Cephalon's Actiq Off-Label Marketing

Send to Friend | Bookmark | Live Chat

Actiq (known generically as oral transmucosal fentanyl citrate (OTFC)), has been commercially sold in the United States since its approval by the US Food and Drug Administration (FDA) in 1999. The FDA approved the drug for use in cancer patients suffering from intense pain which is unrelieved by the use of other narcotics. Manufactured and marketed by Cephalon Inc., Actiq sales generated over $470 million in revenue in the first three quarters of 2005. The medication is classified as a strong narcotic, also containing fentanyl which is classified as a schedule II controlled substance. A standard dose is a white berry-flavored lozenge on a stick, which is swabbed between the cheeks and gums to introduce the drug into the bloodstream, providing quick relief of severe pain.

Update: Our firm is only accepting Actiq overdose cases. If a friend or loved one has suffered from an unfortunate Actiq induced overdose related death, you should contact us immediately. You may be entitled to compensation and we can help.

The only approved use of Actiq is the pain relief of cancer patients suffering breakthrough cancer pain. Other uses have included treatment of patients suffering bone injuries, arthritis, migraines, severe back pain, and other types of moderate to severe chronic pain. Some of the most common side effects include dry mouth, nausea, dizziness, hot flashes, and constipation. The most serious adverse effects noted in this type of drug include shock, circulatory depression, respiratory depression, and hypotension, sometimes resulting in death. The smallest prescribed dosage is enough to kill a child, so extreme care must be taken to keep Actiq away from children.

The primary active ingredient in Actiq is fentanyl, a drug more than 80 times stronger than morphine. This creates an enormous potential for addiction and more often than not kills those who overdose on it. Actiq has become the narcotic of choice among recreational drug users and has gained the nickname “perc-o-pop” in the drug underworld. 127 fatalities have occurred in patients taking Actiq and another 91 serious injuries such as respiratory distress and severe dehydration has been reported to the FDA.

The drug manufacturer, Cephalon Inc., is currently under investigation for illegal practices by the Connecticut attorney general, and has been for the last two years. At issue is the allegation that Cephalon Inc. engaged in unethical and/or questional practices to increase their Actiq sales, including off label marketing. The manufacturer was accused of promoting Actiq to medical specialists other than oncologists, as well as conducting small studies in order to promote Actiq prescriptions for migraine relief. Cephalon has issued a statement saying that the company has cooperated with the investigation and will continue to do so until its completion.

The determination has been made that Actiq has been widely overused, increasing the risks of abuse, addiction, and serious side effects. Studies have found that 90% of prescriptions for Actiq are considered off-label, which means they are written for treatments not approved by the FDA. Only 10% of prescriptions of Actiq are for the original purpose, which is to treat severe pain in cancer patients. Due to questionable promotion and marketing by the drug manufacturer, the medication is commonly prescribed for less serious aliments. This has resulted in a number of users suffering injuries which could have been prevented with a lower-strength medication. Records have shown that the majority of those with Actiq prescriptions have not been diagnosed with cancer or AIDS, and more than 15% of those prescriptions are for higher doses than recommended by the FDA.

Do I have an Actiq Lawsuit?

The Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Actiq lawsuits. We are handling individual litigation nationwide and currently accepting new Actiq cases in all 50 states.

Attention Attorneys: We do not publish prior verdict/settlements. If you are an attorney and would like to refer us a case or for us to send you a profile of prior award judgments or average referral fees, please visit the attorney referral section of our website.

= Required Field