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.
About your treatment
Your doctor has ordered meperidine, a strong analgesic (painkiller), to relieve your pain. The drug will be either injected into a large muscle (such as your buttock or hip) or added to an intravenous fluid that will drip through a needle or catheter placed in your vein or under your skin.
You may receive meperidine continuously for around-the-clock pain relief. Your doctor also may order other pain medications to make you more comfortable. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Your health care provider (doctor, nurse, or pharmacist) may measure the effectiveness and side effects of your treatment using laboratory tests and physical examinations. It is important to keep all appointments with your doctor and the laboratory. The length of treatment depends on how you respond to the medication.
Before administering meperidine,
- tell your doctor and pharmacist if you are allergic to meperidine or any other drugs.
- tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially other pain relievers; antidepressants; cough, cold, and allergy products; MAO inhibitors [phenelzine (Nardil) or tranylcypromine (Parnate)]; sedatives; sleeping pills; tranquilizers; and vitamins.
- tell your doctor if you have or have ever had liver or kidney disease, a history of alcoholism, lung or thyroid disease, heart disease, seizures, prostatic hypertrophy, or urinary problems.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking meperidine, call your doctor.
- talk to your doctor about the risks and benefits of receiving meperidine if you are 65 years of age or older. Older adults should not usually receive meperidine because it is not as safe as other medications that can be used to treat the same condition.
- you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
- remember that alcohol can add to the drowsiness caused by this drug.
Administering your medication
Before you administer meperidine, look at the solution closely. It should be clear and free of floating material. Gently squeeze the bag or observe the solution container to make sure there are no leaks. Do not use the solution if it is discolored, if it contains particles, or if the bag or container leaks. Use a new solution, but show the damaged one to your health care provider.
It is important that you use your medication exactly as directed. Meperidine can be habit forming. Do not administer it more often or for a longer period than your doctor tells you. Do not change your dosing schedule without talking to your health care provider. Your health care provider may tell you to stop your infusion if you have a mechanical problem (such as a blockage in the tubing, needle, or catheter); if you have to stop an infusion, call your health care provider immediately so your therapy can continue.
Meperidine may cause side effects. Tell your health care provider if any of these symptoms are severe or do not go away:
- mood changes
- upset stomach
- difficulty urinating
If you experience any of the following symptoms, call your health care provider immediately:
- difficulty breathing
- muscle twitching
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).
Storing your medication
- Your health care provider probably will give you a several-day supply of meperidine at a time. If you are receiving meperidine intravenously (in your vein), you probably will be told to store it in the refrigerator.
- Take your next dose from the refrigerator 1 hour before using it; place it in a clean, dry area to allow it to warm to room temperature.
If you are receiving meperidine intramuscularly (in your muscle), your health care provider will tell you how to store it properly.
Store your medication only as directed. Make sure you understand what you need to store your medication properly.
Keep your supplies in a clean, dry place when you are not using them, and keep all medications and supplies out of reach of children. Your health care provider will tell you how to throw away used needles, syringes, tubing, and containers to avoid accidental injury.
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.
Signs of infection
If you are receiving meperidine in your vein or under your skin, you need to know the symptoms of a catheter-related infection (an infection where the needle enters your vein or skin). If you experience any of these effects near your intravenous catheter, tell your health care provider as soon as possible:
- Demerol® Injection