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Limited Use
[what does this mean?]
Generic drug name:
fentanyl [patch]
(FEN ta nil)
Brand name(s):
DURAGESIC,
IONSYS
GENERIC:
not available
FAMILY:
Opiate-containing Painkillers
Find the drug label by
searching at DailyMed.
Pregnancy and Breast-feeding Warnings [top]
Pregnancy Warning
Fentanyl caused fetal death in animal studies. Because of the potential for serious adverse effects to the fetus, this drug should not be used by pregnant women.
Breast-feeding Warning
Fentanyl is excreted in human milk. Because of the potential for adverse effects in nursing infants, you should not take this drug while nursing.
Safety Warnings For This Drug [top]
FDA BLACK BOX WARNING
Addiction, Abuse, and Misuse
DURAGESIC exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing DURAGESIC, and monitor all patients regularly for the development of these behaviors and conditions.
Life-threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of DURAGESIC. Monitor for respiratory depression, especially during initiation of DURAGESIC or following a dose increase. Because of the risk of respiratory depression, DURAGESIC is contraindicated for use as an as-needed analgesic, in non-opioid tolerant patients, in acute pain, and in postoperative pain.
Accidental Exposure
Accidental exposure to even one dose of DURAGESIC, especially in children, can result in a fatal overdose of fentanyl. Deaths due to an overdose of fentanyl have occurred when children and adults were accidentally exposed to DURAGESIC. Strict adherence to the recommended handling and disposal instructions is of the utmost importance to prevent accidental exposure.
Neonatal Opioid Withdrawal Syndrome
Prolonged use of DURAGESIC during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
Cytochrome P450 3A4 Interaction
The concomitant use of DURAGESIC with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving DURAGESIC and any CYP3A4 inhibitor or inducer.
Risk of Increased Fentanyl Absorption with Application of External Heat
Exposure of the DURAGESIC application site and surrounding area to direct external heat sources, such as heating pads or electric blankets, heat or tanning lamps, sunbathing, hot baths, saunas, hot tubs, and heated water beds may increase fentanyl absorption and has resulted in fatal overdose of fentanyl. Warn patients to avoid exposing the application site and surrounding area to direct external heat sources.
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
Facts About This Drug [top]
Fentanyl is a synthetic narcotic that relieves pain. Most studies about fentanyl focus on the injectable form used during surgery. Fewer studies have been done on the transdermal (patch) form, and even fewer studies have been done on older people using fentanyl patches.
Fentanyl patches, which slowly release medication over three days, are used for persistent, moderate-to-severe chronic pain that requires around-the-clock opioid administration for an extended period of time and cannot be...
Fentanyl is a synthetic narcotic that relieves pain. Most studies about fentanyl focus on the injectable form used during surgery. Fewer studies have been done on the transdermal (patch) form, and even fewer studies have been done on older people using fentanyl patches.
Fentanyl patches, which slowly release medication over three days, are used for persistent, moderate-to-severe chronic pain that requires around-the-clock opioid administration for an extended period of time and cannot be managed by other means.[1] Pain relief usually improves sleep. People with swallowing difficulties or poor veins benefit from the topical application. Others find the patch convenient. However, fentanyl is not a Band-Aid for mild or intermittent pain and usually is not used until doses of oral morphine have become high and frequent.
Using cut or damaged patches can cause a high dose of the drug to be released and absorbed, which can be fatal. The first dose of fentanyl is usually 25 micrograms (this refers to the number of micrograms released each hour). Doses must be estimated according to prior use of other analgesics. Older people usually need less fentanyl than younger people. It may take a few days until adequate pain relief is achieved. During the transition, other shorter-acting analgesics relieve breakthrough pain. One drawback of the patches is less flexibility in doses—the patches are currently limited to four sizes and their combinations. People who lose weight may need to have their dose lowered, since fentanyl is stored in fat tissue. Fentanyl should not be used on as-needed basis.
Fentanyl is not recommended for those weighing less than 110 pounds. Common adverse effects of fentanyl are nausea, vomiting, constipation and skin irritation from the adhesive on the patch. Fentanyl patches are not recommended after surgery due to risk of severe respiratory problems. Like morphine, fentanyl is a controlled substance and could be habit-forming. The cost of fentanyl patches is higher than the cost of short-acting oral morphine, similar to long-acting oral morphine, and usually less expensive than injectable morphine, which involves costs for supplies and equipment.
In 2005, the Food and Drug Administration (FDA) issued a Public Health Advisory and added extensive safety warnings to the professional product label of fentanyl in response to reports of death linked to the use of the fentanyl transdermal patch. The new warnings identify several important safety precautions, which are described below.
Fentanyl skin patches should not be used in the following situations:
Fentanyl skin patches also interact with a number of drugs that can increase the amount of fentanyl in the blood to dangerous levels. These drugs include ritonavir (KALETRA, NORVIR), ketoconazole (NIZORAL), itraconazole (SPORANOX), troleandomycin (TAO), clarithromycin (BIAXIN), nelfinavir (VIRACEPT) and nefazodone (SERZONE).
