Topamax treats epilepsy. Epilepsy is a chronic brain disorder that causes uncontrollable seizures. Topamax also treats children two years of age and older who suffer seizures from Lennox-Gastaut syndrome. Lennox-Gastaut syndrome is a syndrome with a patient who has epilepsy and developmental delay. It typically develops when a child is between the ages of two and six.
Is your child suffering injuries? You may be able to file a lawsuit.
Topamax received approval from the U.S. Food and Drug Administration (FDA) in 1996. In 2004, Topamax gained further FDA approval for use in treating migraines. The manufacturer is Janssen Pharmaceuticals, a Johnson & Johnson subsidiary. While Topamax helps many patients, it also causes side effects such as metabolic acidosis and birth defects.
If your child is suffering from birth defects, you should consult with a lawyer about your options. Talking to an attorney can help.
What Is Topamax?
The active ingredient in Topamax is the anticonvulsant topiramate. Topamax helps to suppress excessive and rapid brain activity that causes epileptic seizures. In 2012, topiramate got FDA approval to be taken for weight loss with phentermine.
The FDA-approval topiramate weight loss drug is called Qsymia. Doctors prescribe it for obese and overweight patients who also suffer one other weight-related issue such as type 2 diabetes and high blood pressure.
Topamax Marketing Controversy
The FDA has approved Topamax for epilepsy conditions and migraines, but doctors may also give it to patients for other reasons. Without FDA approval, however, it can be dangerous for patients to take this drug for other uses. This can lead to serious and life-changing side effects.
Topamax is given by doctors for problems 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.
Examples of Topamax misconduct by the manufacturer include:
- Promoting the drug for several off-label and unapproved uses
- Illegally marketing and misbranding Topamax
- Sendingf 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. Your doctor should tell you about the side effects for the drug before you take it, but the manufacturer may not provide all the information you need to make a decision.
A common side effect is a change in food and beverage taste. Many users report that carbonated drinks 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 show several more serious side effects for Topamax and other drugs with topiramate. In response to this new evidence, the FDA has is sharing further information about them. While Topamax and other topiramate drugs had a pregnancy category of C, they were downgraded to D. Since the drug may cause cleft palate or other birth defects, the FDA is still monitoring Topamax.
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 with injuries from using the drug. These lawsuits allege that Janssen Pharmaceuticals failed to adequately warn users of the danger caused by Topamax. Additionally, users accuse Janssen of negligence, fraud, and breach of warranties.
Many plaintiffs are females who took Topamax during pregnancy, which can result in cleft lip in their children. Plaintiffs may seek damages to cover the costs of medical bills, lost wages, pain and suffering, and other costs for Topamax side effects. Additionally, many plaintiffs seek punitive damages to deter Janssen from their public misconduct.