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.
Hydrocodone can be habit forming, especially with prolonged use. Take hydrocodone exactly as directed. Do not take more of it, take it more often, or take it in a different way than directed by your doctor. While taking hydrocodone, 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 hydrocodone 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.
Do not allow anyone else to take your medication. Hydrocodone may harm or cause death to other people who take your medication, especially children. Keep hydrocodone in a safe place so that no one else can take it accidentally or on purpose. Be especially careful to keep hydrocodone out of the reach of children. Keep track of how many capsules or tablets are left so you will know if any medication is missing.
Hydrocodone may cause slowed or stopped breathing, 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. Your doctor will adjust your dose to control your pain and decrease the risk that you will experience serious breathing problems. Tell your doctor if you have or have ever had slowed breathing or asthma. Your doctor will probably tell you not to take hydrocodone. 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 weakened 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 or stopping treatment with certain other medications while you are taking hydrocodone may increase the risk that you will experience breathing problems, sedation, coma, or other serious, life-threatening side effects. Tell your doctor if you are taking, plan to take or plan to stop taking any of the following medications: certain antifungal medications including itraconazole (Onmel, Sporanox), ketoconazole (Extina, Nizoral, Xolegel), and voriconazole (Vfend); 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, others); cimetidine; clarithromycin (Biaxin, in Prevpac); erythromycin (E.E.S., Erythromycin, others); other narcotic pain medications; medications for mental illness or nausea; certain medications for human immunodeficiency virus (HIV) including ritonavir (Norvir, in Kaletra, in Viekira Pak); muscle relaxants; phenytoin (Dilantin, Phenytek); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); sedatives; sleeping pills; or tranquilizers. If you take hydrocodone 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 hydrocodone 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.
Swallow hydrocodone extended-release capsules or extended-release tablets whole; do not chew, break, divide, crush, or dissolve them. Hydrocodone extended-release capsules and extended-release tablets are difficult to crush, break or dissolve. If you swallow broken, chewed, or crushed extended-release capsules or extended-release tablets, you may receive too much hydrocodone at once. This may cause serious problems, including overdose and death.
Tell your doctor if you are pregnant or plan to become pregnant. If you take hydrocodone 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 hydrocodone and each time you refill 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 taking hydrocodone.
Why is this medication prescribed?
Hydrocodone is used to relieve severe pain. Hydrocodone is only used to treat people who are expected to need medication to relieve severe pain around-the-clock for a long time and who cannot be treated with other medications or treatments. Hydrocodone extended-release (long-acting) capsules or extended-release tablets should not be used to treat pain that can be controlled by medication that is taken as needed. Hydrocodone is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.
This monograph only includes information about the use of hydrocodone alone. If you are taking a hydrocodone combination product, be sure to read information about all the ingredients in the hydrocodone-combination monograph and ask your doctor or pharmacist for more information.
How should this medicine be used?
Hydrocodone comes as an extended-release (long-acting) capsule and an extended-release (long-acting) tablet to take by mouth. The extended-release capsule is usually taken once every 12 hours. The extended-release tablet is usually taken once daily. Take hydrocodone at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take hydrocodone exactly as directed by your doctor.
Swallow the extended-release capsules or extended-release tablets one at a time with plenty of water. Swallow each capsule or tablet as soon as you put it in your mouth. Do not presoak, wet, or lick the extended-release tablets before you put them in your mouth.
Your doctor will probably start you on a low dose of hydrocodone and may gradually increase your dose, not more than once every 3 to 7 days if needed to control your pain. After your take hydrocodone for a period of time, your body may become used to the medication. If this happens, your doctor may increase your dose of hydrocodone or may prescribe a different medication to help control your pain. Talk to your doctor about how you are feeling during your treatment with hydrocodone.
Do not stop taking hydrocodone without talking to your doctor. If you suddenly stop taking hydrocodone, you may experience withdrawal symptoms such as restlessness, teary eyes, runny nose, yawning, sweating, chills, hair standing on end, muscle pain, widened pupils (black circles in the middle of the eyes), irritability, anxiety, back or joint pain, 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.
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 taking hydrocodone,
- tell your doctor and pharmacist if you are allergic to hydrocodone, any other medications, or any of the ingredients in hydrocodone extended-release capsules or extended-release tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor and pharmacist what 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 section and any of the following medications: antihistamines (found in cough and cold medications); amiodarone (Nexterone, Pacerone); azithromycin (Zithromax, Zmax); butorphanol; chlorpromazine; citalopram (Celexa); cyclobenzaprine (Amrix); dextromethorphan (found in many cough medications; in Nuedexta); dronedarone (Multaq); haloperidol (Haldol); laxatives such as lactulose (Cholac, Constulose, Enulose, others); levofloxacin (Levaquin); lithium (Lithobid); medications for irritable bowel disease, Parkinson's disease, ulcers, and urinary problems; 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); nalbuphine; pentazocine (Talwin); 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 two weeks: isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). Many other medications may also interact with hydrocodone, 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 any of the conditions mentioned in the IMPORTANT WARNING section, a blockage or narrowing of your stomach or intestines, or paralytic ileus (condition in which digested food does not move through the intestines). Your doctor may tell you not to take hydrocodone.
- tell your doctor if you have or have ever had low blood pressure, difficulty urinating, seizures, or thyroid, gall bladder, pancreas, liver, or kidney disease. If you are taking the extended-release tablets, also tell your doctor if you have or have ever had difficulty swallowing, colon cancer (cancer that begins in the large intestine), esophageal cancer (cancer that begins in the tube that connects the mouth and stomach), heart failure (HF; condition in which the heart cannot pump enough blood to other parts of the body), or heart rhythm problems such long QT syndrome (condition that increases the risk of developing an irregular heartbeat that may cause fainting or sudden death).
- 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 taking hydrocodone.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking hydrocodone.
- you should know that hydrocodone may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
- you should know that hydrocodone may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking hydrocodone. 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 hydrocodone may cause constipation. Talk to your doctor about changing your diet and using other medications to treat or prevent constipation.
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?
Skip the missed dose and continue your regular dosing schedule. Do not take more than one dose of hydrocodone extended-release capsules in 12 hours or extended-release tablets in 24 hours.
What side effects can this medication cause?
Hydrocodone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- stomach pain
- dry mouth
- back pain
- muscle tightening
- difficult, frequent, or painful urination
- ringing in the ears
- difficulty falling asleep or staying asleep
- foot, leg, or ankle swelling
- uncontrollable shaking of a part of the body
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment:
- chest pain
- 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
- swelling of your eyes, face, lips, tongue, or throat
- changes in heartbeat
- difficulty swallowing or breathing
Hydrocodone may cause other side effects. Call your doctor if you have any unusual problems while taking 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 at room temperature and away from excess heat and moisture (not in the bathroom). You must immediately dispose of any medication that is 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, flush any hydrocodone tablets or capsules that are outdated or no longer needed down the toilet. 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
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 taking hydrocodone, 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 breathing
- muscle weakness
- cold, clammy skin
- narrowed or widened pupils
- slowed heartbeat
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 hydrocodone.
Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are taking hydrocodone.
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 hydrocodone if your doctor wants you to continue taking this medication. If you continue to have pain after you finish your hydrocodone prescription, 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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