AUDIENCE: Family Practice, Psychiatry, Pain Management, Nursing, Endocrinology
ISSUE: FDA is warning about several safety issues with the entire class of opioid pain medicines. See the http://www.fda.gov/Drugs/DrugSafety/ucm489676.htm for a complete listing. These safety risks are potentially harmful interactions with numerous other medications, problems with the adrenal glands, and decreased sex hormone levels. We are requiring changes to the labels of all opioid drugs to warn about these risks.
BACKGROUND: Opioids are powerful prescription medicines that can help manage pain when other treatments and medicines are not able to provide enough pain relief (see List of Opioid Medicines in the http://www.fda.gov/Drugs/DrugSafety/ucm489676.htm). However, opioids also carry serious risks, including of misuse and abuse, addiction, overdose, and death.
Prescription opioids are divided into two main categories – immediate-release (IR) products, usually intended for use every 4 to 6 hours; and extended release/long acting (ER/LA) products, intended to be taken once or twice a day, depending on the individual product and patient.
See the http://www.fda.gov/Drugs/DrugSafety/ucm489676.htm for additional information, including a listing of opioids, serotonergic medicines, and a data summary.
Health care professionals should discontinue opioid treatment and/or use of the other medicine if serotonin syndrome is suspected.
Health care professionals should perform diagnostic testing if adrenal insufficiency is suspected. If diagnosed, treat with corticosteroids and wean the patient off of the opioid, if appropriate. If the opioid can be discontinued, follow-up assessment of adrenal function should be performed to determine if treatment with corticosteroids can be discontinued.
Decreased sex hormone levels:
Health care professionals should conduct laboratory evaluation in patients presenting with such signs or symptoms.
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Hydromorphone may cause serious or life-threatening breathing problems, especially during the first 72 hours of your treatment and any time your dose is increased. Your doctor will monitor you carefully during your treatment. Tell your doctor if you have slowed breathing or have or have ever had asthma. Your doctor will probably tell you not to take hydromorphone. Also tell your doctor if you have or have ever had lung disease such as chronic obstructive pulmonary disease (a group of diseases that affect the lungs and airways), a head injury or any condition that increases the pressure in your brain. or kyphoscoliosis (curving of the spine that may cause breathing problems). 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 other medications during your treatment with hydromorphone may increase the risk that you will experience serious, life-threatening side effects. Tell your doctor if you are taking or plan to take any of the following medications: antidepressants, other narcotic pain medications; medications for anxiety, nausea, or mental illness; muscle relaxants; sedatives; sleeping pills; or tranquilizers. Your doctor may need to change the doses of your medications and will monitor you carefully.
Drinking alcohol, taking prescription or non-prescription medications that contain alcohol, or using street drugs during your treatment with hydromorphone increases the risk that you will experience serious, life-threatening side effects. Talk to your doctor about the risks of drinking alcohol or using street drugs during your treatment.
Swallow the extended-release tablets whole. Do not split, chew, dissolve, or crush them. If you swallow broken, chewed, crushed, or dissolved tablets you may receive too much hydromorphone at once instead of receiving the medication slowly over time. This may cause serious breathing problems or death.
Hydromorphone may be habit-forming. Do not take more of it, take it more often, or take it in a different way than directed by your doctor. 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 if you have or have ever had any of these conditions.
Do not allow anyone else to take your medication. Hydromorphone may harm or cause death to other people who take your medication, especially children. Keep hydromorphone in a safe place so that no one else can take it accidentally or on purpose. Be especially careful to keep hydromorphone out of the reach of children. Keep track of how many tablets or how much liquid is left so you will know if any medication is missing. Dispose of unwanted tablets, extended-release tablets, and liquid properly according to instructions. (See STORAGE and DISPOSAL.)
Tell your doctor if you are pregnant or plan to become pregnant. If you take hydromorphone 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.
If you are taking hydromorphone extended-release tablets, your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin your treatment 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 taking hydromorphone.
Why is this medication prescribed?
