What Is Fentanyl (Duragesic)?
It should be used only by people who are "opioid-tolerant," or who are already taking opioid pain medications, such as morphine and oxycodone, regularly.
Fentanyl is in a class of drugs called opioid analgesics, which work by binding to nervous system proteins called opioid receptors, thereby blocking the transmission of pain signals to the brain.
Duragesic is a transdermal (through-the-skin) patch. Fentanyl is also sold as a lozenge (under the brand Actiq), a tablet that goes under the tongue (Abstral), a film that's applied to the inner lining of the cheek or lip (Onsolis), a tablet that goes between the gum and cheek (Fentora) a nasal spray (Lazanda), a sublingual tablet (Abstral), and a sublingual spray (Subsys).
The Food and Drug Administration (FDA) first approved fentanyl, which is produced by Johnson & Johnson, in 1968.
Over the years, Johnson & Johnson has issued several recalls of its Duragesic pain-relief skin patches.
In 2004 and 2008, the company recalled some of its patches because of damage that could have caused the medication to leak potentially fatal fentanyl gel.
In 2012, Johnson & Johnson recalled more than 53,000 Duragesic patches after fentanyl crystals were found in a patch (the drug is supposed to be completely dissolved).
Fentanyl Abuse
Fentanyl use can lead to addiction, abuse, and misuse, even at the recommended doses — this risk is higher for people with a personal or family history of substance abuse or mental illness.Fentanyl is almost 100 times more potent than morphine, but the drug is designed to deliver small amounts of fentanyl each hour over an extended period of time.
When ingested, however, the Duragesic patch can deliver its entire dose all at once, increasing the risk of an overdose. In 2008, a study in the Journal of Forensic Sciences reviewed seven case reports of oral abuse of Duragesic and found that fentanyl overdose caused or contributed to the deaths of the persons in each case.
Fentanyl Withdrawal
As with other addictive drugs, stopping fentanyl suddenly may result in withdrawal symptoms, including:- Restlessness, yawning, and difficulty falling asleep or staying asleep
- Teary eyes and runny nose
- Sweating and chills
- Muscle, joint, and back pain
- Enlarged pupils
- Irritability and anxiety
- Weakness
- Stomach cramps, nausea, loss of appetite, vomiting, and diarrhea
- Fast heartbeat and rapid breathing
Fentanyl Warnings
Fentanyl carries a black-box warning about its potential for addiction, abuse, misuse, and its associated risk of fatal overdose. People who are accidentally exposed to fentanyl, particularly children, are especially vulnerable to a fatal overdose.Fentanyl should be used only by people with chronic pain who are opioid tolerant.
You should not use it to treat mild, post-operative, intermittent, or short-term pain. People with significant respiratory problems, acute or severe asthma, paralytic ileus (an obstruction of the intestine), or a known sensitivity to fentanyl shouldn't take fentanyl.
People who are non-opioid tolerant shouldn't take fentanyl, because the drug carries a high risk of life-threatening respiratory depression (low breathing rate). Respiratory depression may also occur in opioid-tolerant people, even when the drug is used as directed, especially when first going on fentanyl or increasing the dosage.
If you're older, debilitated, or have a wasting syndrome called cachexia, you're more likely to experience respiratory depression.
Potentially fatal respiratory depression may also occur if you use fentanyl while taking cytochrome P450 3A4 (CYP3A4) inhibitors, such as ritonavir (Norvir), nefazodone (Serzone), nelfinavir (Viracept), and while drinking grapefruit juice.
Using fentanyl while taking central nervous system depressants, such as sedatives, hypnotics, alcohol, and other opioids, can cause abnormally low blood pressure, profound sedation, coma, respiratory depression, and death.
When using fentanyl, don't expose the patch or surrounding area to direct external heat sources such as saunas, hot tubs, and heating pads, as this may increase your body's rate of fentanyl absorption, possibly leading to a fatal overdose.
You're also at risk for increased fentanyl exposure if you have a fever or an increased core body temperature, such as from strenuous exercise.
Pregnancy and Fentanyl
Prolonged use of opioid analgesics (painkillers), including fentanyl, during pregnancy can produce drug dependence in newborns. It can also result in neonatal opioid withdrawal syndrome, which has various symptoms and signs, including:- Poor feeding and irritability
- Diarrhea
- Tremor and seizures
- Rigidity
It should only be used during pregnancy if the potential pain-relieving benefits outweigh the potential risks to the fetus.
Fentanyl shouldn't be used during or immediately before labor because opioids can cross the placenta and potentially cause respiratory depression in newborns. The drug may also prolong labor.
Because fentanyl is excreted in breast milk, do not use fentanyl if you're breastfeeding.
Fentanyl (Duragesic) Side Effects
Common Side Effects of Fentanyl
The most common side effects of fentanyl are:- Nausea, vomiting, constipation, and diarrhea
- Drowsiness and dizziness
- Insomnia
- Increased sweating
- Fatigue
- Feeling cold
- Anorexia
- Headache
- Depression
- Abnormally slow heart action
- Muscle spasms and tremors
- Fluid retention and swelling of tissues in the lower limbs
- Abdominal pain
- Anxiety, confusion, and hallucinations
- Urinary problems
- Tingling sensations
Rare Side Effects of Fentanyl
Rare side effects from using fentanyl have also been reported, including:- Euphoria
- Erectile and sexual dysfunction
- Eczema and other skin disorders
- Reduced sense of touch
- Flu-like symptoms
Fentanyl (Duragesic) Interactions
- Monoamine oxidase inhibitors, including isocarboxazid (Marplan) and phenelzine (Nardil)
- Agonist/antagonist analgesics, such as pentazocine (Talwin) and butorphanol (Stadol)
- Partial agonist analgesics, such as buprenorphine (Buprenex)
- Anticholinergics
Fentanyl and Alcohol
Drinking alcohol while using fentanyl may cause low blood pressure, profound sedation, coma, respiratory depression, and death.Fentanyl and Grapefruit
Potentially fatal respiratory depression may occur if you consume grapefruit juice or grapefruit products while taking fentanyl.(Respiratory depression can also occur if you're taking fentanyl with cytochrome inhibitors.)
Fentanyl (Duragesic) Dosage
Use only as directed — never put more than one patch on at a time.
Fentanyl Overdose
If you overdose on fentanyl, get emergency help right away. Overdose symptoms include:- Difficulty breathing
- Extreme sleepiness or fatigue
- Difficulty thinking, talking, or walking
- Contracted pupils
- Faintness and dizziness
- Confusion
- Coma
