Provigil Prescribed for Unapproved Uses
Last Updated on June 26, 2017
Important Information
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At A Glance
- This Alert Affects
- Patients who took Provigil (Modafinil) and developed serious side effects, such as Toxic Epidermal Necrolysis.
- Damages
- Provigil can lead to Stevens-Johnson Syndrome, life-threatening rashes, mental changes and allergic reactions.
- Company(ies)
- Cephalon
- Additional Details
- Provigil (Modafinil) is used to treat sleep disorders including narcolepsy, sleep apnea, hypopnea syndrome and shift work sleep disorder. Provigil may have also been prescribed for off-label uses, such as the treatment of depression, ADD, ADHD and jet lag.
- Date
- In Oct. 2007, Cephalon added a new warning label to Provigil to detail the risk of possible serious skin rashes and psychiatric changes.
Provigil is a medication manufactured and marketed by the drug company Cephalon and used to treat sleeping disorders, such as narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS), and shift work sleep disorder (SWSD). It was approved for use in the United States in 1998. Provigil is only approved or the treatment of sleeping disorders, though it appears to be used extensively for off-label uses, such as the treatment of ADD, ADHD, Depression, Jet-Lag, and other lifestyle uses. Use of Provigil for these purposes was not tested or considered by the Food and Drug Administration (FDA) when the drug was approved. Other effects of the drug include stimulation of the Central Nervous System, resulting in feelings of euphoria, mood swings, and changes in perception, thinking, and feeling.
The FDA and Cephalon updated the warning section on Provigil to include safety information which indicates that there are serious side effects associated with the use of the drug, including:
- Serious rashes and skin irritation, including blisters, hives, swelling of the face, and difficulty breathing and swallowing,
- Associated with allergic reactions.
- Stevens-Johnson Syndrome (SJS)
- Hypersensitivity Reactions, such as Angioedema and other multiorgan reactions
- Life-threatening rashes, resulting in Toxic Epidermal Necrolysis, Eosinophilia, and other serious drug rashes
- Mental and psychiatric reactions resulting in suicidal thoughts and tendencies, anxiety, mania, and hallucinations
Consequently, if you or a loved one taking Provigil experiences side effects similar to these, you should immediately contact your doctor and discuss strategies for discontinuing use of the medication. In the event of damages, patients may be entitled to compensation from the drug manufacturer.
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