Topamax is approved to treat epilepsy and prevent migraines. It can cause cleft lip and palate birth defects when taken by pregnant women.
Topamax is the brand name for the anticonvulsant drug topiramate, manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. Topiramate was approved by the Food and Drug Administration (FDA) in 1996 for use in the treatment of epilepsy, a neurological disorder characterized by recurrent, uncontrolled seizures. It is also prescribed for patients two years or older whose seizures are associated with Lennox-Gastaut syndrome, a disorder that accounts for up to 10 percent of all cases of childhood epilepsy.
In 2004, the FDA approved Topamax for the treatment of migraine headaches. While the medication does not relieve the pain of a migraine after it starts, it is believed to reduce migraine frequency by widening the blood vessels in the brain that can become constricted.
In July 2012, the FDA approved the drug Qsymia – which contains topiramate and phentermine – after a 2011 study revealed noticeable weight loss success in 3,300 patients who took topiramate. Phentermine is an appetite suppressant. A year earlier, the same drug — then called Qnexa — was rejected by the FDA because of the adverse side effects of its topiramate component. However, a federal advisory panel has reconsidered Qnexa and sent its recommendation for approval to the U.S. Food and Drug Administration. The FDA label warns Qsymia may cause mood and sleep disorders, cognitive impairment and increased heart rate. It could also lead to suicidal thoughts, and people who suddenly stop taking it can suffer seizures.
Qsymia is only prescribed for overweight and obese people who have at least one weight-related health problem, such as high blood pressure or type 2 diabetes. It must also be used in coordination with diet and exercise. However, it is not recommended for people only looking to lose a few pounds because people who stop taking the drug often gain the weight back.
From 2007 to 2010, 4.3 million people filled 32.4 million topiramate prescriptions in the United States. Generic versions of topiramate have been available since 2006.
Topiramate has been prescribed for several unapproved, or off-label, applications, including the treatment of bipolar disorder, alcohol dependency, cocaine and methamphetamine addiction, obsessive-compulsive disorder, borderline personality disorder, and post-traumatic stress disorder, among others.
In May 2010, under a plea agreement with the U.S. Department of Justice (DOJ), Ortho-McNeil Pharmaceuticals and Ortho-McNeil-Janssen Pharmaceuticals agreed to pay fines of $81.5 million for promoting Topamax for off-label uses, misbranding and illegally marketing the drug, and causing false claims about it to be submitted to government health programs. Under the agreement, the federal government received $50.69 million, state Medicaid programs shared $24.68 million, and three whistleblowers received the rest.
FDA Warnings and Pregnancy Complications
Topamax has a number of common side effects, which its manufacturer claims to be “mild to moderate.” However, over the years, post-market studies revealed several much more serious health risks associated with the drug.
|In response, the FDA has continually mandated that all topiramate labels and medication guides contain updated warnings and precautions associated with its use.|
|In 2004, the FDA required a warning about Topamax’s risks for metabolic acidosis (an increase in the level of acid in the blood); oligohydrosis (decreased sweating); and hyperthermia (increased body temperature).|
|In 2006 The FDA required a warning about serious eye disorders, such as acute myopia and secondary angle closure glaucoma.|
|In 2008, the FDA began providing doctors a review of 200 medical studies indicating that Topamax caused an increase in suicidal thoughts and actions. The drug’s warning label was modified to include such language.|
|In 2011, the FDA informed the public of new data showing that there is an increased risk for the development of cleft lip and/or cleft palate in infants born to women treated with topiramate during pregnancy. It required a warning about the risks of oral birth defects, and downgraded Topamax’s classification from pregnancy category “C” to “D” which means there is evidence of fetal risk among humans.|
Topamax state and federal lawsuits are growing. In Pennsylvania, for example, dozens of filings against Janssen Pharmaceuticals have been centralized in the Philadelphia Court of Common Pleas’ Complex Litigation Center, the first courthouse in the U.S. designed exclusively for complex, multi-filed Mass Tort cases.
The company is accused of failure to warn, negligence, fraud, misrepresentation, and breach of express and implied warranties. Plaintiffs are seeking compensatory and punitive damages for children born with oral cleft birth defects after their mothers took Topamax while pregnant.