Since 1995 more than 4 million people worldwide have turned to Topamax to treat seizures, however in 2004 it was also approved for use in reducing migraines and is now considered the #1 migraine prevention medication.
Millions of patients worldwide have been treated with Topamax for a variety of medical conditions. Some other conditions often treated with Topamax include, but not limited to:
- Alcohol dependency
- Weight loss
- Eating disorders
- Bipolar disorder
Although the migraine drug has been tied to some side-effects, the Food and Drug Administration (FDA) issued a warning in 2011 regarding Topamax. Since then a label change was requested in order to better inform the public of complications linked to the drug; unfortunately hundreds had already been affected.
According to Janssen Pharmaceuticals, large, well-controlled clinical trials of the product involved more than 1,700 patients. Through extensive patient experience they noted several common side-effects, including:
- Weight loss
- Ocular issues
- Difficulty concentrating
Despite extensive clinical trials, there were some risks tied to Topamax that the manufacturer failed to warn the public about. In 2011 the FDA notified healthcare professionals that babies of women using Topamax while pregnant had an increased risk of developing birth defects. In fact, infants born to mothers using Topamax were 21 times more likely to develop cleft lip and cleft palate.
Other birth defects linked to the use of Topamax by women while pregnant include, but not limited to:
- Spina bifida
- Craniofacial defects
- Neural tube defects
- Lung and heart issues
- Limb malformation(s)
Topamax may also be passed into breast milk but its effect on developing babies is not yet known. Due to the findings on birth defects, the FDA placed Topamax in the pregnancy category D which signifies that there is positive evidence of fetal human risk.
Many lawsuits allege that Janssen Pharmaceuticals failed to provide customers with an adequate warning and thus breached its legal duty to protect consumers. If Topamax had warned consumers of the dangers of their product the consumer may have opted for a safer drug or form of treatment.
In 2013 a Philadelphia jury awarded the family of a child born with congenital defects, caused by the mother’s use of Topamax, $11 million. The verdict is only the second of more than 100 Topamax lawsuits currently underway.