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Topamax® Lawsuit 2011

Pregnant women should be aware that the drug Topamax® poses serious health risks to the unborn child. On March 4, 2011, the United States Food and Drug Administration issued a warning that the drug increases the risk of oral cleft defects when used by women during the first trimester of pregnancy. Oral cleft defects include cleft lip and cleft palate. Oral cleft defects occur when parts of the lip or palate do not completely fuse together and can lead to increased ear infections and other problems. They often require corrective surgery.

About Topamax®

Topamax®, known generically as topiramate, was first approved by the FDA in 1998 for the treatment of seizures due to epilepsy. In 2004, it was approved for the prevention of migraine headaches and has since become widely used in the treatment of migraines. Between January 2007 and January 2010, over 32 million prescriptions for Topamax have been dispensed.

FDA Warnings

The FDA found that the risk for these types of birth defects is 11 times higher in women who have used Topamax while pregnant than in that of the general population. Data from the North American Antiepileptic Drug Pregnancy Registry found the rate of cleft defects is 1.4% in women who used Topamax as a single therapy; in women who used it in combination with other antiepileptic drugs, the rate is between .38% - .55%. For women not treated for epilepsy at all, the rate is .07%.

The FDA is advising health care professionals to warn their female patients of childbearing age of the potential dangers before prescribing Topamax. The FDA is also requiring stronger warning labels for the drug. In light of recent findings, Topamax has had its status as a Pregnancy Category C drug revised to a Pregnancy Category D. Category C drugs have shown fetal risks in animal testing, but have not shown conclusive human risks. Category D drugs have been found to cause harm to human fetuses, but their use may be warranted in instances where the benefits outweigh the risks. Epileptic seizures in pregnant women may pose risks to their unborn and may justify use of the drug. For the treatment of migraines, there may be safer alternatives. Women need to consult their physicians and evaluate the risks involved in making a decision on whether to take Topamax.

When Taking Topamax®

Women who could become pregnant while taking the drug should use an effective method of birth control, preferably a non-hormonal one. It is believed that the drug may also interfere with hormonal birth control such as birth control pills.

Manufacturer Liability

Ortho-McNeill manufactures Topamax and several additional drug makers produce the generic form topiramate. Johnson & Johnson, owner of Ortho-McNeill, says the medication's labeling already informs users of the risks. But women who believe their pregnancies have been adversely affected by Topamax are taking Ortho-McNeill and Johnson & Johnson to task through lawsuits. They allege that manufacturers failed to adequately research the birth defect dangers and failed to disclose those dangers to users.

If you or a loved one has experienced serious side effects, birth defects or health complications with Topamax, contact Newsome Law Firm and fill out a case evaluation form today. Our team of attorneys has experience specific to complications associated with prescription medication. Not only can they give you the legal guidance you need, they can help you get the compensation you deserve.