Fentora lawsuits are reviewed as FDA issues warning
The FDA issued a public health notice yesterday about the risk of death associated with the use of Fentora tablets. Side effects could result in overdose or death caused by inappropriate use and over-prescription. The manufacturer, Cephalon, Inc., has agreed to add stronger warnings and improve the dosing instructions to reduce the risk of problems. The lawyers at Saiontz & Kirk, P.A. are reviewing potential Fentora lawsuits for deaths caused by overdose after using the drug.
>>INFORMATION: Fentora lawsuits
Fentora (fentanyl buccal tablets) is a form of fentanyl, a very potent opioid analgesic. It was approved by the FDA in September 2006 for the limited purpose of treating severe or breakthrough pain in cancer patients. However, as a result of inadequate instructions and warnings provided by the drug maker, Fentora has been prescribed “off-label” to many individuals who do not have cancer and at dangerously high doses.
Earlier this month a letter was sent to health care providers about the risk of Fentora overdose and death, but the FDA public health notice is designed to provide general information to consumers. There have been several reported deaths after using Fentora, and the FDA is closely monitoring the issue. The Fentora advisory warns that the tablets should only be used by those who are on another opioid drug and who have cancer. Many of the Fentora deaths have been linked to inappropriate use, such as for treatment of headaches, migrains or other short-term pain.
Cephalon, Inc., the maker of Fentora, will add stronger warnings to the drugs label about the risk of overdose and death. They will also do a better job of providing accurate dosing instructions.
As a result of the drug maker’s prior failure to provide accurate warnings and dosing information, many doctors were unnaware of the extent of the risks of Fentora side effects. It was not uncommon for doctors to prescribe Fentora at the same dose as Actiq, another fentanyl drug which is delivered in a lollipop form. However, Fentora is much stronger than Actiq and delivers more fentanyl to the blood, which could result in a fatal overdose if prescribed at the same dose.
FENTORA LAWYERS
If a family member or friend died as a result of a Fentora overdose, request a free claim evaluation. The Fentanyl lawyers at Saiontz & Kirk, P.A. are reviewing potential lawsuits throughout the United States. Cases are also being reviewed for overdose and death associated with other Fentanyl products, such as Actiq and the Duragesic Fentanyl Patch.
[...] 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. [...]