In 2007, the FDA issued another update concerning the appropriate prescribing, dose selection and safe use of the patch. The FDA continues to receive reports of death and life-threatening adverse events associated with fentanyl use.[2]
There have been several reports of serious adverse effects, including death, in patients associated with the buccal (mouth-absorbing) formulation of fentanyl, Fentora. In 2007 the FDA issued a public health advisory highlighting these reports and required that the manufacturer update the label and Medication Guide with additional information on the safe use of Fentora.[3]
In 2010, Prescrire International published an article concerning the risk of drug overdose associated with fentanyl patches. The data reviewed in the article indicated that a potentially fatal overdose of fentanyl may be avoided if the special safety precautions for use and disposal are followed.[4] A copy of the FDA-approved Medication Guide is available here: www.fda.gov/cder/drug/InfoSheets/patient/fentanylPIS.htm.
In 2013, the manufacturer of a fentanyl patch in the UK and the Medicines and Healthcare products Regulatory Agency (MHRA, an agency in the UK similar to the FDA) issued information that serotonin syndrome (see below), a potentially life-threatening condition, can occur when fentanyl-containing products are co-administered with other serotonergic medications (selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors and drugs that impair the metabolism of serotonin [including monoamine oxidase inhibitors]).[5]
The symptoms of serotonin syndrome are:
In 2013, Health Canada issued safety information on the risk of accidental exposure to the fentanyl patch and on the importance of safe use and disposal of the patch to help prevent accidental exposure.[6]
In 2012, Public Citizen filed a petition with the FDA requesting changes in the drug labeling for opioid pain medications in an effort to reduce the massive overprescribing of these medications. The petition states that opioid labels are especially broad because they fail to limit opioid use to severe pain, to include a time frame for use and to specify a maximum dose. Currently, the labels on opioid analgesics simply state that they are approved for moderate-to-severe pain. The petition calls for striking the term “moderate,” inserting a suggested duration of use and adding a suggested maximum dose equivalent of 100 milligrams of morphine. The requested changes relate only to opioids used for non-cancer pain.
If the requested changes are adopted, drug companies no longer would be able to promote these pain medications as safe and effective for long-term use by non-cancer patients.[7]
In 2013, the FDA approved labeling changes to the fentanyl patch (brand name: DURAGESIC) used to treat pain in an effort to prevent accidental exposure in children. Since 1997, the FDA has received 32 reports of accidental exposure to fentanyl patches, most of which involved children younger than 2 years. Twelve children have died from exposure, and 12 more were hospitalized but did not die.[8]
The FDA required color changes to the writing on DURAGESIC pain patches so it can be seen more easily. In an effort to minimize the risk of accidental exposure to fentanyl patches, the FDA requires the manufacturer of DURAGESIC to print the name and strength of the drug on the patch in long-lasting ink, in a color that is clearly visible to patients and caregivers. The FDA continues to learn of deaths from accidental exposure to fentanyl patches.[9]
Patients experiencing MOHs should discuss with their doctors the important details of their headaches and, depending on their individual case, the type of withdrawal from the MOH-causing drugs that is best.[10]
2016: The FDA issued a safety warning for the entire opioid class of drugs concerning potential harmful interactions with other medications, problems with the adrenal glands and decreased sex hormone levels.
The FDA required the addition of a black-box warning, the agency’s strongest warning, to opioid and benzodiazepine drug labels stating that profound sedation, depressed breathing, coma and death can occur when these medications are used together.[11]
Before You Use This Drug [top]
Do not use if you have or have had:
Tell your doctor if you have or have had:
Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.
When You Use This Drug [top]
How to Use This Drug [top]
Interactions with Other Drugs [top]
The following drugs are listed in the Evaluations of Drug Interactions 2003 as causing “highly clinically significant” or “clinically significant” interactions when used together with this drug. We have also included potentially serious interactions listed in the drug’s FDA-approved professional product labeling or package insert. New scientific techniques have allowed researchers to predict some drug interactions before they have been documented in people. There may be other drugs, especially those in the families of drugs listed below, that also will react with this drug to cause severe adverse effects. The number of new drugs approved for marketing increases the chance of drug interactions, and new drug interactions are being identified with old drugs. Be vigilant. Make sure to tell your doctor and pharmacist the drugs you are taking and tell your doctor if you are taking any of these interacting drugs:
People who take monoamine oxidase inhibitors should be off these drugs for 14 days before starting fentanyl.[13] These include: deprenyl, ELDEPRYL, furazolidone, FUROXONE, isocarboxazid, MARPLAN, MATULANE, NARDIL, PARNATE, phenelzine, procarbazine, selegiline, tranylcypromine.
Central nervous system (CNS) depressant drugs, including alcohol, antidepressants, antihistamines, antipsychotics, some blood pressure medications (reserpine, methyldopa, beta-blockers), motion sickness medications, muscle relaxants, narcotics sedatives, sleeping pills, and tranquilizers. Doses of fentanyl and any of these drugs may need to be lowered by 50%. If any of these drugs are discontinued while you use fentanyl, adjustments in doses may be required.
Other drugs that can interact with fentanyl are: carbamazepine, DILANTIN, EES, erythromycin, ketoconazole, MERIDIA, naltrexone, NIZORAL, NORVIR, phenytoin, REVIA, RIFADIN, rifampin, ritonavir, sibutramine, TEGRETOL.
Adverse Effects [top]
Call your doctor immediately if you experience:
Call your doctor if these symptoms continue:
Call your doctor if these symptoms continue after you stop taking this drug:
Periodic Tests[top]
Ask your doctor which of these tests should be done periodically while you are taking this drug:
last reviewed August 31, 2024
Worst Pills, Best Pills is a project of Public Citizen's Health Research Group Group. As an independent, nonprofit organization, we take no corporate or government contributions and accept no advertising. Copyright © 2024 Public Citizen's Health Research Group. All rights reserved.
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