THURSDAY September 13, 2007 (Foodconsumer.org) -- A painkiller known as Fentora indicated for cancer patients killed four people among whom two patients used the medication for headache, The Associated Press cited the manufacturer as reporting Thursday.

The Food and Drug Administration today warned doctors on its website that improper use of Fentora can lead to serious adverse events, including deaths.

All four deaths resulted from improper patient selection, improper dosing, and/or improper product substitution, the manufacturer Cephalon Inc. says.    The first two deaths occurred in one who intended to use the drug to commit suicide and the other who administered a high dose of Fentora, the AP reported.    None of the four are cancer patients.

The company sent two letters dated September 10 to doctors and healthcare professionals warning them of the potential danger of Fentora if the drug is not used as indicated.     In the letter, Jeffrey M. Dayno, M.D. Vice President in Medical Services of the company gave detailed safety information, instruction on patient selection and dosing information.

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, but much more potent.

Fentanyl is classified as a Schedule II controlled substance with an abuse liability similar to other opioid analgesics, the company says in its letters. The 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.

The company advised doctors to follow dosing instructions carefully and it says in its letters that for unrelieved breakthrough pain (BTP), patients should NOT take more than 2 FENTORA tablets per BTP episode.    And patients MUST wait at least 4 hours before treating another BTP episode with FENTORA.

For more information, visit the FDA website at

http://www.fda.gov/medwatch/safety/2007/safety07.htm#Fentora