TOPIC: Opioid Pain Relievers or Medicines to Treat Opioid Use Disorder: MedWatch Safety Alert - FDA Recommends Health Care Professionals Discuss Naloxone with All Patients when Prescribing.
AUDIENCE: Patient, Health Professional, Pharmacy
ISSUE: FDA is requiring drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder (OUD) to add new recommendations about naloxone to the prescribing information. This will help ensure that health care professionals discuss the availability of naloxone and assess each patient's need for a naloxone prescription when opioid pain relievers or medicines to treat OUD are being prescribed or renewed. The patient Medication Guides, available at: https://bit.ly/3hzDavc, will also be updated.
BACKGROUND: Opioid pain relievers are medicines that can help manage pain when other treatments and medicines are not able to provide enough pain relief. Certain opioids are also used to treat OUD. Opioids have serious risks, including misuse and abuse, addiction, overdose, and death. Naloxone can help reverse opioid overdose to prevent death.
The misuse and abuse of illicit and prescription opioids and the risks of addiction, overdose, and death are a public health crisis in the United States. As a result, FDA is committed to encouraging health care professionals to raise awareness of the availability of naloxone when they are prescribing and dispensing opioid pain relievers or medicines to treat OUD. FDA held discussions about naloxone availability with the Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management Advisory Committees, available at: https://bit.ly/3hx8tXG, which recommended that all patients being prescribed opioids for use in the outpatient setting would benefit from a conversation with their health care professional about the availability of naloxone.
- Talk to your health care professionals about the benefits of naloxone and how to obtain it.
- Recognize the signs and symptoms of a possible opioid overdose. These include slowed, shallow, or difficult breathing, severe sleepiness, or not being able to respond or wake up. If you know or think someone is overdosing, give the person naloxone if you have access to it, and always call 911 or go to an emergency room right away. Naloxone is a temporary treatment, so repeat doses may be required. Even if you give naloxone, you still need to get emergency medical help right away.
- If you have naloxone, make sure to tell your caregivers, household members, and other close contacts that you have it, where it is stored, and how to properly use it in the event of an overdose. When using opioid medicines away from home, carry naloxone with you and let those you are with know you have it, where it is, and how to use it. Read the Patient Information leaflet or other educational material and Instructions for Use that comes with your naloxone because it explains important information, including how to use the medicine.
Health Care Professionals:
- Discuss the availability of naloxone with all patients when prescribing or renewing an opioid analgesic or medicine to treat OUD.
- Consider prescribing naloxone to patients prescribed medicines to treat OUD and patients prescribed opioid analgesics who are at increased risk of opioid overdose.
- Consider prescribing naloxone when a patient has household members, including children, or other close contacts at risk for accidental ingestion or opioid overdose.
- Additionally, even if the patients are not receiving a prescription for an opioid analgesic or medicine to treat OUD, consider prescribing naloxone to them if they are at increased risk of opioid overdose.
- Educate patients and caregivers on how to recognize respiratory depression and how to administer naloxone. Inform them about their options for obtaining naloxone as permitted by their individual state, available at: https://www.usa.gov/state-health, dispensing and prescribing requirements or guidelines for naloxone. Emphasize the importance of calling 911 or getting emergency medical help right away, even if naloxone is administered.
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Fentanyl patches may be habit forming, especially with prolonged use. Use the fentanyl patch exactly as directed. Do not apply more patches, apply the patches more often, or use the patches in a different way than prescribed by your doctor. While using fentanyl patches, discuss with your health care provider your pain treatment goals, length of treatment, and other ways to manage your pain. Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications, or if you have or have ever had depression or another mental illness. There is a greater risk that you will overuse fentanyl patches if you have or have ever had any of these conditions. Talk to your health care provider immediately and ask for guidance if you think that you have an opioid addiction or call the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline at 1-800-662-HELP.
Fentanyl patches may cause serious or life-threatening breathing problems, especially during the first 24 to 72 hours of your treatment and any time your dose is increased. Your doctor will monitor you carefully during your treatment. Because of this serious risk, fentanyl patches should only be used to treat people who are tolerant (used to the effects of the medication) to opioid medications because they have taken this type of medication for at least one week and should not be used to treat mild or moderate 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. Tell your doctor if you have or have ever had slowed breathing or asthma. Your doctor will probably tell you not to use fentanyl patches. Also tell your doctor if you have or have ever had lung disease such as chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways), a head injury, or any condition that increases the amount of pressure in your brain. The risk that you will develop breathing problems may be higher if you are an older adult or are weak or malnourished due to disease. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: slowed breathing, long pauses between breaths, or shortness of breath.
