Dangerous Topamax side effects have become the subject of potential lawsuits. Topamax has been linked to birth defects in children after unsuspecting mothers took the drug thinking it was safe.
New studies indicate that taking Topamax (topiramate) during pregnancy increases the risk of cleft lip, cleft palate and/or genital birth defects in newborns. Further warnings indicate that Topamax can also be harmful to breastfeeding newborns. In 2011, the FDA issued a warning to mothers about the dangerous birth defects this drug can cause in newborns. Topamax lawsuits have been filed against the drug’s manufacturer Ortho MacNeil-Janssen Pharmaceuticals, Inc., and it’s parent company Johnson & Johnson.
Topamax Symptoms Related to Birth Defects
In 2012, North American Antiepileptic Drug (NAAED) Pregnancy Registry published a study following 5,667 pregnant women from 1997 to 2011 who took anticonvulsants like Topamax and the resulting risk of infant malformations. The data found an increase of adverse pregnancy outcomes, including birth defects and low birth weight, linked to Topamax. Researchers concluded that exposure to topiramate resulted in a 10-fold increased risk of cleft lip compared to that of the reference population.
The Antiepileptic Drug Pregnancy Registry reports a 3.8 percent prevalence of oral birth defects in children exposed to Topamax in utero during the first trimester.
Two of the particular risks listed by this registry are cleft lip and/or cleft palate in newborns, which is known to develop in the first trimester of pregnancy before many women even know that they are pregnant.
Common congenital defects related to first-trimester exposure to Topmax include the following:
- Cleft lip (cheiloschisis) – Symptoms of cleft lip present as a small gap at the top of the lip or an indentation of the lip. Cleft lip can also continue into one nostril (unilateral complete) or both (bilateral complete).
- Cleft palate (palatoschisis) – A condition where the roof of the mouth (soft and hard palate) is not fully formed. A complete cleft palate can affect the soft and hard areas from uvula to the nasal cavity, and many times includes a cleft lip. It may also be limited to a hole in the roof of the mouth, which is referred to as an incomplete cleft palate.
- Hypospadias – Usually a male birth defect wherein the urethral opening appears on the underside shaft of the penis rather than the tip.
Topamax and Breastfeeding
It has also been noted that Topamax can pass into the newborn mother’s milk, which can, in turn, cause newborns to be exposed to trace amounts during breastfeeding.
Breastfeeding while taking Topamax can cause the following symptoms in newborns:
- Appetite loss
- Weight loss
If you believe your child may have been affected by Topamax, contact your physician immediately.
Topamax Timeline Events
|1979||Topamax is developed by Ortho-McNeil Neurologics and Noramco, Inc.—both divisions of Johnson & Johnson.|
|1996||Topamax is approved for treatment of epileptic seizures.|
|1997||Study by North American Antiepileptic Drug (NAAED) Pregnancy Registry begins.|
|2001||Possible link between Topamax and blindness or glaucoma.|
|2004||Topamax is approved for treatment of migraine headaches.|
|2006||Generic topiragen is approved.|
|2008||(April) Link between Topamax and birth defects (cleft palate): study published in American Academy of Neurology|
|2009||Topamax patent expires and generic forms of the drug flood the marketplace.|
|2010||(March) Off-label promotion of Topamax results in Whistleblower lawsuits and $80 million in settlements.|
|2011||The North American Antiepileptic Drug Pregnancy Registry finds that 1.4 percent of infants exposed to topiramate during the first trimester—or about 1 of every 65 infants developed cleft lip and/or palate. Those findings confirm data being reported by officials in the United Kingdom.|
|2011||(March 4) FDA warning changed to category D, which means: “There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.” This information was taken from Drugs.com list of FDA category ratings.|
|2014||(March) Simmons Hanly Conroy secures $3 million verdict against Janssen Pharmaceuticals.|