AUDIENCE: Pharmacy, Internal Medicine, Psychiatry, Neurology, Family Practice
ISSUE: FDA review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects, including slowed or difficult breathing and deaths. Opioids are used to treat pain and cough; benzodiazepines are used to treat anxiety, insomnia, and seizures. In an effort to decrease the use of opioids and benzodiazepines, or opioids and other CNS depressants, together, FDA is adding Boxed Warnings, our strongest warnings, to the drug labeling of prescription opioid pain and prescription opioid cough medicines, and benzodiazepines. See the Drug Safety Communication, available at: http://www.fda.gov/Drugs/DrugSafety/ucm518473.htm, for a listing of all approved prescription opioid pain and cough medicines, and benzodiazepines and other CNS depressants.
FDA conducted and reviewed several studies showing that serious risks are associated with the combined use of opioids and benzodiazepines, other drugs that depress the CNS, or alcohol (see the FDA Drug Safety Communication, available at: http://www.fda.gov/Drugs/DrugSafety/ucm518473.htm, for a Data Summary). Based on these data, FDA is requiring several changes to reflect these risks in the opioid and benzodiazepine labeling, and new or revised patient Medication Guides. These changes include the new Boxed Warnings and revisions to the Warnings and Precautions, Drug Interactions, and Patient Counseling Information sections of the labeling.
FDA is continuing to evaluate the evidence regarding combined use of benzodiazepines or other CNS depressants with medication-assisted therapy (MAT) drugs used to treat opioid addiction and dependence. FDA is also evaluating whether labeling changes are needed for other CNS depressants, and will update the public when more information is available.
BACKGROUND: Opioids are powerful prescription medicines that can help manage pain when other treatments and medicines cannot be taken or are not able to provide enough pain relief. Benzodiazepines are a class of medicines that are widely used to treat conditions including anxiety, insomnia, and seizures.
RECOMMENDATION: Health care professionalsshould limit prescribing opioid pain medicines with benzodiazepines or other CNS depressants only to patients for whom alternative treatment options are inadequate. If these medicines are prescribed together, limit the dosages and duration of each drug to the minimum possible while achieving the desired clinical effect. Warn patients and caregivers about the risks of slowed or difficult breathing and/or sedation, and the associated signs and symptoms. Avoid prescribing prescription opioid cough medicines for patients taking benzodiazepines or other CNS depressants, including alcohol.
Patients taking opioids with benzodiazepines, other CNS depressant medicines, or alcohol, and caregivers of these patients, should seek medical attention immediately if they or someone they are caring for experiences symptoms of unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness.
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Why is this medication prescribed?
Oxazepam is used to relieve anxiety, including anxiety caused by alcohol withdrawal (symptoms that may develop in people who stop drinking alcohol after drinking large amounts for a long time). Oxazepam is in a class of medications called benzodiazepines. It works by slowing activity in the brain to allow for relaxation.
How should this medicine be used?
Oxazepam comes as a capsule to take by mouth. It is usually taken three or four times a day and may be taken with or without food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take oxazepam exactly as directed.
Oxazepam can be habit-forming. Do not take a larger dose, take it more often, or take it for a longer time than prescribed by your doctor. Oxazepam may not work as well if it is taken for a long time.
Oxazepam may help control your symptoms but will not cure your condition.Continue to take oxazepam even if you feel well. Do not skip doses even if you feel that you do not need them. Do not stop taking this medication without talking to your doctor. If you suddenly stop taking oxazepam, you may experience withdrawal symptoms (anxiousness, sleeplessness, and irritability). Your doctor will probably decrease your dose gradually.
Other uses for this medicine
Oxazepam is also used to treat irritable bowel syndrome. Talk to your doctor about the possible risks of using this medication for your condition.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking oxazepam,
- tell your doctor and pharmacist if you are allergic to oxazepam, any other medications, or any of the ingredients in oxazepam capsules. Ask your doctor or pharmacist for more information.
- 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: antihistamines; digoxin (Lanoxin); levodopa (Larodopa, Sinemet); medication for depression, seizures, Parkinson's disease, pain, asthma, colds, or allergies; muscle relaxants; oral contraceptives; phenytoin (Dilantin); probenecid (Benemid); rifampin (Rifadine); sedatives; sleeping pills; theophylline (Theo-Dur); and tranquilizerss. 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 glaucoma or seizures, or lung, heart, or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking oxazepam, call your doctor immediately.
- talk to your doctor about the risks and benefits of taking oxazepam if you are 65 years of age or older. Older adults should take lower doses of oxazepam because higher doses may not be more effective and are more likely to cause serious side effects.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking oxazepam.
- you should know that this medication may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
- talk to your doctor about the safe use of alcohol during your treatment with oxazepam. Alcohol can make the side effects of oxazepam worse.
- tell your doctor if you use tobacco products. Cigarette smoking may decrease the effectiveness of this medication.
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?
Take the missed dose as soon as you remember it. However if it is almost time for your 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.
What side effects can this medication cause?
Oxazepam may cause side effects. Call your doctor if any of the symptoms are severe or do not go away:
- dry mouth
- upset stomach
- changes in appetite
- restlessness or excitement
- difficulty urinating
- frequent urination
- blurred vision
- changes in sex drive or ability
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
- shuffling walk
- persistent, fine tremor or inability to sit still
- difficulty breathing or swallowing
- severe skin rash
- yellowing of the skin or eyes
- irregular heartbeat
Oxazepam may cause other side effects. Call your doctor if you experience any unusual problems during your treatment with oxazepam.
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). Throw away any medication that is outdated or no longer needed. 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.
What other information should I know?
Keep all appointments with your doctor.
Do not let anyone else take your medication. Oxazepam is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.
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.