ALERT! FDA Drug Safety: Risk of oral clefts
in children born to mothers taking Topamax (topiramate)

FDA NEWS RELEASE

Did You Or a Loved One Suffer From using Topamax?

For Immediate Release: March 4, 2011

FDA: Risk of oral birth defects in children born to mothers taking topiramate

New data suggest that the drug Topamax (topiramate) and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy, the U.S. Food and Drug Administration said today.

Before prescribing topiramate, approved to treat certain types of seizures in people who have epilepsy, health care professionals should warn patients of childbearing age about the potential hazard to the fetus if a woman becomes pregnant while using the drug.
Topiramate also is approved to prevent migraine headaches, but not to relieve the pain of migraines. 

“Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Alternative medications that have a lower risk of birth defects should be considered.”

Cleft lip and cleft palate, collectively called oral clefts, are birth defects that occur when parts of the lip or palate do not completely fuse together early in the first trimester of pregnancy, a time when many women do not know they are pregnant. 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 to close the lip and palate and most children do well after treatment.

Data from the North American Antiepileptic Drug (AED) Pregnancy Registry indicate an increased risk of oral clefts in infants exposed to topiramate during the first trimester of pregnancy. Infants exposed to topiramate as a single therapy experienced a 1.4 percent prevalence of oral clefts, compared with a prevalence of 0.38 percent – 0.55 percent in infants exposed to other antiepileptic drugs.

Infants of mothers who did not have epilepsy and were not being treated with other antiepileptic drugs had a prevalence of 0.07 percent. Similar data from the United Kingdom Epilepsy and Pregnancy Register supported the North American AED Pregnancy Registry data.

Based on the data, topiramate will have a stronger warning in its prescribing information (labeling). 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. The FDA previously designated the drug as Pregnancy Category C because of the lack of human data. More information about the Pregnancy Categories can be found in the FDA’s Drug Safety Communication1.

The patient medication guide and prescribing information for Topamax and generic topiramate will be updated with the new information.

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 Registry2, a group that collects information about outcomes in infants born to women treated with antiepileptic drugs during pregnancy.  

FDA Drug Safety Communication: Risk of oral clefts in children born to mothers taking Topamax (topiramate)

 Safety Announcement
 [03-04-2011] The U.S. Food and Drug Administration (FDA) is informing the public of new data that show that there is an increased risk for the development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with Topamax (topiramate) during pregnancy.

The benefits and the risks of topiramate should be carefully weighed when prescribing this drug to women of childbearing age, particularly for conditions not usually associated with permanent injury or death. Alternative medications that have a lower risk of oral clefts and other adverse birth outcomes should be considered for these patients. If the decision is made to use topiramate in women of childbearing age, effective birth control should be used. Oral clefts occur in the first trimester of pregnancy before many women know they are pregnant.
Topiramate was previously classified as a Pregnancy Category C drug, which means that data from animal studies suggested potential fetal risks, but no adequate data from human clinical trials or studies were available at the time of approval. However, 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.
(see Data Summary)

 Additional Information for Patients 

• If you take topiramate during pregnancy, there is a higher risk that your baby will develop a cleft lip and/or cleft palate. Oral clefts happen early in pregnancy, before many women even know they are pregnant. For this reason, women of childbearing age should talk to their healthcare professionals about other treatment options.
• Women of childbearing age who do decide to take topiramate and are not planning a pregnancy should use effective birth control (contraception) while taking topiramate. Women should talk to their healthcare professionals about the best kind of birth control to use while taking topiramate.
• Before you start topiramate, you should tell your healthcare professional if you are pregnant or are planning to become pregnant. Healthcare professionals may discuss other treatment options with you.
• You should tell your healthcare professional right away if you become pregnant while taking topiramate. You and your healthcare provider should decide if you will continue to take topiramate while you are pregnant.
• Topiramate should not be stopped without talking to a healthcare professional, even in pregnant women. Stopping topiramate suddenly can cause serious problems. Not treating epilepsy during pregnancy can be harmful to women and their developing babies.
• If you become pregnant while taking topiramate, you should talk to your healthcare professional about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect additional information about the safety of antiepileptic drugs during pregnancy.
• Topiramate passes into breast milk, but its effects on developing babies remain unknown. You should talk to your healthcare professional about the best way to feed your baby if you take topiramate.
• You should report any side effects you experience to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of the page.
• You should read the Medication Guide when picking up a prescription for topiramate. It will help you understand the potential risks and benefits of this medication.

