Actiq fentanyl lollipop may be deadly when used by non-cancer patients

by Jim Orr

Actiq is a “lollipop” form of the powerful opiod fentanyl. A patient sucks on the lollipop to obtain pain relief. Actiq is approved for breakthrough pain in cancer patients who have developed a tolerance to other opioid drugs. This mode of administration is critical for cancer patients who suffer nausea and cannot swallow or keep anything down.

Actiq is approved for only a specific use by a specific group of patients: “for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.”

The prescribing information provided by the manufacturer warns that Actiq is not for patients who are not already “opioid tolerant” and is not for management of acute or postoperative pain, including headache or migraines because of “the risk of fatal respiratory depression.” The manufacturer warns that:

Fatal respiratory depression has occurred in patients treated with ACTIQ, including following use in opioid non-tolerant patients and improper dosing. The substitution of ACTIQ for any other fentanyl product may result in fatal overdose.

Due to the risk of respiratory depression, ACTIQ is contraindicated in the management of acute or postoperative pain including headache/migraine and in opioid non-tolerant patients.

Furthermore, because substantial differences exist in the pharmacokinetic profile of ACTIQ compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl that could result in fatal overdose, the manufacturer warns that prescribing doctors should not convert patients on a mcg per mcg basis from any other fentanyl products to ACTIQ. And should not substitute an ACTIQ prescription for other fentanyl products.

The Actiq lollipop is a very powerful narcotic, which is extremely addictive. Given the increased risk of overdose and death, the FDA only approved use of the drug for cancer patients who were unable to relieve severe pain with other medications.

Actiq off-label uses have included treatment of chronic back pain, knee injuries and severe headaches. Estimates have indicated that over 80% of Actiq users do not have cancer. As a result of this widespread use of the narcotic, many users have suffered a fatal overdose which could have been prevented if a different pain medication had been used.

Cephalon, the manufacturer of the Actiq lollipop, has in the past been accused of heavily promoting the pain killer for uses which have not been approved by the FDA.

In 2007, Cephalon paid $425 million to the Department of Justice in a settlement for illegal promotion of Actiq. That deal highlighted the business side of off-label sales: 80 percent of Actiq’s sales were off-label and the company was promoting it as “an ER on a stick.”

Although drug manufacturers are prohibited by federal regulations from actively promoting non-approved uses or encouraging doctors to prescribe a medication for “off-label” uses, sales representatives have marketed the lollipop pain killer to all types of doctors, not just oncologists. Accusations have been raised that the pain killer was promoted to doctors such as general practitioners and sports injury doctors, even if they were not likely to treat severe cancer-related pain.

Actiq lollipop has been associated with the deaths of at least 127 people. Unfortunately, Actiq continues to be prescribed off-label for non-cancer related pain. For example, in 2010, a Kansas doctor was accused of unlawfully prescribing Actiq, leading to the fatal overdoses of fifty-six patients. In addition to the 56 deaths, the doctor’s practice allegedly sent 94 patients to the emergency room with overdoses; all other doctors in the area sent fewer than five each.

If your loved one was recklessly prescribed the Actiq lollipop, you probably have many questions and you are entitled to answers.

The lawyers at Heygood, Orr & Pearson are among the nation’s leaders in handling cases involving potent opioids, and our law firm has the experience to prosecute medical malpractice cases involving a wide array of serious opioid painkillers, including Vicodin and Hydrocodone, OxyContin and Oxycodone, Methadone, Hydromorphone, Fentanyl, and others.

If you or a loved one has experienced the tragedy of losing a family member because of a prescribing error, you have the right to demand that the responsible healthcare provider be held accountable. Contact us for a free consultation so we can help you determine the best way to protect your legal rights and interests.

To receive a free legal consultation and find out if you are eligible to file a case, please call our toll-free number at 1-877-446-9001, or by filling out our free case evaluation form located on this page.

by Jim Orr

Jim Orr is a licensed attorney and a partner at HO&P focusing on business and personal injury litigation. Jim was selected multiple times to the Super Lawyers List and has tried 70+ cases to verdict.