Thousands of persons suffer from debilitating migraine/headache pain. Despite concerns raised by many experts, doctors sometimes use opioid narcotics for treatment of such pain. Given the strength of many of these drugs and the potential risk of improper patient selection, improper dosing, and mis-use, certain patients may be placed at risk from these drugs. Despite these safety risks, drug companies are encouraging doctors to prescribe these drugs for purposes not specifically approved by the FDA.
One such drug, Actiq, is a powerful opioid narcotic that is delivered to the bloodstream by a lollipop lozenge. Cephalon has owned and marketed Actiq since 2000. Due to Cephalon’s aggressive marketing, annual sales for Actiq have exceeded $500 million dollars. Actiq was approved by the FDA for the limited use of 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 per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least eight mg of oral hydromorphone daily, or an equianalgesic dose of another opioid for a week or longer.
In 2007, a study by Prime Therapeutics reported Actiq had an “off-label” use of 90%. There is no safe “off label” use of Actiq. The drug is highly dangerous for persons 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 and another 91 FDA reported incidents of severe side effects.
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. The extraordinary “off-label” use of Actiq prompted the FDA’s Office of Criminal Investigations and the U.S. Attorney General to undertake an investigation of Cephalon’s marketing practices. 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. The government asserted that Cephalon had trained its sales force to disregard the FDA restrictions in the approved label.
The government’s investigation revealed that Cephalon focused marketing efforts on doctors other than oncologists and that Cephalon 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 pled guilty to a criminal charge for Distribution of Misbranded Drugs and paid a fine of $425 million dollars.
Cephalon purchased Fentora, a new opioid drug, from Cima Labs. The company began marketing Fentora when Actiq became open for sale as a generic during the Fall of 2006. Fentora, like Actiq, is 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.
Within months of being on the market, it was reported that the percentage of Fentora sales associated with “off-label” use was very similar to that of Actiq. By early summer 2007, several deaths were associated with Fentora use. These deaths prompted Cephalon in September 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.
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. If you or a loved one has suffered injury from taking an opioid narcotic or if you need additional information, please contact Leigh O’Dell or Alyce Addision at 1-800-898-2034 or by email at Leigh.Odell@BeasleyAllen.com.
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