Cephalon sends Dear Doctor letter warning of Provigil dangers

Prescription medicine may cause Stevens-Johnson Syndrome

10/28/07

On September 21, 2007, Cephalon sent a letter to healthcare professionals, alerting them to life-threatening dangers associated with Cephalon’s drug Provigil. Known generically as modafinil, Provigil is a drug designed to improve wakefulness in patients with sleep-deprivation illnesses. According to the letter, Provigil may cause serious skin and other hypersensitivity reactions, such as Stevens-Johnsons Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN).

The letter instructed physicians specifically that:

  • They should instruct patients who experience allergic reactions to discontinue use and contact their physician immediately;
  • Provigil is not approved for use in pediatric patients; and
  • Provigil can cause psychiatric symptoms.

Source: Cephalon letter to physicians, September 21, 2007.

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