The U.S. FDA issued a Public Health Advisory today to warn patients about increasing numbers of reports of death and other serious side effects in patients using fentanyl transdermal skin patches for pain control. Fentanyl is the active ingredient in the brand name pharmaceutical product Duragesic, manufactured by Johnson & Johnson, and is also available in generic form, manufactured by Mylan Laboratories. Fentanyl is an extremely strong narcotic pain killer that can cause death from overdose and may be linked to 120 deaths being investigated by the agency.

Signs of fentanyl overdose include:

• Trouble breathing or shallow breathing
• Tiredness, extreme sleepiness or sedation
• Inability to think, talk, or walk normally
• Feeling faint or dizzy
• Mental confusion

Patients exhibiting signs of overdose should be given medical attention immediately. These patches are normally prescribed for cancer patients, burn victims and others experiencing excruciating and continual pain. It gained notoriety in 2002 when Russian authorities attempted to end a hostage crisis at a Moscow theatre by pumping in a sleeping gas reported to contain fentanyl. Although the authorities meant to put the hostages and their Chechen captors to sleep, 120 of the 750 hostages died from breathing the gas.

Patients overdosing on fentanyl experience a decrease in the lung’s drive to breathe. Patients usually become comatose prior to death. Prescriptions for Duragesic reached 4 million in 2004.

The FDA issues the following strong warnings concerning Fentanyl:

• The Duragesic (fentanyl) skin patch should always be prescribed at the lowest possible dose needed for pain relief
• The Duragesic (fentanyl) skin patch should only be used if a patient has been taking at least 60 mg or oral morphine, at least 30 mg of oral oxycodone, or at least 8 mg of oral hydromorphone daily for a week or longer
• Duragesic (fentanyl) skin patches should not be used to treat short-term pain, pain that is not constant, or for pain after an operation
• Duragesic (fentanyl) skin patches should be stored in a safe place, out of the reach of children
• Potentially fatal effects from Duragesic (fentanyl) can be stronger if the patient drinks alcohol or uses other medications that affect brain function
• Potentially fatal effects from Duragesic (fentanyl) can be stronger if patients have an increase in body temperature or exposed to heat
• Do not use the Duragesic (fentanyl) skin patch if you have acute (sudden) or severe asthma
• Do not use the Duragesic (fentanyl) skin patch if you have a gastrointestinal problem known as paralytic ileus

Sources: Ricardo Alonso-Zaldivar, “Pain-Relief Patch is Investigated in Patient Deaths,” Los Angeles Times, July 16, 2005; “Mylan will work with FDA on Pain Patch Probe,” Reuters, July 18, 2005.