First approved in 1998 for the treatment of epileptic seizures, Topamax, or Topiramate, has now landed itself near the top of many law firms’ hit list. The issue at hand for the Topamax Lawsuit is the connection that has been found between patients prescribed Topamax, and their children being born with a cleft palate.
The History of Topamax
Discovered in 1979 by Bruce Maryanoff and Joseph Gardocki while employed by McNeil Pharmaceuticals, the drug was originally produced by Ortho-McNeil Neurologics and Noramco.
Topamax, marketed as an anticonvulsant, is primarily used to treat epilepsy in adults and children, and was given FDA approval for that purpose. In 2006 the FDA also approved generic versions of Topamax, brining the price down significantly.
The Prescribed Uses of Topamax
Along with it’s use as an anticonvulsant, Topamax has become favored by physicians for other uses. Among it’s uses, Topamax was primarily prescribed for treatment of migraines, and found effective in the treatment of the development delay disorder, Lennox-Gastaut syndrome, which can cause seizures in infants,
Topamax has also been a popular drug for psychiatrist, who prescribe it for a great many uses, including the treatment of bipolar disorder, alcoholism, binge eating for morbidly obese patients, and (PTSD) post-traumatic stress disorder. Along with being used for treatment of infantile spasms, other studies show promising results for Topamax as a treatment for preterm infants to prevent periventricular leukomalacia after a hypoxic-ischemic injury.
Topamax Combating Obsessive Compulsive Disorder
Psychiatrist have been performing studies in using Topamax to combat symptomatic obsessive compulsive disorder, in an attempt to elevate behavior such as bulimia, smoking, and neuropathic pain.
How normally a SSRI (selective serotonin reuptake inhibitors) is prescribed, a recent study in the Journal of Clinical Psychiatry suggests there could be a benefit to adding Topamax to current SSRI treatments.
Another case study shows some promising results for Topamax in the treatment of Kleptomania.
Topamax Side Effects
There are numerous side effects that can lead people to stay away from Topamax. Problems like fatigue, nausea, diarrhea, paresthesia, memory loss, and confusion. One of the most serious side effects is the significant increase in suicide in patients prescribed Topamax.
In addition to the drastic side effects, there are issues with overdosing in Topamax that can cause blurred vision, fainting, agitation, depression heart palpation, etc…
Topamax Legal Issues
The Topamax birth defect lawsuits are not the first legal issue for the drug. In 2010, Ortho-McNeil paid a $6.14 million fine to the FDA after pleading guilty to promoting the Topamax drug for psychiatric treatment without applying for, or receiving an approval from the FDA.
In this latest round of legal issue, a large mass tort initiative has been launched by law firms connecting the use of Topamax by women, and birth defects, specifically a cleft palate, or palatoschisis.
A cleft is the non-fusion, or gap, of an infants natural structure. A cleft palate can be treated through surgery, but is obviously traumatizing on the child.
Labels for Topamax have been updated with new warnings about the increased risk of cleft palate for patients who are either pregnant, or may become pregnant. It’s estimated that the risk of an infant being born with a cleft palate to a mother taking Topamax during her pregnancy is approximately 200% higher, or 1.4% vs. .07%.
It’s likely that this will be a massive lawsuit, and result in the company settling for ten of millions of dollars. Recent pharmaceutical mass tort litigation with cases like Accutane and Wellbutrin have be proven to be extremely costly for pharmaceutical companies, and this will likely be no different.