At least three deaths have been associated with the use of the potent pain medication Fentora, and 120 with its predecessor Actiq. Both drugs contain fentanyl as the active ingredient. Fentanyl is 80 times stronger than morphine and is found in various other generic and prescription drugs, including the Duragesic pain patch—which has also been linked to numerous deaths, and is currently facing litigation from plaintiffs across the country.

Medical Malpractice to Blame?
Because Fentora and Actiq are so strong and potentially dangerous, they are only supposed to be prescribed under very strict circumstances and by doctors trained in the administration of pain medications. Both are approved by the Food and Drug Administration for use in patients with cancer, though doctors frequently prescribe the medications for “off-label” uses (i.e., uses not approved by the FDA).

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Doctors are specifically urged against prescribing Fentora:

~ To opioid non-tolerant patients, or those not on round-the-clock opioid treatment
~ For uses not indicated 
~ To treat acute or post-operative pain, or pain stemming from migraines or sports injuries
~ As a substitute for Actiq or other fentanyl drug

Of the three deaths so far associated with Fentora, two involved patients who were given the drug as a headache treatment and neither patient was on round-the-clock opiate therapy.

Doctors who do not properly prescribe medications, especially ones as potentially deadly as Fentora and Actiq, may be held accountable for injuries or deaths suffered as a result. Contact an attorney today if you suspect that you or someone you love is the victim of medical malpractice. 

Drug Maker Liability
Whereas doctors are allowed to prescribe drugs as they deem fit, drug makers are not allowed to market their products for any uses other than those deemed safe by the FDA. Cephalon, the maker of both Actiq and Fentora, has been accused of illegally marketing its drugs. One of three separate investigations cites the company’s illegal promoting of Actiq to neurologists as headache treatment—an off-label use.

According to a November 2007 report in the Wall Street Journal, off-label uses accounted for more than 80 percent of the prescriptions written for Actiq over a 17-month period. In September 2007, a Cephalon spokeswoman said some physicians prescribe Fentora the same way they prescribe Actiq, implying that off-label uses may account for a disproportionately large number of Fentora prescriptions as well.

Dangerous Drugs
Actiq hit the market in 1999, despite its possible role in the deaths of 80 cancer patients during clinical trials. The drug looks benign—it comes in the form of a lozenge on a stick, closely resembling a lollipop. However, two children died when they mistook the potent drug for candy.

Fentora, a faster acting painkiller than Actiq, was launched in October 2006, and less than a year later, nearly 80,000 prescriptions have been written for the drug.

The active ingredient of the drugs, Fentanyl, is classified by the Drug Enforcement Agency as a Schedule II substance, the same classification as methamphetamine and cocaine. The drug is classified as such because of its high potential for abuse and fatal overdose.

Duragesic Pain Patch
Actiq and Fentora are not the only fentanyl-containing drugs to come under scrutiny lately. The Duragesic pain patch has been the subject of an FDA investigation since 2005 when the agency began looking into the deaths of more than 120 patch users.

Despite FDA warnings, prescriptions for Duragesic have continued to climb. More than 4 million prescriptions were written in 2006, a 10 percent increase from the previous year. Like Actiq and Fentora, Duragesic is intended for a specific group of patients who have  built up an opioid tolerance. Unfortunately, it is often prescribed to treat non-chronic pain; for example, post-surgical or headache pain.

Talk to an Attorney
The continued off-label prescribing of these drugs is alarming. Whether doctors are improperly prescribing the drugs, or pharmaceutical companies illegally promoting them, one fact remains the same—people are dying.

If your loved one has died as a result of Actiq, Fentora, Duragesic or other fentanyl-containing product, one of our experienced attorneys can explain your legal rights and help you seek closure for the loss of your loved one. Contact us today to arrange a complimentary consultation.