Topamax, an anti-seizure and anti-migraine medication has been on the market since 1996. Over the course of its history it has been linked to side effects from eye problems to an increased risk of suicidal tendencies.
Although there’s been no official recall of Topamax, otherwise known as topiramate, due to its adverse effects on the unborn children of women taking the drug, the FDA has increased the drug’s warning label and pregnancy category rating. After several studies showing compelling evidence linking Topamax to cleft palate birth defects, the FDA is encouraging doctors to seek alternative treatments to the seizure and migraine drug.
An unrelated recall of Topamax was issued in April 2011 due to a strong and offensive odor coming from the pills. Despite the fact that there hasn’t yet been a recall of the drug due to it’s connection to birth defects, the FDA has taken other steps to limit the use of the drug by pregnant women.
FDA Restricts Topamax
Topamax, previously a Pregnancy Category C, has been downgraded by the FDA to a Pregnancy Category D, the second lowest categorization, after several studies conducted by the FDA established a strong link between the drug and cleft palate birth defects. As an added danger, Topamax has been shown to decrease the effectiveness of birth control.
In light of the studies linking Topamax to cleft palate, the FDA is recommending that doctors to use extreme caution in prescribing the drug to women of childbearing age, especially when there are readily available alternative treatments.
The Cost of Cleft Palate
Research shows that taking Topamax while pregnant increases the risk that your child will have a cleft palate birth defect by 20 times.
Although cleft palate is generally not life threatening, the severity of cleft palate can range from a small notch in the lip to a groove that runs into the roof of the mouth and nose. The surgery required to correct it can be very costly, and sometimes more than one surgery is needed to fully remedy the facial disfigurement. Left untreated, cleft palate can cause ear infections and prevent proper speech and nutrition.
Call Today for a Free Legal Consultation
If you or your child has suffered from the effects of Topamax related birth defects, submit this simple secure form for a free and confidential evaluation to learn more about your eligibility to file a Topamax cleft palate birth defect lawsuit. Legal action is the best way to recover the most compensation for your medical expenses and pain and suffering.