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.
Tapentadol may cause serious or life-threatening breathing problems, especially at the beginning of your treatment and any time your dose is increased. 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 tapentadol. Also tell your doctor if you have or have ever had lung disease such as chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema), 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 other medications during your treatment with tapentadol may increase the risk that you will experience breathing problems or other serious, life threatening side effects. Tell your doctor if you are taking or plan to take any of the following medications: other narcotic pain medications; medications for mental illness or nausea; muscle relaxants; sedatives; sleeping pills; or tranquilizers.
Drinking alcohol, taking prescription or nonprescription medications that contain alcohol, or using street drugs during your treatment with tapentadol increases the risk that you will experience serious, life-threatening side effects. Do not drink alcohol, take prescription or non-prescription medications that contain alcohol, or use street drugs during your treatment with tapentadol.
Tapentadol 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 tapentadol if you have or have ever had any of these conditions.
Do not allow anyone else to take your medication. Tapentadol may harm or cause death to other people who take your medication, especially children. Keep tapentadol in a safe place so that no one else can take it accidentally or on purpose. Be especially careful to keep tapentadol out of the reach of children. Keep track of how many tablets or extended-release tablets are left so you will know if any medication is missing. Flush any tablets or extended-release tablets that are outdated or no longer needed down the toilet so that others will not take them.
If you are taking the extended-release tablets, swallow them whole; do not chew, break, divide, crush, or dissolve them. If you swallow broken, chewed, crushed, or dissolved extended-release tablets, you may receive too much tapentadol at once instead of slowly over 12 hours. This may cause serious problems, including overdose and death.
Tell your doctor if you are pregnant or plan to become pregnant. If you take tapentadol 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.
Talk to your doctor about the risks of taking tapentadol.
If you are taking tapentadol 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.
Why is this medication prescribed?
Tapentadol tablets are used to treat moderate to severe acute pain (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed). Tapentadol extended-release tablets are used to treat severe neuropathic pain (pain caused by nerve damage) in people who have diabetes. Tapentadol extended-release tablets are only used to treat people who are expected to need medication around-the-clock to relieve pain that cannot be controlled by the use of other pain medications. Tapentadol 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?
Tapentadol comes as a tablet and an extended-release (long acting) tablet to take by mouth. The tablets are usually taken with or without food every 4 to 6 hours as needed. If you are taking tapentadol tablets, your doctor may tell you that you may take a second dose as soon as 1 hour after the first dose on your first day of treatment if needed to treat your pain. Do not take extra doses at any other time during your treatment and do not ever take extra doses of the extended-release tablets. The extended-release tablets are taken once every 12 hours. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take tapentadol exactly as directed.
If you are taking the extended-release tablets, swallow them one at a time with plenty of water. Swallow each tablet right after you put it in your mouth.
Your doctor will probably start you on a low dose of tapentadol and gradually increase your dose until your pain is controlled. Your doctor may adjust your dose at any time during your treatment if your pain is not controlled. If you feel that your pain is not controlled, call your doctor. Do not change the dose of your medication without talking to your doctor.
After you take tapentadol for a period of time, your body may become used to the medication. If this happens, your doctor may need to increase your dose of medication to control your pain. Talk to your doctor about how you are feeling during your treatment with tapentadol.
Do not stop taking tapentadol without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking tapentadol, you may experience withdrawal symptoms such as restlessness; anxiety; irritability; teary eyes; yawning; chills; sweating; difficulty falling asleep or staying asleep; shivering; uncontrollable shaking of a part of your body; muscle, back, or joint pain; weakness; nausea; vomiting; diarrhea; stomach cramps; loss of appetite; runny nose, sneezing, or coughing; hair on your skin standing on end; fast breathing; fast heartbeat; widening of the pupils (black circles in the middle of the eyes); or hallucinations (seeing things or hearing voices that do not exist).
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 tapentadol,
- tell your doctor and pharmacist if you are allergic to tapentadol, or any other medications, or any of the ingredients in tapentadol tablets or extended-release tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor if you are taking the following medications or have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Emsam, Eldepryl, Zelapar), and tranylcypromine (Parnate). Also tell your doctor if any of these medications are prescribed for you during your treatment with tapentadol. Your doctor will probably tell you not to take tapentadol if you are taking one or more of these medications.
- tell your doctor and pharmacist what other 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: antidepressants such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Surmontil, Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); antihistamines (in cough, cold, and allergy medications); buprenorphine (Buprenex, Subutex, in Suboxone, in Zubsolv); butorphanol; medications for irritable bowel disease, motion sickness, Parkinson's disease, ulcers, or urinary problems;medications for migraines 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); selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Selfemra, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft); selective serotonin/norepinephrine reuptake inhibitors (SNRIs) such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), and venlafaxine (Effexor); tramadol (Conzip, Ultram, in Ultracet); and trazodone (Oleptro). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or paralytic ileus (condition in which digested food does not move through the intestines). Your doctor may tell you not to take tapentadol.
- tell your doctor if you have or have ever had , a blockage in your stomach or intestines,any condition that causes difficulty urinating; or pancreas, gallbladder, kidney, thyroid, or liver disease.
- tell your doctor if you are breastfeeding.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking tapentadol.
- you should know that tapentadol may make you drowsy. Do not drive a car, operate machinery, or participate in any other possibly dangerous activities until you know how this medication affects you.
- you should know that tapentadol 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 tapentadol may cause constipation. Talk to your doctor about changing your diet or using other medications to prevent or treat constipation while you are taking tapentadol.
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 tapentadol tablets, your doctor will probably tell you to take the medication as needed. If your doctor has told you to take the tablets regularly, take the missed dose as soon as you remember it. Do not take a double dose to make up for a missed one.
If you are taking tapentadol extended-release capsules, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Tapentadol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- loss of appetite
- stomach pain
- dry mouth
- excessive tiredness
- difficulty falling asleep or staying asleep
- abnormal dreams
- sudden feeling of warmth
- increased sweating
Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS or IMPORTANT WARNING sections, call your doctor immediately or get emergency medical treatment:
- swelling of the eyes, face, lips, tongue, or throat
- difficulty breathing or swallowing
- chest pain
- feeling lightheaded when you change positions
- feeling faint
- hallucinations (seeing things or hearing voices that are not there)
- loss of consciousness
- feeling overheated
- heavy sweating
Tapentadol 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 the following:
- narrowing or widening of the pupils (dark circles in the eyes)
- loss of consciousness or coma
- muscle weakness
- cold, clammy skin
- slowed or stopped breathing
- slowed heartbeat
What other information should I know?
Keep all appointments with your doctor.
This prescription is not refillable. If you continue to have pain after you finish the medication, 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.
- Nucynta® ER