The U.S. Food and Drug Administration (FDA) recently issued a warning to the public regarding the potential for deadly overdose for patients taking the Fentanyl-based painkiller named Fentora, which is produced by Cephalon Inc.
Cephalon issued warnings to physicians after several deaths occurred due to inappropriate prescription and “off-label” usage for headaches and back pain rather than its approved use as a painkiller for cancer patients who have developed tolerances to other opiate pain killers.
The Food and Drug Administration issued a report stating that several Fentora related deaths have occurred with patients who were prescribed the drug for “off-label” use. It further warned that Fentora should only be given to patients that have developed an opiate tolerance, as others are unable to handle the high amounts of Fentanyl contained in Fentora.
Cephalon Inc., is discussing the possibility of revising the drug’s label with stronger warnings, as the current label indicates doctors should not prescribe the drug for use in treating acute pain, postoperative pain, headaches/migraines or sports injuries.
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