Special Alerts:

[Posted 12/21/2007] FDA issued an update that highlights important information on appropriate prescribing, dose selection, and the safe use of the fentanyl transdermal system (patch). FDA previously issued a Public Health Advisory and Information for Healthcare Professionals in July 2005 regarding the appropriate and safe use of the transdermal system. However, the Agency continues to receive reports of death and life-threatening adverse events related to fentanyl overdose that have occurred when the fentanyl patch was used to treat pain in opioid-naive patients and when opioid-tolerant patients have applied more patches than prescribed, changed the patch too frequently, and exposed the patch to a heat source. The fentanyl patch is only indicated for use in patients with persistent, moderate to severe chronic pain who have been taking a regular, daily, around-the-clock narcotic pain medicine for longer than a week and are considered to be opioid-tolerant.

Patients must avoid exposing the patch to excessive heat as this promotes the release of fentanyl from the patch and increases the absorption of fentanyl through the skin which can result in fatal overdose. Directions for prescribing and using the fentanyl patch must be followed exactly to prevent death or other serious side effects from fentanyl overdose. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Fentanyl , http://www.fda.gov/cder/drug/advisory/fentanyl_2007.htm and http://www.fda.gov/cder/drug/InfoSheets/HCP/fentanyl_2007HCP.htm.

[UPDATED 09/26/2007] FDA issued a Public Health Advisory and a Healthcare Professional Sheet to alert healthcare professionals and consumers regarding concerns over the use of Fentora (fentanyl buccal) tablets after recent reports of deaths and other adverse events. The deaths reported were the result of improper selection of patients, dosing, or improper product substitution.

FDA warned physicians and other healthcare professionals that it is critical to follow product labeling when administering Fentora. FDA further stated that it is dangerous to use Fentora for any short-term pain such as headaches or migraines. It is critical that Fentora not be used in patients who are not opioid tolerant.

Patients also must be under a doctor’s care and close supervision while taking Fentora and the dose should be carefully adjusted to control breakthrough pain adequately.

In addition, FDA is concerned about the improper substitution of Fentora, a quick acting pain drug, for other pain medicines. Fentora is not the same as other fentanyl products and cannot be substituted for Actiq, another fentanyl product used to treat breakthrough cancer pain. Because Fentora delivers more fentanyl to the blood than Actiq, substituting Fentora for Actiq using the same dose can result in a fatal overdose. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Fentora, http://www.fda.gov/cder/drug/advisory/fentalyn_buccal.htm and http://www.fda.gov/cder/drug/InfoSheets/HCP/fentanyl_buccal.htm

[Posted 09/13/2007] Cephalon issued two Dear Healthcare Professional Letters to inform prescribers and other healthcare providers of important safety information regarding fentanyl buccal tablet (Fentora). Fentanyl buccal tablet is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Serious adverse events, including deaths, have occurred in patients treated with fentanyl buccal tablet. These deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients), improper dosing, and/or improper product substitution. The healthcare professional letters provide key points regarding appropriate patient selection and proper dosing and administration of fentanyl buccal tablet to reduce the risk of respiratory depression. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Fentora, http://www.fda.gov/medwatch/safety/2007/fentora_deardoc_%20Letter_09-10-07.pdf, http://www.fda.gov/medwatch/safety/2007/Fentora_DearHCP_Letter%2009-10-07.pdf and http://www.fda.gov/medwatch/safety/2007/fentora_PI_9-12-07.pdf.