FDA concerned about Fentora problems with wider use
Cephalon, Inc. is attempting to seek FDA approval for Fentora tablets to be used for sudden pain in non-cancer patients who have already developed a tolerance to opioids. An FDA advisory panel is scheduled to meet on Tuesday to review the subject. Documents released in advance of the meeting indicate that the FDA is concerned that wider approval could have a “devastating effect” due to the risk of Fentora overdose and abuse.
Fentora is a prescription pain medication which contains fentanyl, a very strong and highly addictive narcotic . There have been many reports of Fentora problems caused by the drug being prescribed at the wrong doses or used incorrectly. In addition, the FDA issued an alert in September 2007 regarding the risk of fentanyl overdose deaths linked to off-label use of Fentora.
Cephalon originally designed Fentora as a substitute for their Actiq lollipops, which contain fentanyl in a lozenge on the end of a stick. Both Fentora and Actiq are currently approved for treatment of unmanagable breakthrough pain in cancer patients and they are only to be given to individuals who are already tolerant of opioid drugs. However, both medications are already widely prescribed “off-label” to individuals who do not have cancer.
Once a medication is approved by the FDA for any purpose, doctors are able to prescribe the drug “off-label” for non-approved use. Although drug makers are not supposed promote their medications for unapproved uses, Cephalon has been accused of sending sales representatives to discuss the benefits of Actiq with general practitioners, sports injury doctors and other physicians who were not likely to treat cancer-related pain.
>>PRIOR POST (3/26/2007): Makers of Actiq Lollipop part of Congressional Inquiry
The panel of outside experts convened by the FDA will review whether wider use of Fentora is appropriate. According to Bob Rappaport,from the FDA’s Division of Anesthesia, Analgesia and Rheumatology Products, expanded use of Fentora “may increase the availability of the product for diversion, abuse and misuse.” It may also increase the occurrences of accidental fentanyl toxicity overdose due to the potency of the drug. Although the FDA is not required to follow the recommendations of their advisory panels, they usually do.
OFF-LABEL FENTORA OVERDOSE LAWSUITS
The fentanyl lawyers at Saiontz, Kirk & Miles, P.A. are reviewing potential Fentora overdose lawsuits throughout the United States on behalf of individuals who died after receiving the powerful pain killer to treat non-cancer related pain. Lawsuits are also being investigated for overdoses and deaths associated with other fentanyl products such as the Actiq lollipop and Duragesic fentanyl patch. If a friend or family member has died as a result of fentanyl toxicity after taking Fentora, Actiq or using the Fentanyl Patch, request a free consultation and claim evaluation.
