FDA ACTION ON FENTANYL
RECALLS PLUS RISK EVALUATION AND MITIGATION STRATEGY
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| 1995 | Manufacturers report first problems |
| December, 2004 | FDA warns patients and doctors of high danger of accidental overdose with Duragesic pain patch after recall earlier in the year because of leakage problems in 75 mcg/hr patches manufactured by Janssen Pharmaceutical Products. |
| July 15, 2005 | FDA issues first Public Health Advisory after inquiry into deaths and severe side effects reported in connection with Duragesic fentanyl patches and their generic versions. FDA says 120 deaths have been reported. |
| December 21, 2007 | FDA updates its danger alert after receiving numerous additional reports of overdoses associated with fentanyl patches. The agency issues Safety Warnings Regarding the Use of Fentanyl Transdermal Patches. Physicians, patients, and caregivers are advised to be sure to read product directions, and are warned that lethal overdose is possible. |
| February 17, 2008 | Actavis Inc. announces voluntary recall of 14 lots of its fentanyl transdermal system from wholesalers and pharmacies. Patches from these lots may have foldover defect that causes the patch to leak and expose patients or caregivers directly to the fentanyl gel. |
| December 31, 2008 | PriCara, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. and parent company Johnson & Johnson, announce voluntary recall of 50 mcg/hr Duragesic and Sandoz Inc. fentanyl patches, which were manufactured by ALZA Corporation. Possible cut on one side of drug reservoir could result in direct contact with the fentanyl gel by patient or caregiver. |
| February 6, 2009 | FDA sends letters to manufacturers of opioid drugs, including fentanyl, requiring Risk Evaluation and Mitigation Strategies (REMS) to demonstrate that the drugs’ benefits outweigh their risks. |
| March 3, 2009 | First scheduled meeting between FDA and makers of fentanyl and other opiate drugs to discuss the development of REMS.
Subsequent REMS steps: Discussions with other federal agencies, non-government institutions, patient and consumer groups, representatives of pain and addiction treatment centers, and other healthcare professionals. Public meeting in late spring or early summer 2009 to encourage broader public input into practical and effective solutions for safe and appropriate use of opiate-based painkillers. |