Stevens-Johnson Syndrome could result from Provigil side effects
New warnings will be added to the label of Provigil (generic modafinil tablets), indicating that the “wakefulness promoting agent” could lead to the development of Stevens-Johnson Syndrome and other serious side effects. The lawyers at Saiontz & Kirk, P.A. investigate potential lawsuits nationwide for any individuals diagnosed with Stevens-Johnson Syndrome, a painful and potentially fatal skin reaction.
>>INFORMATION: Stevens-Johnson Syndrome Lawsuits
Provigil is an anti-sleep mediction which is manufactured by Cephalon, Inc. The drug has been on the market for over 8 years, and it is approved for treatment of excessive sleepiness and certain sleep disorders, such as narcolepsy, obstructive sleep apnea / hypopnea syndrome (OSAHS) and shift work sleep disorder (SWSD). Although it is not specifically approved for use in children, it is sometimes prescribed off-label for ADD /ADHD. It is also known to be used off-label to suppress the need for sleep or as a doping agent.
Yesterday, Cephalon and the FDA indicated that they are revising the label to update the safety information to include warnings about Provigil side effects which could cause Stevens-Johnson Syndrome (SJS), hypersensitivity reactions and psychiatric symptoms. The FDA also indicates that rare cases of serious or life-threatening rashes, including Toxic Epidermal Necrolysis (TENS) and Drug Rash with Eosinophilia and Systemic Symptoms have been reported in adults and children. Angioedema and multi-organ hypersensitivity reactions have also been reported.
STEVENS-JOHNSON SYNDROME
Stevens-Johnson Syndrome, commonly referred to as SJS, is a serious skin reaction which can occur as a side effect of certain medications. It causes a severe rash and blistering of the skin and mouth, effectively burning the skin from the inside out. It often requires treatment in an intensive care burn unit, and it is fatal in about 5% to 15% of all cases.
Symptoms of Stevens-Johnson Syndrome could include:
- Rashes
- Blisters on the skin, mouth, eyes, ears, nose or genitals
- Red Spots on the Skin
- Swelling of the eyelids
- Fever
The FDA has asked physicians to instruct their patients to stop using Provigil and seek immediate medical attention if a rash or other symptoms occur.
PROVIGIL LAWSUITS
If you, a friend or family member have been diagnosed with Stevens-Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis Syndrome (TENS), as a side effect of Provigil, financial compensation may be available. To review your legal rights and determine if you may qualify for a Provigil lawsuit, request a free consultation and claim evaluation.
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