(Prescribing a drug for something other than one of the indications for which the product is approved by the FDA is called off-label prescribing, and it is illegal. And it is dangerous. It undermines the FDA's safety controls and programs to control distribution. Off-label prescriptions cause a higher incidence of known side effects as well as unforeseen adverse reactions that can even lead to death.)
Eight years ago, the FDA approved Actiq for pain in cancer patients only when other narcotics failed to help them - an indicator of how dangerous and powerful this drug is.
The Actiq website states that Actiq is "intended to be used only in the care of cancer patients and only by oncologists and pain specialists who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain."
Even with these warnings, doctors are prescribing this drug to their patients who do not have cancer. In fact, less than one percent of Actiq prescriptions are written by oncologists. A research firm suggested that, between June 2005 and October 2006, more than 80 percent of patients prescribed Actiq did not have cancer. Instead, it has been prescribed for non-approved uses such as migraine and back aches.
"My neurologist gave me six samples of this drug and I obtained 100% pain relief within 15 minutes or even less," says an individual on a migraine blog site. "My pain management doctor said that he has a migraine patient who takes them around the clock. She has a life back again," says another.
Actiq is administered either by "lollilop" (an oral lozenge designed for child cancer patients or patients who have trouble swallowing), transdermal patches or injection. The drug is highly addictive, being 100 or more times more powerful than morphine, making it the drug of choice for pain relief in many sufferers and also drug of choice for non-patients: it is much more potent than heroin. Many cases of Actiq abuse have been reported and many people have overdosed.
Actiq has been linked in the last few years to hundreds of overdose deaths around the country, particularly in Michigan, Florida and Illinois. Sadly, some people have no idea how dangerous it could be to suck on a lollipop. Known by abusers as "perc-o-pops" or simply "lollipops," they can lower blood pressure, severely slow breathing and for some users, lead to death. People most often obtain it through forged prescriptions or buy it or steal it from people with legitimate prescriptions. Its street name, when combined with heroin, is called "magic" - but it can also be called fatal.
Cephalon Inc. has reported 127 deaths in patients taking Actiq. An additional 91 serious, non-fatal, injuries have also been reported to the FDA, ranging from respiratory distress to severe dehydration.
Actiq is a very dangerous drug, like any other opioid analgesic, and can easily be abused, both legally and illicitly: off-label prescription abuse is just as dangerous and much more prevalent than purchasing the drug on the black market. Currently, Cephalon's marketing practices are being investigated by the U.S. attorney's office in Philadelphia.