Drug Topics - April 14, 2008 - (Page 40)

40 DRUG TOPICS APRIL 14, 2008 www.drugtopics.com FDA SAFETY PAGE How to use Fentora safely Loretta Holmes, Pharm.D. Carol Holquist, R.Ph. F entora (fentanyl buccal tablet), manufactured by Cephalon, received Food & Drug Administration approval on September 25, 2006. Fentora is a potent opioid analgesic (C-II) indicated for the management of breakthrough pain in cancer patients who are tolerant to round-the-clock opioid therapy for persistent cancer pain. Since approval, the FDA has received reports of serious life-threatening side effects, including death, in patients who had taken Fentora for off-label uses, were not tolerant to opiate medications, or were not on concurrent round-the-clock opioid therapy. In addition, the FDA has received reports of patients who were prescribed the wrong dose, or were inappropriately administered Fentora in substitution for another fentanyl-containing product that is not equivalent to Fentora on a microgram for microgram (mcg/mcg) basis. FDA issued a Public Health Advisory and a Healthcare Professional Sheet on September 26, 2007, to alert healthcare professionals and consumers about Fentora after receiving numerous adverse event reports concerning the incorrect use and misuse of the drug. FDA warned physicians and other healthcare professionals that it is critical to follow the instructions provided on the product labels when prescribing and administering Fentora. The FDA further stated that it is dangerous to use Fentora for any short-term pain such as headaches or migraines. Fentora should not be used in patients who are not tolerant to round-the-clock opioid therapy. Patients must also be under a doctor’s close supervision while taking Fentora. The dosing of Fentora must be carefully adjusted to control breakthrough pain adequately. Additionally, FDA warned against the improper substitution of Fentora, a quick-acting pain drug, for other pain medicines. Fentora is not the same as, or comparable to, other fentanyl products. Fentora must not be substituted on a mcg/mcg basis for Actiq, another fentanyl product, used to treat breakthrough cancer pain. A direct microgram substitution should not be done because Fentora delivers more fentanyl to the blood than Actiq, increasing the possibility of a fatal overdose. We would like to highlight the following important safety information communicated in the Fentora Public Health Advisory: • Fentora should only be used for breakthrough pain in patients with cancer who are tolerant to round-theclock opioid therapy. • Fentora should not be used to treat any type of shortterm pain including headaches or migraines, postoperative pain, or pain due to injury. • Fentora should not be used by patients who take narcotic pain medications occasionally. • The dosage strength of fentanyl in Fentora is NOT equal to the same dosage strength of fentanyl in other fentanyl-containing products. • Healthcare professionals must not directly substitute Fentora for other fentanyl medicines, including Actiq. • Doctors must select the Fentora dose carefully for each patient. • Patients who take Fentora and their caregivers must understand how to use it safely and follow the directions exactly. Directions for taking Fentora are provided in the Medication Guide for patients. • Healthcare professionals who prescribe Fentora and patients who use Fentora and their caregivers should be aware of the signs of fentanyl overdose, which include trouble breathing or shallow breathing; tiredness, extreme sleepiness, or sedation; inability to think, talk, or walk normally; and feelings of faintness, dizziness, or confusion. If these signs occur, patients or their caregivers should get medical attention right away. The Fentora product labeling and Medication Guide have been updated to include this new safety information. As the pharmacist, you should familiarize yourself with Fentora's approved indication of use, dosing, and administration to ensure its safe use. Be aware that there are specific dose conversion recommendations stated in the package insert labeling for switching a patient from Actiq to Fentora. Be alert to off-label use of the product (e.g., acute pain, migraine headaches), prescribing to patients who are not tolerant to round-the-clock opioid therapy, etc.), and follow up with the prescriber if necessary. Finally, counsel patients on the proper use and administration of Fentora. If you become aware of medication errors or other adverse events involving Fentora or other products, please report them to the FDA MedWatch program online at www.fda.gov/medwatch. LORETTA HOLMES is a Safety Evaluator and Carol Holquist is Director in the Division of Medication Error Prevention, The Office of Surveillance and Epidemiology at the FDA. http://www.drugtopics.com http://www.fda.gov/medwatch

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Drug Topics - March 14, 2008 Contents Latebreakers Letters: Students Need Grounding in Chemistry Pharmacy Directors Wary of Heparin Shortages Some E-prescribing Standards are Ready to Go, Others are Not News Briefs Nanotechnology: Big Stakes in a Small World Pay for Performance is Coming to Pharmacy Patient Safety Organizations Still Very Much in Planning Stage Reconciling Medications in Specialty Patients Poses More Challenges Pharmacy Outsourcing Still Much in Use by Hospitals Studied Extensively, New Drug-Eluting Stent Said to be Very Safe Prevention is Key in Treating C. Difficile Infections E-prescribing Grows in Massachusetts, but Other States Lag Behind Active Metabolite Gives New Life to Antidepressant NSAIDS not Recommended for Long-term Use in Osteoarthritis This Time R.Ph.s and States Are Ready for Tamper-Resistant Rx Pads Cardinal Caught Between DEA and Pharmacies over Diversion Control Medicating Kids: Still More Questions than Answers Schnucks Pharmacy: Drug Topics' Chain of the Year Panel Will Ask for a System for R.Ph. Practice Across State Lines FDA Safety Page: How to use Fentora Safely The Shining OTC/HBC Stars of 2007 Take a Look at These OTCs for Eye Health Technology Update: Google Offers a Sneak Peak at its Electronic Records Initiative Recent Advancements in HIV/AIDS Treatment New Products Advertisers Index Classified Viewpoint: Are State Boards of Pharmacy Abusing Their Power?

Drug Topics - April 14, 2008

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