Topamax Birth Defects

Topiramate, commonly called Topamax, is a drug most often used to treat epilepsy.1 The drug is designed and approved by the FDA to treat seizures associated with epilepsy and also to prevent migraines.2 Often times, Topamax is also used off-label as a treatment for obesity, bipolar disorder, or even alcoholism.3 While for many the drug causes positive effects, the drug also poses serious side effects.4 Those taking the drug can face drowsiness, dizziness, loss of coordination, tingling in the hands or feet, loss of appetite, confusion, nervousness, or even speech and language problems.5 In addition to the warnings for those taking Topamax, the FDA recently warned of the potential dangers the drug poses to pregnant mothers.6 Studies have found that Topamax, when taken while pregnant, significantly increases the child’s chance of serious birth defects, more specifically cleft palate or cleft lip.7 In a recent study, doctors found that children exposed to the drug during pregnancy had a 1.4% rate of mouth defects, whereas those exposed to other seizure medicines had a risk of only about 1/3 that number.8 Further, children who weren’t exposed to any anti-seizure medication faced only a .07% risk of defects.9

Cleft lip or cleft palates are conditions caused during pregnancy that affect the baby’s mouth and lip.10 The condition occurs when the child’s lip or mouth do not form properly. Children experiencing these conditions often have problems with feeding and talking, ear infections, hearing loss, and problems with their teeth.11 Cleft palate and cleft lip are both conditions that require surgery.12 Doctors recommend that the surgeries occur within the first few months of life.13 While the first surgery is essential, most children require further surgeries later in life in order to correct the condition.14 Surgeries not only work to repair the visible problems, but also help to improve breathing, hearing, speech, and language.15 In addition to surgeries, many children born with cleft lip or cleft palate receive special dental and orthodontic care later in life along with speech therapy.16

In response to these findings, the FDA recently warned of the problems prescribing the drug to women of child bearing age.17 The FDA warned that medical professionals should carefully consider prescribing the drug to those women and suggests strongly that they use an alternative, if available.18 After similar studies were conducted in Europe, the FDA decided that Topamax and its generic form will have a stronger warning label on the packaging.19 In addition, the FDA changed the classification the drug received for birth defects, placing it in a must more severe category that indicates there has been strong evidence that the drug causes fetal risk.20

1 Topamax Oral, WEB MD, http://www.webmd.com/drugs/mono-6019-TOPIRAMATE+-+ORAL.aspx?drugid=14494&drugname=Topamax+Oral.
2 Topamax Oral, supra note 1.
3 Jennifer Warner, New Birth Defect Warning for Topamax, WEB MD, http://www.webmd.com/epilepsy/news/20110304/new-birth-defect-warning-for-topamax.
4 Topamax Oral, supra note 1.
5 Topamax Oral, supra note 1.
6 Warner, supra note 3.
7 Warner, supra note 3.
8 FDA Warns of Birth Defects with Topamax, USA TODAY, http://usatoday30.usatoday.com/news/health/medical/health/medical/story/2011/03/FDA-warns-of-birth-defects-with-Topamax/44498504/1.
9 FDA Warns of Birth Defects, supra note 8.
10 Facts About Cleft Lip and Cleft Palate, CENTERS FOR DISEASE CONTROL AND PREVENTION, http://www.cdc.gov/ncbddd/birthdefects/cleftlip.html.
11 Facts about Cleft Lip, supra note 10.
12 Facts about Cleft Lip, supra note 10.
13 Facts about Cleft Lip, supra note 10.
14 Facts about Cleft Lip, supra note 10.
15 Facts about Cleft Lip, supra note 10.
16 Facts about Cleft Lip, supra note 10.
17 Risk of Oral Birth Defects in Children Born to Mothers Taking Topiramate, FDA, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm245594.htm.
18 Risk of Oral Birth Defects, supra note 17.
19 Warner, supra note 3.
20 Warner, supra note 3.

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