Hydromorphone is used to relieve pain. Hydromorphone extended-release tablets 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. Hydromorphone extended-release tablets 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. 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 liquid, a tablet, and an extended-release (long-acting) tablet to take by mouth. The liquid is usually taken every 3 to 6 hours and the tablets are usually taken every 4 to 6 hours. The extended-release tablets are taken once daily with or without food. Take hydromorphone 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 hydromorphone exactly as directed.
Your doctor may start you on a low dose of hydromorphone and gradually increase your dose, not more often than once every 3 to 4 days. Your doctor may decrease your dose if you experience side effects. Tell your doctor if you feel that your pain is not controlled or if you experience side effects during your treatment with hydromorphone. Do not change the dose of your medication without talking to your doctor.
Do not stop taking hydromorphone without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking hydromorphone, you may experience withdrawal symptoms including restlessness, teary eyes, runny nose, yawning, sweating, chills, hair standing on end, muscle or 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. If you do not take hydromorphone extended-release tablets for longer than 3 days for any reason, talk to your doctor before you start taking the medication again.
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 hydromorphone,
- tell your doctor and pharmacist if you are allergic to hydromorphone, any other medications, sulfites, or any of the ingredients in hydromorphone tablets, solution, 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, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: buprenorphine (Buprenex, Butrans, in Suboxone, in Zubsolv); butorphanol; ipratropium (Atrovent); medications for glaucoma, irritable bowel disease, Parkinson's disease, ulcers, and urinary problems; nalbuphine; and pentazocine (Talwin). Also tell your doctor or pharmacist if you are taking any of the following medications or have stopped taking them within the past two weeks: isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have any of the conditions listed in the IMPORTANT WARNING section or paralytic ileus (condition in which food does not move through the intestines), or a blockage in the stomach or intestines. Your doctor may tell you not to take hydromorphone.
- if you will be taking the extended-release tablets, also tell your doctor if you have ever had surgery that caused a change in the way food moves through your stomach or intestines or if you have any condition that cause narrowing of the esophagus (tube that carries food from the mouth to the stomach), stomach, or intestines such as cystic fibrosis (a condition that causes the body to produce thick, sticky mucus that may clog the pancreas, lungs, and other parts of the body), peritonitis (inflammation of the lining of the abdomen (stomach area), Meckel's diverticulum (a bulge in the lining of the small intestine that is present at birth), chronic intestinal pseudo-obstruction (condition in which the muscles in the intestine do not move food smoothly through the intestine), or inflammatory bowel disease (IBD; a group of conditions that cause inflammation of the lining of the intestine. Your doctor may tell you not to take hydromorphone extended-release tablets.
- tell your doctor if you have or have ever had low blood pressure;Addison's disease (condition in which the adrenal gland produces less hormone than normal); seizures; 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 gallbladder, pancreas, liver, thyroid, or kidney disease.
tell your doctor if you are breast-feeding.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking hydromorphone.
- 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. 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 hydromorphone may cause constipation. Talk to your doctor about changing your diet or using other medications to prevent or treat constipation while you are taking hydromorphone.
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?
If you are taking the tablets or solution, take 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 take a double dose to make up for a missed one.
If you are taking the extended-release tablets, skip the missed dose and continue your regular dosing schedule. Do not take more than one dose of the extended-release tablets in 24 hours.
What side effects can this medication cause?
Hydromorphone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- difficulty falling asleep or staying asleep
- loss of appetite
- dry mouth
- heavy sweating
- muscle, back or joint pain
- stomach pain
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 or get emergency medical treatment:
- swelling of the eyes, face, lips, tongue, mouth, throat, arms, hands, feet, ankles, or lower legs
- difficulty breathing or swallowing
- chest pain
- extreme drowsiness
- lightheadedness when changing positions
Hydromorphone may cause other side effects. Call your doctor if you have any unusual problems while you are 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). Flush any medication that is outdated or no longer needed down the toilet. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- 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 circles in the middle of the eyes)
- slowed or stopped heartbeat
What other information should I know?
Keep all appointments with your doctor.
If you are taking the extended-release tablet and you have any x-ray tests, tell the technician that you are taking this medication.
This prescription is not refillable. If you continue to have pain after you finish the hydromorphone, call your doctor.
If you are taking the extended release tablets, you may see the tablet shell in your stool. This is normal and does not mean that you did not receive the full dose of medication.
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.