Taking certain medications with fentanyl may increase the risk of serious or life-threatening breathing problems, sedation, or coma. Tell your doctor and pharmacist if you are taking or plan to take any of the following medications: amiodarone (Nexterone, Pacerone); aprepitant (Emend); benzodiazepines such as alprazolam (Xanax), chlordiazepoxide (Librium), clonazepam (Klonopin), diazepam (Diastat, Valium), estazolam, flurazepam, lorazepam (Ativan), oxazepam, temazepam (Restoril), and triazolam (Halcion);carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril); certain antifungals such as fluconazole (Diflucan), itraconazole (Onmel, Sporanox), and ketoconazole (Nizoral); clarithromycin (Biaxin, in Prevpac); diltiazem (Cardizem, Cartia, Diltzac, Taztia); erythromycin (E-Mycin, Erythrocin); fosamprenavir (Lexiva); medications for mental illness and nausea; other medications for pain; muscle relaxants; nefazodone; nelfinavir (Viracept); phenytoin (Dilantin, Phenytek); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); ritonavir (Norvir, in Kaletra); sedatives; sleeping pills; tranquilizers; troleandomycin (TAO) (not available in the United States); and verapamil (Calan, Covera, Verelan). Your doctor may need to change the dosages of your medications and will monitor you carefully. If you use fentanyl with any of these medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care immediately: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own. If you use fentanyl with any of these medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.
Drinking alcohol, taking prescription or nonprescription medications that contain alcohol, or using street drugs during your treatment with fentanyl increases the risk that you will experience these serious, life-threatening side effects. Do not drink alcohol, take prescription or nonprescription medications that contain alcohol, or use street drugs during your treatment.
Do not allow anyone else to use your medication. Fentanyl patches may harm or cause death to other adults and children who use them. Store fentanyl patches in a safe place so that no one else can use them accidentally or on purpose. Be especially careful to keep fentanyl patches out of the reach of children. Keep track of how many patches are left so you will know if any are missing.
People who are not being treated with fentanyl patches may be seriously harmed or may die if the sticky side of a patch touches their skin. Be careful not to allow the sticky side of the patch to touch anyone else's skin. If you are holding or caring for children, make sure that they do not touch your patch. If the patch accidentally comes off of your body and sticks to another person's skin, immediately remove the patch, wash the area with clear water, and get emergency medical attention.
Fentanyl patches that have been worn for 3 days still contain enough medication to cause serious harm or death to adults or children who are not being treated with the medication. Never throw used or unused patches in a trash can or leave them in a place where they may be found by others, especially children. Dispose of used and unwanted patches properly according to instructions. (See STORAGE and DISPOSAL.)
If your fentanyl patch is exposed to extreme heat, it may release too much medication into your body at once. This can cause serious or life-threatening symptoms. Do not expose your patch or the skin around it to direct heat such as heating pads, electric blankets, heat lamps, saunas, hot tubs, and heated water beds. Do not take long, hot baths or sunbathe while you are wearing the patch. Your patch may also release too much medication if you have a fever or if you get very hot after physical activity. Avoid physical activity that might cause you to get very hot. Call your doctor right away if you have a fever. Your doctor may need to adjust your dose.
Tell your doctor if you are pregnant or plan to become pregnant. If you use fentanyl patches regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth. Tell your baby's doctor right away if your baby experiences any of the following symptoms: irritability, hyperactivity, abnormal sleep, high-pitched cry, uncontrollable shaking of a part of the body, vomiting, diarrhea, or failure to gain weight.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with fentanyl patches and each time you fill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risks of using this medication.
Why is this medication prescribed?
Fentanyl patches are used to relieve severe pain in people who are expected to need pain medication around the clock for a long time and who cannot be treated with other medications. Fentanyl is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.
How should this medicine be used?
Transdermal fentanyl comes as a patch to apply to the skin. The patch is usually applied to the skin once every 72 hours. Change your patch at about the same time of day every time you change it. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Apply fentanyl patches exactly as directed.
