Topiramate in Pregnancy Warning - Consumer Justice Foundation

Topiramate in Pregnancy Warning

Written by Andrew Sarski on July 1, 2011
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The Antiepileptic Topiramate for Migraine Headaches

Although the antiepileptic drug topiramate was initially developed as a treatment for epilepsy, it is now considered one of the most frequently prescribed migraine medications on the U.S. market. Topiramate is sold under the brand name Topamax, which is manufactured by Ortho-McNeil Pharmaceutical, a subsidiary of Johnson & Johnson. Topamax was approved by the FDA in 1996 for the treatment of epilepsy, and the FDA added an indication in 2004 for the prevention of migraine headaches. More than 30 million people in the United States alone suffer from migraine headaches, a condition which affects more women of childbearing age than any other population in the country.

Pregnancy Risks and Potential Topiramate Birth Defects

The FDA recently elevated the pregnancy category of topiramate from C to D, which is the second highest category available when evaluating the pregnancy risks of pharmaceutical drugs. Category D is reserved for drugs which positive human evidence shows may cause serious harm to a fetus when taken during pregnancy. The FDA also issued a safety announcement earlier this year in which the agency warned patients and healthcare providers about the increased risk of oral cleft birth defects among infants exposed to topiramate during pregnancy. The FDA decision was largely influenced by two topiramate birth defect studies in which researchers sought to examine the adverse effects of fetal exposure to topiramate (Topamax). According to the North American Antiepileptic Drug (NAAED) Pregnancy Registry, infants whose mothers take topiramate while pregnant many be more than twice as likely to develop oral cleft birth defects like cleft lip and cleft palate, compared to infants exposed to other antiepileptic drugs in utero.

A study published in the journal Neurology in 2008 indicated that infants whose mothers took topiramate while pregnant were an alarming fourteen times more likely to develop genital birth defects like hypospadias, and eleven times more likely to develop oral clefts like cleft lip or cleft palate, compared to the expected rate among the general population. Researchers also determined that this birth defect risk was even higher among infants whose mothers took topiramate in combination with valproate, or Depakote, another popular antiepileptic drug.

Topiramate Use in Women of Childbearing Age

Research shows that Topamax and other topiramate-containing antiepileptic drugs may also decrease the effectiveness of birth control pills, potentially leading to unplanned pregnancy. Oral contraceptives, or birth control pills, use hormone regulation to prevent pregnancy in women. New information shows that topiramate may increase the metabolism of estrogen and progesterone, leading to the failure of oral contraceptives and increasing the likelihood of pregnancy. This is especially dangerous because topiramate has also been associated with an increased risk of birth defects, which can cause life-altering damage to children exposed to the drug during pregnancy.

Most birth defects occur during the first trimester of pregnancy, before many women are even aware they are pregnant. Unfortunately, because nearly half of all pregnancies are unplanned, all women of childbearing age taking topiramate (Topamax) may be at risk of unknowingly causing catastrophic harm to their unborn child. Due to this potential for causing serious fetal harm, topiramate may no longer be considered safe in the treatment of migraine headaches, especially for women of childbearing age. If you took topiramate for migraine prevention and gave birth to a child with serious birth defects, consult a Topamax attorney immediately. Your child may be entitled to lifetime care or financial compensation for his injuries, which you can collect by filing a topiramate lawsuit against Ortho-McNeil Pharmaceutical (Johnson & Johnson). You are not at fault for birth defects potentially caused by the antiepileptic drug topiramate. With the help of a topiramate attorney, you and your child can receive the financial reimbursement you deserve.

Posted Under: FDA - Food and Drug Administration
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