FDA Issues Advisory on Fentora Following Overdoses, Deaths
Fentora, a cancer pain medication, is too frequently misused and improperly prescribed, according to a Public Health Advisory recently issued by the U.S. Food and Drug Administration (FDA). Manufactured by Cephalon, Inc., Fentora is most commonly prescribed to treat breakthrough pain in terminal cancer patients who have already developed a tolerance to opioid pain medications. According to the FDA, Fentora-associated deaths have recently occurred in non-cancer patients, and in patients who lacked opioid tolerance, indicating that the drug has been prescribed incorrectly. Some patients have suffered adverse reactions following a dosage of Fentora that was too high, and some adverse events have occurred after patients took too many doses of the drug.
The agency is reinforcing the following safety information regarding the safe use of the pain medication:
- Fentora should not be used to treat anytype of short-term pain including headaches or migraines, postoperative pain, or pain due to injury.
- Fentora should not be used by patients who only take narcotic pain medications occasionally.
- Healthcare professionals must not directly substitute Fentora for other fentanyl medicines, including Actiq.
- Doctors must select the Fentora dose carefully for each patient.
- Patients who take Fentora and their caregivers must understand how to use it safely and follow the directions exactly. Directions for taking Fentora are provided in the Medication Guide for patients.
- Healthcare 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."
Previously on the D.C. Metro Area Medical Malpractice Law Blog, we have posted articles related to:
- An FDA warning to pregnant women regarding codeine
- A study demonstrating that 80% of pediatric patients receive adult drugs or dosages
- A study illustrating that most Americans take their prescription drugs incorrectly or not at all
If you have questions regarding a medication or medication dosage, you should contact your physician immediately.
If you or a family member believe that you have a case involving a medication or medical care, please contact us on-line at Regan Zambri & Long or call us at 202-463-3030 for a free consultation. If you would like to receive our complimentary electronic newsletter, please click here.