Topamax, also known by its generic name topiramate, belongs to a class of medications called anticonvulsants. Manufactured initially by Ortho-McNeil Neurologics and Noramco, Inc., divisions of Johnson & Johnson, Topamax is an oral medication dispensed in both tablet and sprinkle form (medication is sprinkled on food and ingested).
Approved by the U.S. Food and Drug Administration (FDA) in December 1996, Topamax is prescribed to epileptics to treat certain types of seizures, to those with Lennox-Gastant Syndrome, and to those suffering with migraines as preventative medicine. The generic brand topiramate was approved in April 2009. While indicated for use alone or in conjunction with other drugs, studies show that this medication’s greatest success comes when it is used as an add-on medication, not as sole therapy. Some common side effects include paresthesias (numbness or tingling in the arms and legs), fatigue, loss of appetite, nausea, difficulty with concentration, and vision problems.
Illegal Marketing and Promoting
In April 2010, two of Johnson & Johnson’s subsidiaries agreed to pay over $81 million to resolve allegations regarding the illegal promotion and marketing of Topamax. According to a Department of Justice press release, these subsidiaries promoted “Doctor-for-a-Day” programs that hired outside physicians to join sales calls and to speak at meetings encouraging doctors to prescribe Topamax for “off-label” uses. As a result, doctors with psychiatric patients prescribed Topamax to treat Bipolar Disorder, eating disorders, alcoholism, and post-traumatic stress disorder (PTSD)—all unapproved indications. Ortho-McNeil-Janssen Pharmaceutical Inc., (OMJP) paid over $75 million to the government to resolve civil allegations under the False Claims Act, cases involving fraud against federal health care programs. The government maintained that OMJP “illegally promoted Topamax and caused false claims to be submitted to government health care programs for a variety of psychiatric uses that were not medically accepted indications.”
Topamax and its generic brands have also been proven to cause serious and life-altering side effects to users of Topamax and their unborn children. Studies show that children born to women taking Topamax in the first trimester of pregnancy have a higher rate of developing oral clefts: cleft lips and/or cleft palates. These birth defects occur when parts of the lip or palate do not fuse together in utero. Defects can range from a small notch in the lip to a groove that runs through the top of the mouth to the nose. Children with oral clefts have problems eating, talking, and/or reoccurring ear infections. Clefts cause noticeable facial flaws and most sufferers must endure surgery in order to correct the defect. In 2010, a group of researchers from Harvard, Loyola, and Mass General in conjunction with the North American Antiepileptic Drug (AED) Pregnancy Registry, a registry used to collect data regarding the effects of new drugs on pregnant women using antiepileptic drugs, published a study of 6,456 pregnant women. The study found children born to women using Topamax or topiramate in the first trimester of pregnancy were “associated with a higher risk of major malformations and low birth weight.” After receiving and reviewing this data from the AED, the FDA issued a health alert on March 2, 2011 to healthcare professionals and patients. The drug was moved from a Category C drug to a Category D drug, one that has proven evidence of human fetal risk based on human data.
Have You Been Affected by Topamax?
Any individual or the relative of an individual who has suffered due to Topamax’s side effects is permitted to file a lawsuit. You may be eligible to seek reimbursement for medical expenses, compensation for pain and suffering, and punitive damages (compensation granted for losses suffered).
Different states have different legislation regarding medical lawsuits, so it is essential to hire an experienced and effective lawyer who can file the case. We can match your case with attorneys who have the experience to handle even the most complex claims and is accepting new cases. If you need further information about the harmful side effects of Topamax or legal advice concerning personal injury matters, you are invited to contact us or fill out the form on this website for a free case evaluation.