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Provigil Side Effects Could Result In Stevens-Johnson Syndrome Lawsuits

Provigil | Lawsuits, Lawyers | Side Effects: Stevens-Johnson Syndrome, SJS, Toxic Epidermal Necrolysis, Skin Rash

In October 2007, the label of Provigil was updated to include warnings regarding the occurrence of serious rashes, including Stevens-Johnson Syndrome (SJS), hypersensitivity reactions, and psychiatric symptom associated with its use.  According to the Food & Drug Administration (FDA) rare cases of serious or life-threatening rash, including Toxic Epidermal Necrolysis, and Drug Rash with Eosinophilia and Systemic Symptoms have been reported in adults and children in worldwide. Angioedema and multi-organ hypersensitivity reactions were also associated with Provigil.

Provigil was approved by the FDA in 1998 to treat the excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder.  Provigil is sometimes given as a performance enhancement by the military for pilots and soldiers in combat situations. Provigil enhances short-term memory and lets users stay awake for extended periods.  Provigil was never approved to treat pediatric patients.

Provigil Associated with Life-Threatening Skin Rashes

According to the FDA, Cephalon, Inc, the manufacturer of Provigil, agreed to update the drug’s label to include warnings that Provigil had been associated with life-threatening skin rashes, including:

  • Stevens-Johnson Syndrome, a severe and life-threatening condition. Though not well understood, Stevens-Johnson Syndrome is thought to be a hypersensitivity complex affecting the skin and the mucous membrane.
  • Toxic Epidermal Necrolysis, another life-threatening, and usually drug-induced, dermatological condition. It is characterized by the detachment of the top layer of skin from the lower layers of the skin all over the body.
  • Drug Rash with Eosinophilia and Systemic Symptoms, a severe, unexpected reaction to a drug, which affects several organ systems at the same time. It most commonly causes the combination of a high fever, a skin rash and inflammation of one or more internal organs including the liver, kidneys, lungs and/or heart.
  • Angioedema,  the rapid swelling  of the skin, mucosa and submucosal tissues

The new Provigil warnings advised that patients should discontinue use of the drug at the first sign of any skin rash.   It also said that patients should stop using Provigil if they experienced swelling of the face, eyes, lips, tongue, larynx or experience difficulty swallowing or breathing, or suffer from hoarseness.

Provigil and Psychiatric Symptoms

In October 2007, the Provigil label was also updated to include information on psychiatric symptoms associated with its use.  Psychiatric problems, including anxiety, mania, hallucinations, and suicidal thoughts have been reported in patients using Provigil.  The new label warnings advised that cautione should be used in prescribing Provigil to patients with a history of psychiatric problems like psychosis, depression or mania.  The new warnings also said that patients should cease taking Provigil immediately if they develop any of these psychiatric symptoms.

Provigil Side Effects SJS Lawsuit Attorneys

If you or a loved one has been injured by Provigil side effects, you may have valuable legal rights.  Please fill out the form at the right for a free case review by a qualified defective drugs lawsuit attorney or call us at 1-800-YOURLAWYER (1-800-968-7529).


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Chantix Among Drugs Being Reviewed by FDA

Jun 5, 2009 | Parker Waichman LLP
The anti-smoking drug Chantix is among 20 medications currently undergoing a  Food & Drug Administration (FDA) safety review.  According to Reuters, Chantix was included on a list of such  drugs released by the FDA yesterday. Other drugs on the list include Provigil, which is used to treat sleep disorders; the weight-loss drug orlistat; and Detrol, a drug used to treat overactive bladder.research  that have been reported, Reuters said. It should be of no surprise to...

Study: Provigil Might Be Addictive

Mar 19, 2009 | Parker Waichman LLP
Narcolepsy drug Provigil has been found to have potential links to addiction, according to recent U.S. study conducted by drug abuse experts, Reuter’s reports.Cephalon Inc.’s Provigil—generically known as modafinil and approved since 1999—is being used with increased frequency to enhance brain performance, said Reuters, but the narcolepsy drug can be addictive in some people using the drug for this off-label purpose.  The study, conducted as a pilot on 10 healthy...

Cephalon to Pay $425 Million to Settle Illegal Marketing Charges Involving Actiq, Provigil and Gabitril

Sep 30, 2008 | Parker Waichman LLP
Cephalon Inc. has reached a settlement with federal prosecutors over charges that the drug maker illegally marketed its narcotic painkiller Actiq, as well as two other drugs, Provigil and Gabitril.  In addition to paying a fine of $425 million, Cephalon will plead guilty to a criminal misdemeanor for the illegal off-label marketing of its drug.Actiq, sold as a lozenge on a stick, has been implicated in over 120 fatalities, including the deaths of two children who thought the drug was...

Provigil Needs Stronger Warning Against Use In Children, FDA Panel Says

Nov 29, 2007 | Parker Waichman LLP
Provigil, a drug used to treat excessive sleepiness, should bear a stronger warning on its label that the medication is not approved for use in children under the age of 16, a Food & Drug Administration (FDA) panel said yesterday.  While Provigil, manufactured by Cephalon, is not approved for use in children, it has been prescribed to treat a variety of conditions in kids quite frequently. Approved by the FDA in 1998, Provigil has been used to treat the excessive sleepiness associated...

Provigil Warnings Added For Serious Skin Rashes, Psychiatric Problems

Oct 25, 2007 | Parker Waichman LLP
The Provigil label has been updated to include warnings about life-threatening skin rashes and psychiatric problems linked to the drug.  The Food & Drug Administration (FDA) asked Cephalon, Inc., the maker of Provigil, to add the warnings after it had received multiple reports of skin rashes, including a disorder called Stevens-Johnson Syndrome, and psychiatric symptoms occurring in people who took Provigil, including children. Approved by the FDA in 1998, Provigil has been used to...

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