Thousands of patients suffer from migraine/headache pain. Despite concerns raised by many experts, physicians sometimes use opioids for the treatment of such pain. Given the strength of many of these drugs and the potential risk of improper patient selection, improper dosing, and misuse, certain patients may be placed at risk from these drugs. A number of concerns have also been raised about subtle or sometimes not so subtle acts by pharmaceutical companies encouraging these drugs for uses not specifically approved by the FDA.
Actiq® is a powerful prescription opioid that is delivered to the bloodstream by a lollipop lozenge. A Utah corporation, Anesta, developed Actiq®. Anesta was purchased by Cephalon in 2000. Actiq® initially had sales in the tens of millions, but as a result of Cephalon’s aggressive marketing, 2006 sales were over $500 million dollars.
Actiq® was approved by the FDA for the very limited purpose of treating breakthrough pain in cancer patients who were “opioid-tolerant.” Breakthrough Pain (BTP), a component of chronic pain, is a transitory flare of moderate-to-severe pain in patients with otherwise stable persistent pain. Patients considered opioid-tolerant are those who are taking at least 60 mg of oral morphine/day, at least 25 mcg of transdermal fentanyl/hr, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid for a week or longer.
However, in 2007, a study by Prime Therapeutics reported Actiq® had an “off-label use of 90 percent. Off-label refers to the use of a drug for 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.
There is no safe dose of Actiq® in patients that are not opioid-tolerant. Fentanyl, a key ingredient in Actiq, has been linked to fatal respiratory complications in those patients. In fact, Actiq® was associated with the deaths of 127 people and another 91 FDA reported incidents of severe side effects.
The extraordinary “off-label” use of Actiq caused the FDA’s Office of Criminal Investigations and the United States Attorney General to undertake an investigation of Cephalon’s marketing practices. The government alleged that from 2001 through at least 2006 Cephalon promoted Actiq® for non-cancer patients to use for such maladies as migraines, back pain, and even injuries. The government investigation also found that Cephalon focused marketing efforts on physicians other than oncologists and structured its sales quotas and bonuses in such a way that sales representatives could only reach their goals if they sold the drug for off-label use. Cephalon ultimately plead guilty to a felony misdemeanor for the Distribution of Misbranded Drugs and paid a fine of $425 million dollars.
By the early summer of 2007, several deaths had been associated with the use of Fentora. However, it was not until September of 2007 that Cephalon sent a Dear Doctor letter.
Cephalon purchased a new opioid drug, Fentora®, from Cima labs which it began marketing when Actiq® became generic in the fall of 2006. Fentora® again had a restricted approved use for breakthrough pain in cancer patients on around-the-clock opioids and was reportedly three to four times as powerful as Actiq®. Within months it was reported that the “off-label” sales of Fentora® were very similar to that of Actiq®. By early summer of 2007, several deaths had been associated with the use of Fentora®. However, it was not until September of 2007 that Cephalon sent a Dear Dr. letter reporting that “Serious adverse events, including deaths, have occurred in patients treated with Fentora®.” Cephalon blamed the deaths on improper patient selection, improper dosing, and/or improper product substitution.
- Fentanyl Buccal (Transmucosal)
- Medication Guide
We are investigating claims in which a doctor or hospital prescribed or administered Actiq® or Fentora® for conditions other than breakthrough cancer pain or another opioid narcotic in a manner that did not meet certain specified safety standards. If you or a loved one has suffered injury from taking a prescription opioid, or if you need additional information, please feel free to contact one of the lawyers at Goza & Honnold, LLC.
Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. Our firm does not intend, by this website or otherwise, to dissuade anyone from taking medication prescribed by their physician, nor is it to suggest someone take a medication without their doctor’s approval. Please consult your doctor, not your lawyer, on matters relating to your health. Patients should talk to their physicians to decide whether they are at risk with Fentora®, Actiq®, or Fentanyl Transdermal Patches or other opioids.
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