History of Fentanyl

As reported by the United States Drug Enforcement Administration, Fentanyl was first made in Belgium in the late 1950s. It entered into medical practice in the 1960s as an analgesic (pain-killer) injection under the name Sublimaze®. Fentanyl is a potent Schedule II opiate (narcotic) medication.  Opiates alter the way the brain and nervous system respond to pain. When used as a pain killer, fentanyl’s potency is 80 times that of morphine. Fentanyl currently has many different forms and is used extensively for the purposes of an anesthesia and as a pain-killer.

The Fentanyl Patch

Overall, fentanyl is often used in operating rooms and intensive care units. The fentanyl transdermal patch (Durogesic/Duragesic) is used to manage chronic pain, ranging from moderate to severe levels of pain, which is expected to last for weeks or longer. Fentanyl patches release fentanyl into body fats and the drug is then slowly absorbed into the blood stream. This process allows for prolonged pain relief.

The patches are now produced generically and are available for lower cost. Current manufacturers include Johnson & Johnson’s Alza Corp., Novartis AG’s Sandoz unit, Actavis (Abrika), and PriCara, a division of Ortho-McNeil-Janssen Pharmaceuticals (another Johnson & Johnson company).

Transdermal fentanyl patches are sold in five patch sizes:

• 12.5 µg/h (micrograms/hour)
• 25 µg/h
• 50 µg/h
• 75 µg/h
• 100 µg/h.
  

The size of the patch generally determines the dosage. Although the rate of absorption is generally constant, certain factors may produce different results. These factors include body temperature, skin type, placement of the patch, and type of delivery system used. A typical patch will take effect in about 8-12 hours.

As a Schedule II pharmaceutical, a licensed medical doctor must prescribe fentanyl. Transdermal patches are only prescribed for people who have become used to the effects of narcotic pain medication due to prolonged use (at least one week).

Side Effects of Fentanyl Patches

Fentanyl skin patches have been known to cause many of the following side effects, which if they do not dissipate demand medical attention:

• Headache
• Mood changes
• Nervousness
• Depression
• Confusion
• Memory problems
• Hallucinations
• Weakness
• Dizziness
• Difficulty falling asleep or staying asleep
• Uncontrollable shaking of a part of the body
• Pain, burning, tingling, or numbness in the hands or feet
• Dry mouth
• Hiccups
• Stomach pain
• Indigestion
• Gas
• Diarrhea
• Constipation
• Nausea
• Vomiting
• Loss of appetite
• Back pain
• Difficulty urinating
• Itching
• Skin irritation, redness, itching, swelling, or blisters in the area where you wore the patch
• Sweating

The following serious side effects require immediate medical attention:

• Heartbeat that is faster than normal
• Chest pain
• Rash
• Seizure
• Coughing up blood

Warning on Fentanyl

The National Institute of Health (NIH) has issued an extensive warning relating to the use of fentanyl:

Fentanyl skin patches should only be used to control moderate to severe chronic (around the clock, long-lasting) pain that cannot be controlled by the use of other pain medications in people who are tolerant (used to the effects of the medication) to narcotic pain medications because they have taken this type of medication for at least 1 week. Fentanyl skin patches should not be used to treat mild pain, short-term pain, pain after an operation or medical or dental procedure, or pain that can be controlled by medication that is taken as needed.

The NIH advises that using fentanyl patches can be very dangerous, especially within the first 72 hours. Patients with a history of breathing difficulties, asthma, chronic obstructive pulmonary disease (COPD), or other lung disease require extra caution.

You should also inform your doctor if you have or are taking any of the following medications because of their possible negative reaction with fentanyl:

• Certain antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral)
• Clarithromycin (Biaxin, in Prevpac)
• Nefazodone
• Nelfinavir (Viracept)
• Ritonavir (Norvir, in Kaletra)
• Troleandomycin (TAO)

Upon beginning use of a fentanyl patch, if you have any of the following symptoms, contact a doctor immediately:

• Difficulty breathing
• Extreme drowsiness with slow breathing
• Heartbeat that is slower than normal
• Cold, clammy skin
• Difficulty thinking, talking, or walking normally
• Dizziness
• Small, pinpoint pupils
• Confusion
• Extreme tiredness
• Fainting
• Loss of consciousness

Emergency overdose

Symptoms of overdose may include:

• Difficulty breathing
• Extreme sleepiness or tiredness
• Difficulty thinking, talking, or walking normally
• Faintness
• Dizziness
• Confusion
• Coma (loss of consciousness for a period of time)

Overdose may lead to death. The Food and Drug Administration’s (FDA) has warned the public about an overdose risk due to exposing the patch to heat. If you or a loved one experiences any of the above symptoms, seek immediate medical attention.

Manufacturer Recalls of Fentanyl Patches

Overdoses may also occur due to leaking or otherwise damaged patches caused by manufacturing defects. These defects can increase the likelihood of direct contact of fentanyl gel with the skin. The manufacturers advise anyone who comes in direct contact with the gel to thoroughly rinse the exposed skin with large amounts of water only. They specifically warn individuals not to use soap because the use of soap may enhance the drug’s ability to penetrate the skin. Any damaged patches should be immediately disposed of by flushing them down the toilet.   

In February 2008, Johnson & Johnson’s PriCara and Sandoz Inc. (a unit of Novartis AG) announced a nationwide recall of all lots of 25 mcg/hr Duragesic Patches sold in the United States. These patches were all made by Johnson & Johnson’s Alza unit. The recall is due to some of the patches having a cut along one side of the drug reservoir within the patch. This cut may release fentanyl gel, causing direct exposure of the fentanyl gel to patients or caregivers.

In March 2008, Actavis, Inc. recalled 14 lots of Fentanyl transdermal system CII patches in the following doses: 25 mcg/hr, 50 mcg/hr, 75 mcg/hr and 100 mcg/hr. These patches have been sold under both the Actavis and Abrika brands. Actavis claims the recall to be a precaution and lists the official reason as the “product may have a fold-over defect which can cause the patch to leak and expose patients or caregivers directly to the fentanyl gel.”

In August 2008, Watson Pharmaceuticals, Inc. announced that one lot of 75 mcg/hr Fentanyl Transdermal System patches is being recalled. Some of the patches in this lot have been detected as leaking fentanyl gel, which has the potential of exposing patients or caregivers directly to fentanyl gel and the ensuing health risks.

Seek Qualified Legal Advice Regarding Defective Fentanyl Patches

Overdoses and injuries caused by pharmaceutical based manufacturing defects like the ones prompting these recalls can be devastating. If you or a loved one has suffered injuries from the fentanyl transdermal system, please contact the National Justice Coalition for a confidential evaluation by a qualified attorney with extensive experience in drug defect injury litigation.