Topamax Linked to Cleft Palate in Unborn Babies

The following injuries or side effects have been reported in newborns whose mother took Topamax during their first trimester of pregnancy:

If you or someone you know took Topamax during the first trimester of pregnancy and had a newborn with a cleft palate or cleft lip, it may be important to contact an attorney who can help you protect your potential legal claim. Monsour Law Firm is an experienced law firm helping patients and families.
Study Shows that Risk of Oral Cleft Birth Defect is 20 Times Higher For Pregnant Women Taking Topamax Than Those Not Treated

Topamax Linked to Cleft Palate in Newborns

The epilepsy and migraine drug Topamax (topiramate) increases the risk for birth defects such as cleft lip and cleft palate in babies born to women who use the medication during pregnancy.
New data from the North American Antiepileptic Drug (AED) Pregnancy Registry indicates an increased risk of oral clefts in infants exposed to topiramate during the first trimester of pregnancy. Similar findings have also been noted in another pregnancy registry in the United Kingdom.
Topiramate is an anticonvulsant medication used to treat epilepsy patients who have certain types of seizures. It is also approved to prevent migraine headaches. It is not approved to relieve the pain of migraines. Some physicians prescribe Topamax for unapproved uses for other conditions, such as treatment of psychiatric disorders, OCD, essential tremor, cluster headaches, alcoholism and weight loss.
Based on the data, Topamax (topiramate) must now display a stronger warning on its label. The pregnancy category will be changed to Pregnancy Category D. This means that there is positive evidence of human fetal risk based on human data, but the potential benefits of the drug in pregnant women may outweigh the risks in certain situations. More information about the Pregnancy Categories can be found in the FDA's Drug Safety Communication.

Cleft Lip and Cleft Palate Birth Defects

Cleft lip and cleft palate are birth defects that occur when parts of the developing lip or palate do not completely fuse together during the first trimester of pregnancy. In many cases, a woman may not even know she is pregnant at the time the cleft lip or palate is forming. The defects 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. Surgery often is performed during the first year of life to close the lip and palate. Most children do well after treatment.
Oral clefts are present at birth and cannot occur at a later date. If an infant was exposed to Topamax (topiramate) during pregnancy but was born without a cleft lip or palate, there is no chance of developing one after birth.

Topamax and Pregnancy Risks

Topamax was previously labeled by the FDA as a category C pregnancy drug (see description below). Recently released data from the North American Antiepileptic Drug Pregnancy Registry shows an increased risk of oral clefts in infants exposed to topiramate during the first trimester of pregnancy. Similar findings have also been noted in another pregnancy registry in the United Kingdom. As a result, Topamax (topiramate) must now have a stronger warning on its label. The pregnancy category for Topamax will be changed to Pregnancy Category D.

FDA Drug Categories for Pregnancy

The FDA has established five categories to indicate the potential of a drug to cause birth defects if used during pregnancy. The categories are determined by the reliability of documentation and the risk to benefit ratio. The categories are:
Category A: Adequate and well-controlled studies in pregnant women/animals show no fetal risk in the first trimester of pregnancy
Category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Category D: 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.
Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
Category N: FDA has not classified the drug.

Topamax has been linked for risk of development of cleft palate in newborns as well as memory problems, mood swings, depression, uncontrollable shaking of parts of the body, osteoporosis, rickets, and the potential for slowing growth in children. Recent studies by the FDA have ordered label changes and safety alerts to all Topamax medication prescribed.

What is Topamax (Topiramate) and what is it used to treat?

Topamax or its clinical name, Topiramate, is prescribed to treat certain types of seizures in people who have epilepsy. Topiramate is also used with other medications to control seizures in people who have Lennox-Gastaut syndrome (a disorder causings seizures and developmental delays). Topiramate can also be used to prevent migraine headaches, but not to relieve the pain of migraine headaches once they occur. Topiramate is classified as an anticonvulsant and works by decreasing abnormal excitement in the brain.

FDA LABEL CHANGE AND SAFETY WATCH ON TOPAMAX
Topamax (topiramate): Label Change - Risk For Development of Cleft Lip and/or Cleft Palate in Newborns
[Posted 03/04/2011]
 
AUDIENCE: Neurology, OB/GYN

ISSUE: FDA notified healthcare professionals and patients of an increased risk of development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with Topamax (topiramate) during pregnancy. Because of new human data that show an increased risk for oral clefts, topiramate is being placed in Pregnancy Category D. Pregnancy Category D means there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women may be acceptable in certain situations despite its risks. The patient medication guide and prescribing information for Topamax and generic topiramate will be updated with the new information.

BACKGROUND: Topiramate is an anticonvulsant medication approved for use alone or with other medications to treat patients with epilepsy who have certain types of seizures. Topiramate is also approved for use to prevent migraine headaches. The new data was from the North American Antiepileptic Drug (NAAED) Pregnancy Registry.

RECOMMENDATION: Before starting topiramate, pregnant women and women of childbearing potential should discuss other treatment options with their health care professional. Women taking topiramate should tell their health care professional immediately if they are planning to or become pregnant. Patients taking topiramate should not stop taking it unless told to do so by their health care professional. Women who become pregnant while taking topiramate should talk to their health care professional about registering with the North American Antiepileptic Drug Pregnancy Registry, a group that collects information about outcomes in infants born to women treated with antiepileptic drugs during pregnancy.
 
See Drug Safety Communication for additional information, including a data summary and recommendations for healthcare professionals and patients.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm245777.htm

FDA Topamax side effect report:
http://www.fda-reports.com/Topamax.html

Pharmaceutical Today series of articles on Topamax
http://pharmaceuticals.einnews.com/news/topamax