On December 21, 2007, the United States Food and Drug Administration (FDA) issued a public advisory outlining safe usage of the fentanyl transdermal system, also called the fentanyl patch and marketed as Duragesic and generics.

The fentanyl public advisory and additional prescribing directions to healthcare professionals are part of a larger effort to prevent additional deaths from fentanyl overdose.

Explicitly, the FDA offered the following safety guidelines to consumers:

1. The fentanyl patch should only be used by patients who are opioid-tolerant and have chronic pain that is not well controlled with other pain medications.
2. Healthcare professionals who prescribe and patients who use the fentanyl patch should be aware of the signs of fentanyl overdose. If these signs occur, patients or their caregivers should get medical attention right away:
3. trouble breathing or slow or shallow breathing;
4. slow heartbeat;
5. severe sleepiness;
6. cold, clammy skin;
7. trouble walking or talking; or
8. feeling faint, dizzy, or confused.
9. Patients prescribed the fentanyl patch should tell their doctor about all the medicines they take.
10. Patients and their caregivers should be told how to use the fentanyl patch.
11. Heat may increase the amount of fentanyl that reaches the blood and can cause life-threatening breathing problems and death.

The FDA warned consumers about the possible dangers of fentanyl in July of 2005, but continues to receive reports of fentanyl overdoses that may cause serious health problems.

Sources: U.S. Food and Drug Administration, “Information for Healthcare Professionals Fentanyl Transdermal System (marketed as Duragesic and generics);” “FDA Public Health Advisory Important Information for the Safe Use of Fentanyl Transdermal System Patch);” December 21, 2007.