Janssen Pharmaceuticals gained Federal Drug Administration (FDA) approval in 1996 for Topamax, a drug used for the treatment of epilepsy. Since then, the company has marketed the drug to doctors, claiming that it can be used to treat other conditions ranging from obesity to mood and anxiety disorders.
What is Topamax?
Topiramate, the active ingredient in Topamax, is an anticonvulsant that helps subdue excessive neuron activity in the brain, which is the cause of seizures in patients with epilepsy. The drug gained FDA approval for the treatment of epilepsy, and for use in treatment of seizures and developmental delay in children who suffer from Lennox-Gastaut syndrome. The FDA later approved drugs consisting of Topiramate for targeted use in overweight and obese patients suffering from issues such as Type 2 Diabetes and high blood pressure.
Though Janssen Pharmaceuticals received FDA approval for a limited number of conditions that can be treated using Topamax, the company continually marketed the drug for use in treating conditions such as eating disorders, bipolar disorder, alcohol dependency, and post-traumatic stress disorder. The company allegedly provided substantial compensation to doctors who marketed Topamax to patients with these off-label conditions. In 2010, Janssen Pharmaceuticals faced allegations that it illegally marketed the drug, and endorsed Topamax for uses that it had not been federally approved. The allegations went as far to insinuate that the company caused the submission of misleading and false claims to government health programs in order to sell the drug in a larger market. Janssen settled with the Department of Justice for a sum exceeding $70 million dollars.
Damaging Side Effects
The medication yields a number of side effects ranging from mild to highly severe. The milder side effects include unsteadiness, drowsiness, issues with concentration, and blurred vision. However recent studies have influenced the FDA to issue mandates for Topamax and other drugs containing Topiramate, alerting consumers of the risks of the following:
- Metabolic acidosis
- Oligohydrosis, which can lead to heat stroke
- Myopia and secondary closure glaucoma
- Suicidal thoughts and tendencies
- Birth defects such as cleft palate
Topamax has been downgraded to a pregnancy class D drug due to substantial data which revealed adverse reactions to the drug during pregnancy and that there was a considerable physical risk to the fetus.
Current Lawsuits and Consumer Options
Topamax manufacturers are now being confronted with lawsuits of similar allegations to those in 2010. Attorneys claim that Janssen Pharmaceuticals did not adequately advise users and the public of the risk of harm in taking the medication. The company is also facing claims of fraud, negligence, and misrepresentation of the drug. A number of the new plaintiffs are women who were pregnant while taking the drug and were not sufficiently warned of the risks to their unborn children.
If you have been prescribed Topamax for an off label use, or have taken the medication as an anticonvulsant and found yourself experiencing any dangerous side effects, you may be eligible to pursue legal action against the manufacturer. Additionally, if you were pregnant while taking the drug, and your child was born with a physical birth defect such as cleft palate, you should consult with an attorney. Plaintiffs filing suit are seeking compensation for medical costs, pain and suffering, and lost wages, as well as punitive damages to deter Janssen Pharmaceuticals from engaging in this kind of misconduct in the future. If you believe that you or a loved one have been affected, contact The Law Offices of Peter G. Angelos, P.C. for a no-charge consultation.