Your doctor may start you on a low dose fentanyl patch and gradually increase your dose, not more often than once every 3 days at first, and then not more often than once every 6 days. Your doctor may decrease your dose if you experience side effects. Talk to your doctor about how you are feeling during your treatment with fentanyl patches.
Fentanyl patches are only for use on the skin. Do not place patches in your mouth or chew or swallow the patches.
Do not stop using fentanyl patches without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop using fentanyl patches you may have symptoms of withdrawal. Call your doctor if you experience any of these symptoms of withdrawal: restlessness, teary eyes, runny nose, yawning, sweating, chills, muscle pain, large pupils (black circles in the center of the eyes), irritability, anxiety, backache, pain in the joints, weakness, stomach cramps, difficulty falling asleep or staying asleep, nausea, loss of appetite, vomiting, diarrhea, fast heartbeat, or rapid breathing.
Do not use a fentanyl patch that is cut, damaged, or changed in any way. If you use cut or damaged patches, you may receive most or all of the medication at once, instead of slowly over 3 days. This may cause serious problems, including overdose and death.
You may bathe, swim, or shower while you are wearing a fentanyl patch. If the patch falls off during these activities, dispose of it properly. Then dry your skin completely and apply a new patch. Leave the new patch in place for 72 hours after you apply it.
You can apply a fentanyl patch to your chest, back, upper arms, or the sides of your waist. If you are applying the patch to a child or to a person who is unable to think clearly, choose an area on the upper back to make it more difficult for the person to remove the patch and place it in his or her mouth. Choose an area of skin that is flat and hairless. Do not apply the patch to parts of the body that move a lot or to skin that has been exposed to radiation or that is sensitive, very oily, broken out, irritated, broken, cut or damaged. If there is hair on the skin, use scissors to clip the hair as close to the skin as possible. Do not shave the area.
To apply the patch, follow these steps:
- Clean the area where you plan to apply the patch with clear water and pat completely dry. Do not use any soaps, lotions, alcohols, or oils.
- Tear open the pouch containing the fentanyl patch along the dotted line, starting at the slit. Remove the patch from the pouch and peel off both parts of the protective liner from the back of the patch. Try not to touch the sticky side of the patch.
- Immediately press the sticky side of the patch onto the chosen area of skin with the palm of your hand.
- Press the patch firmly for at least 30 seconds. Be sure that the patch sticks well to your skin, especially around the edges.
- If the patch does not stick well or comes loose after it is applied, tape the edges to your skin with first aid tape. If the patch still does not stick well, you may cover it with Bioclusive or Tegaderm brand see-through dressings. Do not cover the patch with any other type of bandage or tape.
- If a patch falls off before it is time to remove it, dispose of the patch properly and apply a new patch. Leave the new patch in place for 72 hours.
- When you are finished applying the patch, wash your hands with water right away.
- When it is time to change your patch, peel off the old patch and apply a new patch to a different skin area.
- After you remove your patch, fold it in half with the sticky sides together and flush it down a toilet.
Other uses for this medicine
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before using fentanyl patches,
- tell your doctor and pharmacist if you are allergic to fentanyl, or any other medications, or any of the ingredients in fentanyl patches. Ask your doctor or pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING and any of the following medications: antidepressants; antihistamines (found in cough, cold, and allergy medications); buprenorphine (Buprenex, Subutex, in Suboxone); butorphanol; dextromethorphan (found in many cough medications; in Nuedexta); lithium (Lithobid); medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Alsuma, Imitrex, in Treximet), and zolmitriptan (Zomig); mirtazapine (Remeron); nalbuphine; pentazocine (Talwin); sedatives; 5HT3 serotonin blockers such as alosetron (Lotronex), dolasetron (Anzemet), granisetron (Kytril), ondansetron (Zofran, Zuplenz), or palonosetron (Aloxi); selective serotonin-reuptake inhibitors such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Prozac, Pexeva), and sertraline (Zoloft); serotonin and norepinephrine reuptake inhibitors such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), milnacipran (Savella), and venlafaxine (Effexor);trazodone (Oleptro); or tricyclic antidepressants ('mood elevators') such as amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil). Also tell your doctor or pharmacist if you are taking or receiving the following medications or have stopped taking them within the past 2 weeks: monoamine oxidase (MAO) inhibitors including isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate). Many other medications may also interact with fentanyl, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor what herbal products you are taking, especially St. John's wort and tryptophan.
