, 6 tribromarnisole) were found in the containers which is a commonly used wood preservative in shipping palates.
While there hasn’t been a full Topamax recall yet, recent data and actions by the Food and Drug Administration have suggested that there may be some risks to taking Topamax while pregnant. Topamax was recently changed from being a pregnancy category C drug to a pregnancy category D drug by the Food and Drug Administration (FDA). Topamax had previously been a pregnancy category C drug for the 15 years since its introduction.
A pregnancy category C drug means that the drug might have some potentially dangerous side effects, but there has only been evidence of the side effects during animal trials. Pregnancy category D drugs have shown significant scientific data in human studies that the drug (Topamax in this case) may cause damage to an unborn human fetus.
A recent study, referenced in the Food and Drug Administration’s (FDA) warning stated that approximately 1.4% of infants born to mothers taking Topamax while pregnant develop an oral cleft defect such as cleft lip or cleft palate. This is compared with approximately .4% of infants born to mothers taking other epilepsy medications and only .07% of infants born to mothers not taking any anti-seizure medication.
Many new parents ask themselves what was the cause of my child’s birth defects? Did it happen during pregnancy? The antidepressant Topamax may be linked to causing the development of birth defects in unborn babies, infants, and children when their mothers took antidepressants while pregnant.
Our law firm is handling individual birth defect lawsuits against drug and pharmaceutical companies and currently accepting new Topamax cases across the nation. If your child was born with a birth injury that you believe may have been caused by taking an antidepressant like Topamax during pregnancy, then you should contact our law firm as soon as possible for a free confidential review of your potential birth defect lawsuit case. All cases are handled on a Contingency Fee Basis (no attorney’s fees or expenses charged unless we recover for you).