Topamax Linked to Cleft Lip, Cleft Palate, and Other Serious Birth Defects in Children

Topamax, know in its generic form as Topiramate, was first produced in 1979 by Ortho-McNeil Neurologics or Noramco, Inc. a subsidiary of Johnson & Johnson. While Topamax was originally approved to treat epilepsy, a disorder characterized by uncontrolled seizures, the FDA also approved Topamax for use in treating severe migraines and headaches in 2004. Generic versions of Topamax became available in September 2006. Topamax is also often prescribed off-label to for Bi-polar disorders and corresponding symptoms. It is estimated that there have been approximately 32 million prescriptions for Topamax, or its generic form.

Research has linked Topamax with several serious and possibly debilitating side effects, including a heightened risk of cleft lip and cleft palate, collectively known as “cleft defects”. Cleft defects take place when the body does not fuse properly during the first trimester of pregnancy. In March of 2011, the FDA instituted a “Black Box” warning for Topamax and Topamax generics. Based on data from the North American Antiepileptic Drug (AED) Pregnancy Registry, researchers determined that infants exposed to Topamax in the first trimester developed oral clefts 1.4% of the time. When compared to the prevalence of cleft defects for other antiepileptic medications, which was only .38-.55%, and in mothers who did not use any type of antiepileptic medication, only .07%, a clear, statistically significant correlation was documented. Given this data, the FDA also required that Topamax be moved from a Category C pregnancy drug, a categorization indicating “no adequate adverse effects on human fetuses”, to a Category D pregnancy drug, indicating “positive evidence for human fetal risk”.

In addition to cleft defects, Topamax has been linked to other side effects such as severe rashes and swelling, unexplained pain, fever, fatigue, unexplained eye pain, and unusual mood changes.

DescriptionGiven the results of several studies, most notably that of the AED Pregnancy Registry, it is estimated that children born to mothers taking Topamax are over 20 times more likely to deliver babies with some type of birth defect or deformity. While generally non-fatal, these birth defects such as cleft lip and cleft palate can cause significant emotional hardship for young children and financial hardship for families that have to pay for serious surgeries.

Other than cleft lip and cleft palate, Topamax has also been associated with heart defects, lung defects, brain defects, and Arm and Limb defects. Unlike cleft lip and cleft palate, deformities in these regions could prove to be fatal and cause early unexplained death.

As early as 2008, the manufacturers of Topamax were aware of the potential risk associated with supplying Topamax to mothers in there first trimester, especially with regard to the increased risk of cleft palate and cleft lip. Women were not properly warned about the side effects associated with Topamax and if they were, they may have been able to use the drug in a later stage of preganancy or stop using the drug overall.

Symptoms

Child:

Cleft Lip

• Separation of the lip
• Separation of the palate
• Misaligned or oddly shaped upper lip
• Change or distortion in nose shape
• Problems with feeding
• Misaligned teeth
• Speech difficulties

Cleft Palate

• Clear facial defects
• Liquids leaking from nose
• “Weak Suck”
• Difficulty swallowing
• Reoccurring gagging
• Reoccurring choking

Topamax is also linked to birth defects affecting:

• The Heart
• The Lungs
• “Weak Suck”
• The Arms, Legs, and Hands
• The Brain

Mother:

• Difficulty Breathing
• Blurred vision and Eye Pain
• Unexplained pain
• Tremors
• Trouble walking
• Fever
• Nausea
• Mood Changes

Reference Information

• FDA Drug Safety Communication: Risk of oral clefts in children born to mothers taking Topamax (topiramite) – 03/04/2011
• CJF Warns Mothers on Topamax Increase Risk of Chidren with Oral Clefts – 07/12/2011
• Migraine Medicine Topamax Suspected in Birth Defect Claims – 07/14/2011
• AED: Information for Women