In the past decade, the off-label prescription of the stimulants Provigil® (modafinil) and Nuvigil® (armodafinil) has increased greatly.
The pharmaceutical firm Cephalon developed the non-amphetamine stimulants Provigil and Nuvigil to help adults prone to sleepiness stay alert. The U.S. Food and Drug Administration (FDA) approved Provigil and Nuvigil to treat narcolepsy, sleep apnea, and shift work disorder.
However, many doctors prescribe the drugs to treat various “off label” conditions. An off-label use of a medication occurs when it is prescribed to treat symptoms not approved by the FDA. Patients may have taken Provigil and Nuvigil for the following off-label applications: Multiple Sclerosis, Depression, Chronic Fatigue Syndrome, Attention Deficit Disorder, weight loss, cocaine addiction, and Parkinson’s Disease.
Such off-label prescribing of a drug by physicians is legal. However, patients taking medications to treat conditions without FDA approval face a risk of dosage errors, drug reactions, and unwanted side effects.
Have you suffered serious side effects from Provigil or Nuvigil after a doctor prescribed them to you for an off-label use?
Provigil Off-Label Use Rising
Today, hundreds of thousands of patients take Provigil or Nuvigil for off-label uses without knowing the full, long-term effects of these drugs. A recent JAMA Internal Medicine study indicates that the number of patients taking Provigil grew from 57,768 patients in 2002 to 555,691 patients by 2009. Nearly 90 percent of the patients involved in the study were prescribed Provigil for an off-label use, with one third of those patients taking the drug for symptoms of depression or multiple sclerosis.
In September 2008, Cephalon (now an acquired branch of Teva Pharmaceutical Industries Ltd.) agreed to pay $425 million to settle charges it had illegally promoted several drugs (including Provigil) for off-label uses. Pharmaceutical companies are forbidden from actively marketing their products for off-label applications.
Provigil Side Effects
In the past, Provigil has been linked to severe life-threatening skin rashes, including:
- Toxic Epidermal Necrolysis (TEN)
- Stevens -Johnson Syndrome (SJS)
- Erythema Multiforme (EM)
- Drug rash with Eosinophilia and systemic symptoms (DRESS)
Additionally, Provigil use has also been associated with hallucinations, anxiety, and suicidal thoughts.
Did Provigil or Nuvigil Injure You?
If you or a loved one has been injured by off-label use of Provigil or Nuvigil, contact us today to discuss filing a dangerous drug lawsuit. At Sokolove Law, we strive to bring justice to families unnecessarily harmed by the adverse side effects of medications and treatments. We’ve been fighting for victims’ rights for over 30 years. We know who to talk to, where to find answers, and what steps you need to take.