The Food and Drug Administration issued a warning today about the risk of potentially fatal overdoses with Fentora, a narcotic painkiller manufactured by Cephalon. The action comes less than two weeks after the company sent a letter to doctors notifying them of three drug-related deaths.
The FDA has received reports of death and life-threatening side effects in patients who have taken Fentora. The reported deaths were the result of improper selection of patients, dosing, or improper product substitution, according to the FDA. One of the deaths was a suicide.
Last October, the FDA approved Fentora for use in cancer patients who experience intense bursts of pain. However, the drug is also sometimes prescribed to treat migraines and short-term pain in non-cancer patients.
According to the government warning, using Fentora for off-label, or non-approved, purposes could lead to deadly overdose, particularly in patients who are not taking narcotic painkillers on a regular basis. All three reported deaths were in patients taking Fentora for off-label uses. Two of the patients were taking the drug to treat migraine headaches.
Fentora is a strong narcotic painkiller that should only be used for treating breakthrough pain in cancer patients who are opioid-tolerant, meaning they take narcotic pain medicines around the clock. Opioid medicines include morphine (Kadian, MS Contin, Oramorph, and others), oxycodone (Oxycontin), and hydromorphone (Dilaudid).
The FDA stresses the following safety information for Fentora: Fentora should not be used to treat any type of short-term pain including headaches, migraines, postoperative pain, or pain due to injury. Fentora should not be used by patients who only take narcotic pain medications occasionally. Health care professionals must not directly substitute Fentora for other fentanyl medicines, including Actiq. Doctors must select the Fentora dose carefully for each patient. Patients taking Fentora and their caregivers must understand how to use Fentora safely and follow the directions in the drug’s Medication Guide exactly.
Health care professionals who prescribe Fentora and patients who use Fentora (and their caregivers) should be aware of the signs of fentanyl overdose. Signs of fentanyl overdose include trouble breathing or shallow breathing; tiredness, extreme sleepiness, or sedation; inability to think, talk, or walk normally; and feeling faint, dizzy, or confused. If these signs occur, patients or their caregivers should get medical attention right away.
Fentora and its predecessor, Actiq, are approved by the Food and Drug Administration only for use in cancer patients, but they are often prescribed by physicians “off-label” for such ailments as headaches and back pain.
Fentora and Actiq contain fentanyl, a highly addictive substance 80 times as potent as morphine. Fentanyl is classified as a Schedule II substance by the Drug Enforcement Administration, which puts it in the same category as cocaine and methamphetamine. Schedule II drugs have the highest potential for abuse and an associated risk of fatal overdose.
Actiq has been associated with more than 120 deaths.
Cephalon, the maker of both Fentora and Actiq, has been accused of marketing its drugs for uses not approved by the FDA and is currently the target of state and federal investigations. The company has denied the allegations.
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