The Food and Drug Administration ( FDA ) issued a public health advisory to alert health care professionals, patients and their caregivers of reports of death and other serious side effects from overdoses of Fentanyl in patients using Fentanyl transdermal patches for pain control.
Deaths and overdoses have occurred in patients using both the brand name product Duragesic and the generic product.

FDA recently conducted a review of fatalities reported to the voluntary adverse event reporting system that were possibly due to unintentional overdose from the Fentanyl transdermal patch.
In many cases, establishing whether the overdose was unintentional was difficult, because the information provided in the report was incomplete and patients who were being treated with the Fentanyl patch often had underlying diseases or conditions that could have contributed to their deaths ( such as cancer ).

Factors identified as possibly related to unintentional overdose included: use of high doses of the Fentanyl patch and/or multiple patches ( sometimes in combination with other drugs ), possible medication errors, accidental exposure ( e.g., coming in contact with a discarded patch ), application of a heat source to the patch possibly resulting in increased Fentanyl absorption, injection or ingestion of the patch contents, and suspected transdermal patch malfunction ( e.g., leaking patches ).

FDA makes the following recommendations about safety:

- Fentanyl transdermal patches are potent opioid analgesics that may cause death from overdose. The Fentanyl transdermal patch should always be prescribed at the lowest dose needed for pain relief.

- Fentanyl transdermal patches should not be used to treat short-term pain, pain that is not constant, or pain after an operation. Fentanyl transdermal patches should only be used by opiod tolerant patients who are already taking other narcotic analgesics, and who have chronic pain that is not well controlled with shorter-acting analgesics.
Health care professionals who prescribe the Fentanyl transdermal patch and patients who use the Fentanyl transdermal patch and their caregivers should be aware of the signs of Fentanyl overdose.

Signs of Fentanyl overdose include trouble breathing or shallow breathing; tiredness, extreme sleepiness or sedation; inability to think, talk or walk normally; and feeling faint, dizzy or confused.

A patient using the Fentanyl transdermal patch may have a sudden and possible dangerous rise in their body level of Fentanyl or have a more potent Fentanyl effect if they: use other sedating medicines; drink alcohol ( beer, wine or distilled spirits ); have an increase in body temperature or are exposed to heat; or use other medicines that increase the elimination half-life of Fentanyl ( such as cytochrome P450 3A4 inhibitors ).

Source: FDA,2005


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