- tell your doctor if you have or have ever had paralytic ileus (condition in which digested food does not move through the intestines). Your doctor may tell you not to use fentanyl patches.
- tell your doctor if you have or have ever had seizures; slowed heartbeat; difficulty urinating; low blood pressure; or thyroid, heart, liver, pancreas, gallbladder, or kidney disease.
- tell your doctor if you are breastfeeding.
- you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of using fentanyl transdermal patch.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are using fentanyl patches.
- you should know that this medication may make you drowsy. Do not drive a car, operate machinery, or do other possibly dangerous activities until you know how this medication affects you.
- you should know that fentanyl patches may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start using fentanyl patches. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
- you should know that fentanyl patches may cause constipation. Talk to your doctor about changing your diet or using other medications to prevent or treat constipation while you are using fentanyl patches.
What special dietary instructions should I follow?
Talk to your doctor about eating grapefruit and drinking grapefruit juice while using this medication.
What should I do if I forget a dose?
If you forget to apply or change a fentanyl patch, apply the patch as soon as you remember it. Be sure to remove your used patch before applying a new patch. Wear the new patch for the period of time prescribed by your doctor (usually 3 days) and then replace it. Do not wear two patches at once unless your doctor has told you that you should.
What side effects can this medication cause?
Fentanyl patches may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- mood changes
- feeling cold
- 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
- stomach pain
- back pain
- difficulty urinating
- skin irritation, redness, itching, or swelling in the area where you wore the patch
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:
- changes in heartbeat
- agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea
- nausea, vomiting, loss of appetite, weakness, or dizziness
- inability to get or keep an erection
- irregular menstruation
- decreased sexual desire
- chest pain
- swelling of the eyes, face, mouth, tongue, throat, arms, hands, feet, ankles, or lower legs
- difficulty breathing or swallowing
Fentanyl patches may cause other side effects. Call your doctor if you have any unusual problems while you are using fentanyl patches.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I know about storage and disposal of this medication?
Store the fentanyl patches at room temperature and away from excess heat and moisture (not in the bathroom).
You must immediately dispose of any used or unused patches that are outdated or no longer needed through a medicine take-back program. If you do not have a take-back program nearby or one that you can access promptly, then throw away any patches by first carefully removing the adhesive backing, folding the sticky sides of each patch together so that it sticks to itself, and then flushing the folded patches down the toilet. Dispose of the pouches and protective liners in the trash. Wash your hands well with water after throwing away fentanyl patches. Do not put unneeded or used fentanyl patches in a garbage can.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org
In case of emergency/overdose
In case of overdose, remove the fentanyl patch from the victim's skin and call local emergency services at 911.
While you are using fentanyl patches, you may be told to always have a rescue medication called naloxone available (e.g., home, office). Naloxone is used to reverse the life-threatening effects of an overdose. It works by blocking the effects of opiates to relieve dangerous symptoms caused by high levels of opiates in the blood. You will probably be unable to treat yourself if you experience an opiate overdose. You should make sure that your family members, caregivers, or the people who spend time with you know how to tell if you are experiencing an overdose, how to use naloxone, and what to do until emergency medical help arrives. Your doctor or pharmacist will show you and your family members how to use the medication. Ask your pharmacist for the instructions or visit the manufacturer's website to get the instructions. If someone sees that you are experiencing symptoms of an overdose, he or she should give you your first dose of naloxone, call 911 immediately, and stay with you and watch you closely until emergency medical help arrives. Your symptoms may return within a few minutes after you receive naloxone. If your symptoms return, the person should give you another dose of naloxone. Additional doses may be given every 2 to 3 minutes, if symptoms return before medical help arrives.
Symptoms of overdose may include the following:
- difficulty breathing
- extreme sleepiness or tiredness
- difficulty thinking, talking, or walking normally
- small, pinpoint pupils (black circles in the center of the eye)
- coma (loss of consciousness for a period of time)
What other information should I know?
Keep all appointments with your doctor and laboratory. Your doctor will order certain lab tests to check your body's response to fentanyl.
Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are using fentanyl.
This prescription is not refillable. Be sure to schedule appointments with your doctor on a regular basis so that you do not run out of medication if your doctor wants you to continue using fentanyl patches.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.