Drug Topics - October 22, 2007 - (Page H8)

8HSE DRUG TOPICS OCTOBER 22, 2007 www.drugtopics.com Clinical Practice Warning letters raise patient safety concerns for Fentora Mona Nashed, Pharm.D. ously introduced Actiq, which is better known as the “fentanyl lollipop,” as the first medication approved for the treatment of breakthrough pain in opioid-tolerant cancer patients. However, both Fentora and Actiq have often been prescribed for “off-label” uses in patients who don’t have cancer. Although Cephalon denies marketing the drugs outside of their indication, its sales and marketing practices are currently under investigation by the Connecticut Attorney General’s office as well as by the House Committee on Oversight & Government Reform. Cephalon has been under scrutiny since 2004, when it received subpoenas from the U.S. Attorney’s office in Philadelphia related to marketing tactics for Actiq. I n response to a number of deaths and serious adverse events reported by patients taking fentanyl buccal tablets (Fentora, Cephalon), warning letters were sent on Sept. 10 to physicians and healthcare professionals by the manufacturer. According to the company, the deaths occurred primarily as a result of improper patient selection, improper dosing, and/or improper product substitution. Fentora, which is a Schedule II controlled buccal formulation of fentanyl, is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and are tolerant to opioid therapy for their underlying persistent cancer pain. Cephalon previ- Advisory issued The Food & Drug Administration issued a Public Health Advisory on Sept. 26 to alert patients, caregivers, and healthcare professionals to the potential for serious adverse events with improper use of Fentora. The agency has also asked Cephalon to update the Fentora label and http://www.drugtopics.com http://www.emporos.net http://www.emporos.net

Table of Contents Feed for the Digital Edition of Drug Topics - October 22, 2007

Drug Topics - October 22, 2007 Contents Latebreakers Legislative Victory Builds Momentum for Pharmacy Month Letters Health-System Edition R.Ph.s Brace for Payment Denial for Hospital-Acquired Conditions Topical Human Thrombin Helps Arrest Bleeding FDA Panels Fail to Set Target Levels for Renal Patients’ Hemoglobin Warning Letters Raise Patient Safety Concerns for Fentora Ending/Reversing Weight Gain Man Given Fatal Drug Overdose at Staten Island Hospital Pharmacists Playing More Important Role in Dialysis Treatment AHA President R.Ph.'s Here's How You Can Increase Your Value Premier Launches Comprehensive Quality Improvement Project FDA Approves Dexrazoxane for Treatment of Extravasation New Federal, State Reforms to Ease Disaster Relief Kinks 150 Years of American Pharmacy Ten Tips for MTM Success Independent Superstars: The Ones to Watch The New Dynamic Duo A Parkinson's Disease Primer Classified New Products Advertisers Index Viewpoint

Drug Topics - October 22, 2007

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