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.
Hydromorphone rectal may be habit forming, especially with prolonged use. Use hydromorphone rectal exactly as directed. Do not use a larger dose, use it more often, or use it for a longer period of time or in a different way than prescribed by your doctor. While you are using hydromorphone rectal, 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 hydromorphone rectal 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.
Taking certain medications during your treatment with hydromorphone rectal may increase the risk that you will develop serious or life-threatening breathing problems, sedation, or coma. Tell your doctor if you are taking or plan to take any of the following medications: benzodiazepines such as alprazolam (Xanax), chlordiazepoxide (Librium), clonazepam (Klonopin), diazepam (Diastat, Valium), estazolam, flurazepam, lorazepam (Ativan), oxazepam, temazepam (Restoril), and triazolam (Halcion); medications for mental illness or nausea; muscle relaxants; other pain medications; sedatives; sleeping pills; or tranquilizers. Your doctor may need to change the doses of your medications and will monitor you carefully. If you use hydromorphone rectal 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 hydromorphone rectal 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.
Talk to your doctor about the risks of using hydromorphone rectal.
Why is this medication prescribed?
Hydromorphone suppositories are used to relieve moderate to severe pain. Hydromorphone 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?
Hydromorphone comes as a suppository to insert in the rectum. It is inserted usually once every 6 to 8 hours. Insert hydromorphone at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use hydromorphone suppositories exactly as directed.
Do not stop using hydromorphone suppositories without talking to your doctor. If you suddenly stop using hydromorphone suppositories, you may experience withdrawal symptoms including restlessness, teary eyes, runny nose, yawning, sweating, chills, hair standing on end, muscle and joint pain, widening of the pupils (black circles in the middle of the eyes), irritability, anxiety, backache, weakness, stomach cramps, difficulty falling asleep or staying asleep, nausea, loss of appetite, vomiting, diarrhea, fast breathing, or fast heartbeat. Your doctor will probably decrease your dose gradually.
To use the suppositories, follow these steps:
- Remove the wrapper.
- Dip the tip of the suppository in water.
- Lie down on your left side and raise your right knee to your chest (a left-handed person should lie on the right side and raise the left knee).
- Using your finger, insert the suppository about 1 inch (2.5 centimeters) into the rectum.
- Hold it in place with your finger for a few moments.
- Stand up after about 15 minutes. Wash your hands thoroughly and resume normal activities.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before using hydromorphone suppositories,
- tell your doctor and pharmacist if you are allergic to hydromorphone, any other medications, or any of the ingredients in hydromorphone suppositories. Ask your pharmacist for a list of the ingredients.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: cyclobenzaprine (Amrix); dextromethorphan (found in many cough medications; in Nuedexta); lithium (Lithobid, in Librax); medications for seizures medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, in Treximet), and zolmitriptan (Zomig); mirtazapine (Remeron); narcotic medications for pain other than hydromorphone; 5HT3 serotonin blockers such as alosetron (Lotronex), dolasetron (Anzemet), granisetron (Sancuso, Sustol), ondansetron (Zofran, Zuplenz), or palonosetron (Aloxi, in Akynzeo); 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; and tricyclic antidepressants ('mood elevators') such as amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil). Also tell your doctor or pharmacist if you are taking or receiving the following monoamine oxidase (MAO) inhibitors or if you have stopped taking them within the past two weeks: isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). Many other medications may also interact with hydromorphone, 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 or tryptophan.
- tell your doctor if you have or have ever had a head injury or any condition that caused damage to your brain, any condition that increases the pressure in your brain; slowed breathing; or any condition that affects your breathing such as asthma, chronic obstructive pulmonary disease (COPD; a group of diseases including chronic bronchitis and emphysema that affect the lungs and airways), or kyphoscoliosis (curving of the spine that may cause breathing problems). Your doctor may tell you not to use hydromorphone suppositories.
- tell your doctor if you are an older adult or if you are weakened or malnourished by disease. Also tell your doctor if you have or have ever had hypothyroidism (condition in which the thyroid gland produces less hormone than normal); Addison's disease (condition in which the adrenal gland produces less hormone than normal); any condition that causes difficulty urinating such as an enlarged prostate (a male reproductive gland) or urethral stricture (blockage of the tube that allows urine to leave the body); or liver or kidney disease.
tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using hydromorphone suppositories, call your doctor.
- you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of using hydromorphone suppositories.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are using hydromorphone suppositories.
- you should know that hydromorphone may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
- you should know that hydromorphone 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 hydromorphone suppositories. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
Use the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.
What side effects can this medication cause?
Hydromorphone suppositories may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- mood changes
- difficulty urinating
- narrowing of the pupils (dark circles in the center of the eyes)
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:
- slowed or stopped breathing
- breathing that is irregular or that stops and starts
- 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
Hydromorphone suppositories may cause other side effects. Call your doctor if you have any unusual problems while you are using this medication.
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?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in the refrigerator. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
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
Store hydromorphone suppositories in a refrigerator in a safe place so that no one else can take the medication accidentally or on purpose. Keep track of how many suppositories are left so you will know if any are missing.
In case of emergency/overdose
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
While you are using hydromorphone rectal, 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:
- slowed or stopped breathing
- coma (loss of consciousness for a period of time)
- muscle weakness
- cold, clammy skin
- narrowing or widening of the pupils (dark circle in the middle of the eye)
- slowed or stopped heartbeat
What other information should I know?
Keep all appointments with your doctor and laboratory. Your doctor may order certain lab tests to check your body's response to hydromorphone.
Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are using hydromorphone.
This prescription is not refillable. If you continue to have pain after you finish the hydromorphone suppositories, call your doctor.
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.
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