What are Actiq and Fentora?
Actiq is a powerful opioid narcotic that is delivered to the bloodstream by a lollipop lozenge. Anesta, a Utah-based corporation, developed Actiq. The company was purchased by Cephalon in 2000. Actiq was approved by the FDA for the limited use of breakthrough pain in cancer patients who were “opioid tolerant.”
Cephalon also purchased Fentora, a new opioid drug, from Cima Labs. The company began marketing Fentora when Actiq became open for generics in the fall of 2006. Fentora, like Actiq, was approved for the very limited use of breakthrough pain in cancer patients. The FDA-approved indication for Fentora was for patients who were being treated around the clock with opioids. Fentora is reportedly three to four times more powerful than Actiq.
What is the danger with Actiq and Fentora?
In 2007, a study by Prime Therapeutics reported Actiq had an “off-label” use of 90 percent. Off-label use refers to the use of a drug for a treatment other than the specific use approved by the FDA. While doctors are permitted to prescribe a drug for “off-label” use, drug companies are not allowed to promote or market a drug for uses other than those specifically approved by the FDA.
Despite concerns raised by many experts, doctors sometimes use opioid narcotics for treatment of migraine / headache pain. From 2001 through at least 2006, Cephalon was alleged to have promoted Actiq for non-cancer patients to use for such maladies as migraines, back pain, and even injuries.
There is no safe dose of Actiq in patients who are not opioid tolerant. Fentanyl, a key ingredient in Actiq, has been linked to fatal respiratory complications. In fact, Actiq was associated with the deaths of 127 people. The FDA reported another 91 incidents of severe side effects.
Within months, it was reported that the “off-label” sales of Fentora were very similar to those of Actiq. By early summer 2007, several deaths were associated with Fentora use. These deaths prompted Cephalon in September of 2007 to send a “Dear Doctor” letter reporting that “Serious Adverse Events, including deaths, have occurred in patients treated with Fentora.” Cephalon then blamed the deaths on improper patient selection, improper dosing, and/or improper product substitution.
The extraordinary “off-label” use of Actiq caused the FDA’s Office of Criminal Investigations and the U.S. Attorney General to undertake an investigation of Cephalon’s marketing practices. The government asserted that Cephalon had trained its sales force to disregard the FDA restrictions in the approved label. Actiq initially had sales in the tens of millions, but as a result of Cephalon’s aggressive marketing, sales rose to over $500 million dollars by 2006.
What can I do?
Our Mass Torts Section is investigating claims where a doctor or hospital prescribed or administered Actiq, Fentora or another opioid narcotic for treatment other than breakthrough pain in cancer patients. In particular, we are looking at cases of respiratory failure and/or death in non-cancer patients.
If you or a loved one has suffered injury from taking either Actiq or Fentora, you may be entitled to compensation. For a free legal consultation, contact us today!