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FDA Drug Safety Podcasts
Transcript Welcome to the Food and Drug Administration's drug safety update. I am Pat Clarke from F-D-A's Center for Drug Evaluation and Research. On December 21, 2007 we issued a public health advisory titled: Important Information for the Safe Use of Fentanyl Transdermal System. The Fentanyl Transdermal System is also known as the fentanyl patch and marketed as Duragesic and in generic versions. The fentanyl patch is a narcotic, opiod, pain medicine applied to the skin for treating persistent moderate to severe pain in opioid-tolerant patients who need to be on a narcotic pain medicine around-the-clock for more than a few days. Despite issuing an advisory in July 2005 that emphasized the safe use of the fentanyl patch, FDA continues to receive reports of death and life-threatening side effects in patients who use the fentanyl patch. Fentanyl is a very potent narcotic pain medicine. For patients who are not opioid-tolerant, the amount of fentanyl in one fentanyl patch of the lowest strength is large enough to cause dangerous side effects such as severe trouble breathing or very slow or shallow breathing. Use of fentanyl patches in such cases can even result in death. FDA is highlighting the following important safety information on the fentanyl skin patch:
To hear the full public health advisory, listen to part two of this broadcast. We urge healthcare providers and patients to report side effects that occur while using fentanyl patches to us at the FDA's MedWatch adverse event reporting program by phone at 1-800-F-D-A-ten-88 or by the Internet at F-D-A dot GOV slash M-E-D-W-A-T-C-H. Additional Information
Date created: December 21, 2007 |
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