Additional Information for Healthcare Professionals

• You should inform women of childbearing age of the increased risk for oral clefts when topiramate is used in the first trimester of pregnancy.
• You should weigh the benefits and risks of topiramate when prescribing this drug to women of childbearing age, particularly when treating a condition not usually associated with permanent injury or death. Alternative medications that have a lower risk of oral clefts and other adverse birth outcomes should be considered. Healthcare professionals should discuss the relative risks and benefits of appropriate alternative therapies.
• If the decision is made to prescribe topiramate to women of childbearing age, healthcare professionals should recommend use of effective contraception for women who are not planning a pregnancy, keeping in mind the potential for a decrease in hormonal exposure and a possible decrease in contraceptive efficacy when using estrogen-containing birth control with topiramate.
• You should inform patients of the North American Antiepileptic Drug (NAEED) Pregnancy Registry and encourage patients who become pregnant to enroll by calling 1-888-233-2334.
• You should report adverse events involving topiramate to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of the page.

Data Summary

Data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry indicate an increased risk of oral clefts in infants exposed to topiramate monotherapy during the first trimester of pregnancy. The prevalence of oral clefts was 1.4% compared to a prevalence of 0.38% - 0.55% in infants exposed to other antiepileptic drugs (AEDs), and a prevalence of 0.07 % in infants of mothers without epilepsy or treatment with other AEDs. The relative risk of oral clefts in topiramate-exposed pregnancies in the NAAED Pregnancy Registry was 21.3 as compared to the risk in a background population of untreated women (95% Confidence Interval:7.9 – 57.1). The UK Epilepsy and Pregnancy Register reported a similarly increased prevalence of oral clefts (3.2 %) among infants exposed to topiramate monotherapy, a 16-fold increase in risk compared to the risk in their background population (0.2%).

The benefits and the risks of topiramate should be carefully weighed when prescribing this drug for women of childbearing age, particularly when topiramate is considered for a condition not usually associated with permanent injury or death. Appropriate alternative treatment should be considered . Inform women of childbearing age of the increased risk for having a baby with an oral cleft if they become pregnant while using topiramate.

Nationwide Topamax Injury Litigation – Cleft Palate

At Topamax Lawsuit Center, we have a network of specialized attorneys and registered nurses, dedicated to helping people who have suffered severe medical problems resulting from use of a dangerous drug, and specifically, the drug Topamax. We are currently providing free consultation and case evaluation for Topamax birth defects on a contingency basis. At Topamax Lawsuit Center, you can rest assured that you will be represented by the very best specialized attorney that will fight for your rights and seek the maximum extent of compensation for the injuries and damages suffered by you and your child.

E-mail us or call us at 1-888-644-3578 for a free consultation with a member of our experienced pharmaceutical litigation team.

We handle all Topamax birth defect cases on a contingency basis. You pay NO FEES for expenses, unless we recover a settlement for YOU.

Topiramate (brand name Topamax) is an anticonvulsant (antiepilepsy) drug. It was originally produced by Ortho-McNeil Neurologics and Noramco, Inc., both divisions of Johnson & Johnson. It was discovered in 1979 by Bruce E. Maryanoff and Joseph F. Gardocki during their research work at McNeil Pharmaceutical.

We are affiliated with a network of pharmaceutical litigation lawyers that have been successful handling these types of cases for many years. Our team has successfully gone up against some of the largest drug companies in the world. We have the knowledge and resources to handle your Topamax claim. We are here to stand up for your rights.  To discuss your potential Topamax case with no upfront fees, contact us at 1-888-644-3578.

Was your child injured by Topamax?

Topamax Lawsuit Center Accepting Cases Now For Birth Defects:

• Oral Clefts - Cleft Palate

• Free Initial Consultation With A
  Registered Nurse On Staff