FWD: RSD World News-Fentanyl patches warnings

RSD In the News : FWD: RSD World News-Fentanyl patches warnings
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From: byrd45 (Original Message) Sent: 5/23/2005 2:21 PM
In February, the FDA approved revisions to the safety labeling for
fentanyl transdermal system (Duragesic, made by Alza Corp.) to advise
of contraindications and warnings associated with its use.

Fentanyl is a potent opioid agonist that is classified by the FDA as a
schedule II substance. Schedule II substances such as fentanyl,
hydromorphone, methadone, morphine, oxycodone, and oxymorphone have
the highest potential for abuse and associated risk of fatal overdose
due to respiratory depression.

The FDA warns that serious or life-threatening hypoventilation may
occur at any time during patch use, especially during the first 24 to
72 hours after therapy initiation or dose escalation.

Due to this risk, use of the patch is contraindicated in patients who
are not opioid-tolerant. It is also contraindicated for the management
of acute, postoperative (including outpatient and day surgery), mild,
or intermittent pain. The FDA notes that fentanyl can be abused and is
subject to criminal diversion.

Use of the fentanyl patch is likewise contraindicated in patients with
known hypersensitivity to fentanyl or other components of the product.

Patients and caregivers are advised to avoid exposure of the patch
application site to direct external heat sources because of the
potential for temperature-dependent increases in fentanyl release that
may result in overdose and death. Heat sources include heating pads,
electric blankets, heat lamps, saunas, hot tubs, and heated water beds.

Concomitant use of the fentanyl patch with other central nervous
system (CNS) depressants is associated with an increased risk of
respiratory depression, hypotension, profound sedation, and coma. When
fentanyl is administered in conjunction with other opioids, sedatives,
hypnotics, tranquilizers, general anesthetics, phenothiazines,
skeletal muscle relaxants, alcohol, or other CNS depressants,
significant dose reduction of one or both agents is advised.

The fentanyl transdermal system is indicated for management of
persistent, moderate to severe chronic pain that requires continuous,
around-the-clock opioid administration for an extended period of time