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Schmidt & Clark, LLP Contacted by Actiq Users Claiming Off-Label Use
(PRLEAP.COM) Schmidt & Clark, LLP, a mass torts law firm has reported receiving a significant number of inquiries from Actiq users claiming that their doctor prescribed the drug to them for an ‘off-label’ use.
Approved by the U.S. Food & Drug Administration (FDA) in 1998, Actiq (oral transmucosal fentanyl citrate) is a prescription medication indicated ONLY for the management of breakthrough cancer pain in patients with malignancies who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. The drug comes in the form of a flavored sugar lozenge that dissolves in the mouth while held by an attached handle. Users of the drug describe Actiq as a berry-flavored lozenge on a stick that looks and tastes like a lollipop. Recently, data gathered from doctors was released by ImpactRx showing that between June 2005 and October 2006 more than 80 percent of patients prescribed Actiq didn’t have cancer. Verispan, has also released a recent statistic showing that for the first half of 2006, oncologists accounted for only 1 percent of the 187,076 Actiq prescriptions filled at retail pharmacies in the United States.
Based upon the aforementioned reports, doctors are prescribing Actiq in an "off label" fashion and for non-approved uses such as migraine headaches and/or back pain. Off-label prescribing by doctors isn’t illegal, but the marketing of a drug to doctors by the manufacturers for off-label use is.
Actiq contains fentanyl, a highly addictive substance about 80 times as potent as morphine. The U.S. Drug Enforcement Administration (DEA) has classified Actiq as a Schedule II substance, which puts it in the same category as opium, cocaine, methamphetamine and methadone. According to the DEA, Schedule II drugs have the highest potential for abuse and associated risk of fatal overdose.??As reported by the Wall Street Journal, “Actiq’s maker, Cephalon Inc., says that it doesn’t market the drug for unapproved uses. While acknowledging Actiq is widely used ‘off-label’, it says it can’t control how doctors prescribe the drug.”
In addition, the article claims in part that the company (Cephalon, Inc.), “walks a fine line by sending its sales representatives to pitch the drug to a broad range of doctors, ranging from sports-medicine specialists to family practitioners. It gives these doctors coupons for free samples. Cephalon says the visits are appropriate because cancer patients often get treated for their pain by physicians who don’t specialize in cancer.”
"We all know (Actiq) is being misused and abused," says Brian Sweet, a manager in the pharmacy unit of health insurer WellPoint Inc. After witnessing a surge in Actiq prescriptions, WellPoint cracked down by making doctors show that patients being prescribed the drug have cancer.??Michael Schmidt, Managing Partner of Schmidt & Clark has noticed an alarming number of inquiries to the firm related to Actiq.
Mr. Schmidt stated “We are a firm that focuses on mass torts litigation. As a result, we have received a large number of inquiries where the party has stated that they were prescribed Actiq for migraine headaches and/or back pain. While the FDA only approved the drug for use in cancer patients and based on the number of calls to my office from callers stating that they DO NOT have cancer and the recent reports released by ImpactRx and Verispan, it would appear that the manufacturer quite possibly marketed the drug for ‘off-label’ use to doctors.”
About Schmidt & Clark, LLP
Schmidt & Clark is a national law firm that focuses on mass torts and drug side effect lawsuits.
Schmidt & Clark is currently evaluating potential Actiq lawsuits in all 50 states whereby the patient has been prescribed Actiq by a physician for ‘off-label’ use, i.e. prescribed the drug for migraine headaches, back pain or other forms of pain management, although the patient has not been diagnosed with cancer.
For more information on Schmidt & Clark, LLP, please visit: http://www.schmidtandclark.com or call toll free 24 hrs/day (866) 588-0600.??Actiq users can learn more about their legal rights and receive a free case evaluation by clicking the following link:
Free Actiq Lawsuit Review
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