Topamax is used to treat epilepsy. Epilepsy is a chronic brain disorder that causes uncontrollable seizures. Topamax is also used to treat children two years of age, and older, who suffer seizures from Lennox-Gastaut syndrome. Lennox-Gastaut syndrome is characterized by epilepsy and developmental delay. It typically develops when a child is between the ages of two and six.
Topamax received approval from the U.S. Food and Drug Administration (FDA) in 1996. In 2004, Topamax gained extended FDA approval for use in treating migraines. The manufacturer is Janssen Pharmaceuticals, a Johnson & Johnson subsidiary. While Topamax helped many patients, it has also caused dangerous side effects such as metabolic acidosis and birth defects.
What Is Topamax?
The active ingredient in Topamax is an anticonvulsant called topiramate. Topamax helps to suppress the excessive and rapid brain neuron activity that causes epileptic seizures. In 2012, topiramate received FDA approval to be taken for weight loss in combination with phentermine.
The FDA-approval topiramate weight loss drug is called Qsymia. It is prescribed for obese and overweight patients who also suffer an additional weight-related issue. These weight-related issues include type 2 diabetes and high blood pressure.
Topamax Marketing Controversy
While Topamax has only been FDA-approved for epilepsy conditions and migraines, the drug has been prescribed for many other uses. Topamax has been prescribed to treat conditions such as alcohol dependency, bipolar disorder, drug addiction, and post-traumatic stress disorder. It comes in a sprinkle capsule and tablet form.
In 2010, former Topamax manufacturers Ortho-McNeil-Janssen Pharmaceuticals and Ortho-McNeil Pharmaceuticals entered a plea agreement with the Department of Justice. The companies agreed to pay $81.5 million in fines for illegal promotion, branding, and marketing of Topamax. This sum was distributed amongst the federal government, state Medicaid programs, and three whistleblowers.
Topamax misconduct by the manufacturer included:
- Promoting the drug for several off-label and unapproved uses
- Illegally marketing and misbranding Topamax
- Causing the submission of false claims about Topamax to government health programs
Topamax Side Effects
As with many other prescription drugs, Topamax features side effects that range from mild to severe. A common side effect is a change in food and beverage taste. Many users have reported that carbonated beverages such as beer and soft drinks taste particularly bad.
Mild Topamax side effects include:
- Blurred or double vision
- Unsteadiness or clumsiness
- Dizziness or drowsiness
- Trouble with thinking and concentration
Post-market studies have revealed several more serious side effects associated with using Topamax and other drugs containing topiramate. In response to this developing evidence, the FDA has issued a series of mandates for these drugs. While Topamax and other topiramate drugs had a pregnancy category of C, they were downgraded to D. This is because evidence arose of the drugs causing oral birth defects such as cleft palate.
FDA warnings for topiramate warn users of the risk of:
- Metabolic acidosis, or an increase in blood acidity
- Oligohydrosis, or decreased sweating which can lead to heat stroke
- Hyperthermia, or increased body temperature associated with oligohydrosis
- Dangerous eye disorders such as secondary closure glaucoma and acute myopia
- Increased suicidal thoughts and tendencies
- Oral birth defects such as cleft palate when using topiramate during pregnancy
Topamax is facing a number of lawsuits from Topamax users who have been harmed from using the drug. These lawsuits allege that Janssen Pharmaceuticals failed to adequately warn users of the danger caused by Topamax. Additionally, Janssen is being accused of negligence, misrepresentation, fraud, and breach of warranties.
Many plaintiffs are females who took Topamax during pregnancy, which resulted in cleft lip in their children. Plaintiffs are seeking compensatory damages to cover the costs of medical bills, lost wages, pain and suffering, and other costs associated with Topamax side effects. Additionally, many plaintiffs seek punitive damages to deter Janssen from continuing their public misconduct.