Fifty-six patients from one health care clinic have died and 96 others were sent to the emergency room with overdoses after taking a powerful painkiller for a use not approved by the Food and Drug Administration (FDA). The drug in question is Cephalon’s Actiq, a opioid approved by the FDA to treat breakthrough pain in cancer patients already being treated around-the-clock with opioids.

Actiq also has an off-label use, one the FDA refused to approve, for the treatment of headaches, backaches and chronic pain. It is this off-label use that Dr. Stephen Schneider, a Kansas physician, took advantage of. His clinic routinely dished out Actiq for headaches and backaches without regard to how dangerous the drug could be to patients not already tolerant to opioids.

Doctors are free to prescribe medication for uses other than those approved by the FDA, however the drug companies are not allowed to market their products for any other use than what is listed on the drug’s label. Cephalon, however, ignored this law, paying millions to physicians and other health care professionals to promote to other doctors the use of Actiq for the treatment of headaches and chronic pains. The marketing effort worked amazingly well – more than 80 percent of Actiq’s sales were for its off-label use. In 2007, the law caught up with Cephalon, and the drug company was forced to pay $425 million to the Department of Justice.

But the damage from Cephalon’s aggressive off-label marketing efforts has already been done. Fifty-six people are now dead because they took Actiq for reasons other than those approved by the FDA. And Schneider is facing criminal charges from family members of his victims.

Source: BNet News


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