Off-label use of Actiq could have dangerous results

posted on:
April 4, 2010

author:
JENNIFER WALKER-JOURNEY

Ed McAteer relies on the powerful opioid Actiq to help him “survive as a human being.” He suffers from painful migraines so severe he says that a whiff of fresh-cut grass can cause him extreme headaches. His doctor prescribed him Actiq, a fentanyl citrate that comes in a lollipop lozenge. It is only approved by the Food and Drug Administration (FDA) for the treatment of breakthrough pain in cancer patients already on around-the-clock opiods. But McAteer’s doctor, a renowned pain specialist at Beth Israel Medical Center in New York, felt the application would be both safe and effective for his patient.

Cancer patients are warned not to ingest more than 120 doses of Actiq per month. However McAteer, who does not have cancer, goes through as many as 300 pops per month – enough that the sugar content has corroded away all his teeth. Yet, McAteer says, “Actiq is the best thing I’ve ever tried.”

Off label prescribing of drugs is not illegal; however, the FDA says that it specifically did not approve the drug’s use for migraines, backaches and injuries because not enough data was available to support its safety. Further, the drug is in the same class as morphine and considered more potent, which makes it susceptible to misuse and abuse. Despite these warnings, doctors continue to prescribe Actiq in the manner for which it is not approved. One investigation showed as many as 80 percent of the 400,000 prescriptions written in one year for Actiq and its generic were for its off-label use.

Why is this a problem if people without cancer are finding relief from chronic pain? Because the drug is unsafe, says the FDA. At least 127 deaths have been associated with Actiq and another 91 incidents of severe side effects have been linked to its use.

Source: Newsweek 

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