Topamax-Used for Seizures & Migraine Headaches-Linked to Birth Defects

Topamax (topiramate) is a drug approved to treat certain types of seizures and also migraine headaches. It has been linked to birth defects in infants whose mothers took Topamax while pregnant. In 2008, the U.S. Food and Drug Administration also issued a warning of an increased risk of suicidal thoughts and behaviors in patients taking topiramate-containing drugs.

Topamax has also been aggressively marketed for many uses for which it is not FDA-approved. These include bipolar disorder, cluster headaches, eating disorders, obesity, fibromyalgia, depression, post-traumatic stress disorder (PTSD), alcoholism, sleep disorders, sleep-eating disorders, infantile spasms, autism, periventricular leukomalacia in preterm infants after an hypoxic-ischemic injury, essential tremor, bulimia nervosa, obsessive-compulsive disorder, smoking cessation, idiopathic intracranial hypertension, neuropathic pain, and cocaine dependence.

The drug’s manufacturer may not have provided adequate warnings or conducted enough studies on this drug before it was put on the market. For this reason, patients who were prescribed this drug and later suffered serious medical complications have the right to hold the manufacturer responsible. Affected patients include:

• Women who were on Topamax and later gave birth to a child with a birth defect
• Anyone who attempted suicide and suffered severe, permanent injury as a result
• Families of anyone who committed suicide

Although a lawsuit cannot ease the pain or loss of a loved one, it can help compensate for losses in income, quality of life and suffering. An experienced Topamax attorney with Janet, Jenner & Suggs can review your situation and advise you. All consultations are free of charge.

Consumer Alert for Pregnant Women

Pregnant women who took the drug Topamax are at an increased risk for delivering a child with an oral birth defect such as a cleft palate. An infant born with a cleft palate or lip may experience breathing or feeding problems and generally will require surgery within 12 to 18 months. These children may also require additional surgeries as they age, for dental or cosmetic issues. Some of these defects may also lead to sinus and hearing problems.

The U.S. Food and Drug Administration in March, 2011 ordered stronger warnings placed on these drugs, after a review of pregnancy databases showed a higher risk for cleft lip and cleft palate. The problem occurs when parts of the lip or palate don’t completely fuse early in the first trimester, when women may not know they are pregnant.

About Topamax/Topiramate

Topamax, known as topiramate in generic form, has been on the market since 1996. It is known to be an effective remedy for epilepsy and prevention of migraine. Many women, including expectant mothers, are known to have taken this medication before the FDA issued its latest warning. Between 2007 and 2010, 32 million prescriptions were dispensed in the U.S. for over 4 million patients. During this time, studies show fetuses exposed to Topamax had a 1.4 percent rate of oral defects, more than three times that of other seizure drugs.

Even though early laboratory testing showed the drug produced fetal deformities in animals, it was marketed without any clear warnings to women about birth defect risks.

In 2011, the FDA announced it is increasing the warning requirement on Topamax to say that it should not be taken by women who are pregnant or who may become pregnant.

Topamax and Suicidal Thoughts and Behaviors

In 2008, the FDA announced it had found a link between 11 drugs used to treat seizures and an increase in suicidal thoughts and behaviors. The drugs included Topmaz, Lamictal, Lyrica, Tegretol and Trileptal. Topamax is also approved to treat migraines, and Lyrica is approved to treat certain pain conditions from diabetes, shingles and fibromyalgia.

The FDA issued the warning after reviewing data from clinical studies involving 44,000 patients. Among its findings was that patients receiving any of the 11 drugs had about twice the risk of suicidal behavior or thoughts. The FDA said increased risk was seen as early as one week after starting the drug, and continued through 24 weeks.

Legal Help for Victims of Topamax (topiramate) Injuries

If you or a loved one were treated with Topamax or a similar drug and suffered any of the above injuries, you may have valuable legal rights. Please fill out our online form, or call us toll-free 1-877-My-Advocates (1-877-692-3862) to discuss your case with one of our pharmaceutical injury lawyers today.