Cephalon has sent health care providers letters about the serious side effects and deaths occurring in patients treated with Fentora. The deaths, which killed four people among whom two patients used the medication for headache, were caused by either improper patient selection or dosing, or even improper substitution of the drug for another drug. None of the four were cancer patients.
Yet, the letters from the biotechnology company have not revealed how many deaths had occurred.
The company has advised doctors to avoid prescribing the drug to those who cannot tolerate opioid therapy and also not to use it as a substitute for its other pain drug, Actiq.
Fentora was approved by the FDA in September for use only by cancer patients who have already taken morphine or other prescription narcotics for their pain. The active ingredient in Fentora, fentanyl, is similar to morphone, yet much more potent.
Fentanyl is classified as a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. Similar medications include morphine, oxycodone, hydromorphone, oxymorphone and methadone, all having the highest potential for abuse and risk of fatal overdose due to respiratory depression.
Cephalon warned doctors not to give Fentora to patients who are opioid non-tolerant or suffer acute pain, postoperative pain, headache, migraine, or sports injuries, even if they are suitable for receiving other opioids on an as needed basis. Doctors are advised also not to substitute Fentora on a one-for-one basis for another, older fentanyl drug called Actiq, which is much weaker than Fentora.