Nuvigil, a drug that currently is FDA approved to treat fatigue related to shift work and narcolepsy, carries severe warnings that it could cause Stevens-Johnson syndrome.
The FDA will not approve the drug for treatment of jet lag due to what the regulator considers as insufficient evidence in support of using the drug in that manner. Nuvigil is made by Cephalon; the company has ended its campaign to get the drug approved for treating jet lag.
“[T]he company believes that further communications with the FDA will not result in an approval of this application,” Dr. Lesley Russel, Cephalon’s chief medical officer, states. “As a result, the company is no longer pursuing this indication.”
While the most current information about the side effects of using Nuvigil include nausea, headache and insomnia, there also are severe warnings about the chances of patients contracting Stevens-Johnson syndrome and Toxic Epidermal Necrolysis. The warnings for Nuvigil vary and are in depth. Aside from Stevens-Johnson syndrome, users also are warned about the chances of the potential to become addicted to it. Other serious side effects include psychosis, angioedema, anaphylaxis, suicidal thoughts, rash and mania.
If you have taken Nuvigil to treat your jet lag and are suffering from any of these severe side effects, you should contact your doctor immediately. In addition, since using Nuvigil for treating jet lag is considered an off-label use (unapproved by FDA), patients that develop Stevens-Johnson syndrome or Toxic Epidermal Necrolysis after being prescribed Nuvigil to treat their jet lag may be eligible for compensation.
If you or someone you love have suffered from Nuvigil-related Stevens-Johnson syndrome, contact Greg Jones for a free consultation. I am an experienced Stevens-Johnson attorney who will fight hard to get you every dime that you may be entitled to. Contact me today and let me work hard for you.