About the drug:

Topamax (topiramate) is an anticonvulsant drug first approved by the FDA in 1996 to help treat certain types of seizures in patients with epilepsy. Since then, it has also been approved to prevent migraine headaches and is also used off label to treat many conditions, including the following:

• Bipolar mood disorder
• Alcoholism
• Obesity/binge eating
• Post Traumatic Stress Disorder
• Essential tremors
• Bulimia nervosa
• OCD
• Smoking cessation
• Idiopathic intracranial hypertension
• Neuropathic pain
• Cluster headaches
• Cocaine dependence
• Borderline Personality Disorder

Topamax was originally produced by Ortho-McNeil Neurologics and Noramco, Inc., both divisions of Johnson & Johnson. From January 2007 through December 2010, approximately 32.3 million topiramate prescriptions were dispensed, and approximately 4.3 million patients filled topiramate prescriptions from the outpatient retail pharmacies in the United States.

Since the drug has been on the market, users of the drug have experienced significant problems. The FDA has notified prescribers that topiramate can cause acute myopia and secondary angle closure glaucoma, which causes impaired vision (and, potentially, blindness). Topiramate has also been associated with a significant increased risk of suicide.

Birth Defects

On March 4, 2011, the FDA notified healthcare professionals and patients of an increased risk of development of cleft lip and/or cleft palate in infants born to women treated with Topamax during pregnancy. Findings from the FDA follow:

• 1.4% of infants exposed to the drug suffer from oral clefts
•  .38% to .55% of infants exposed to OTHER anti-epileptic drugs suffer from oral clefts
•  .07% of the general population suffer from oral clefts

Studies show:

• Topamax increases the risk of oral clefts by nearly 20%, or 4 times more than other antiepileptic drugs.
• The same study showed that Topamax users are 20 times more likely to give birth to children with oral clefts than women not taking an antiepileptic drug.

Due to this development, Topamax has been moved from pregnancy category C to category D.

• Category C: "Caution is advised, but the benefits of the medication may outweigh the potential risks. There have been no well-controlled studies in women, but studies in animals have shown some harm to the fetus."
• Category D: "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 assignment to this category means that major precautions should be taken when a woman is of childbearing age and taking Topamax. Topamax should not be taken unless the benefits strongly outweigh the risks, such as potential permanent injury or death.

Important Facts

The FDA warning comes after results from North American Antiepileptic Drug Pregnancy Registry data showed a high rate of oral birth defects in babies born to mothers who underwent topiramate therapy for epilepsy or migraine. The new warning followed several years of controversy in regards to the safety and efficacy of the drug, as well as marketing practices used by at least one manufacturer.

The FDA waited fourteen years to issue a warning in this regard, meaning thousands of pregnant and expectant mothers have taken the drugs without knowing the impact it would have on their fetus. The absence of this information has caused possibly hundreds of oral birth deformities in the past fourteen years. There are safer alternatives to Topamax to use during pregnancy that do not have such a high risk of birth defects.

In 2008, a small study was published in the Neurology journal regarding the high prevalence of birth defects for Topamax users. The study was the first research that linked Topamax to risk of birth defects in humans, finding that Topamax users were 11 times more likely to give birth to children with oral clefts. This study, even with its size limitation, should have been enough to prompt Johnson & Johnson to conduct further research and warn the public immediately.

Have you or a loved one been injured as a result of Topamax/topiramate?

If you or a loved one have experienced any of the described effects associated with Topamax, please contact us by filling out our online contact form, or call our office for a complementary consultation.

We have been representing victims of defective devices nationwide for over 27 years and have the resources and expertise to hold manufacturers accountable.