TOPIC: Benzodiazepine Drug Class: Drug Safety Communication - Boxed Warning Updated to Improve Safe Use
AUDIENCE: Patient, Health Professional, Pharmacy
ISSUE: The FDA is requiring the Boxed Warning, FDA's most prominent warning, be updated by adding other information to the prescribing information for all benzodiazepine medicines. This information will describe the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions consistently across all the medicines in the class. The FDA is also requiring updates to the existing patient Medication Guides to help educate patients and caregivers about these risks.
Other changes are also being required to several sections of the prescribing information, including to the Warnings and Precautions, Drug Abuse and Dependence, and Patient Counseling Information sections.
BACKGROUND: Benzodiazepines are a class of medicines approved to treat generalized anxiety disorder, insomnia, seizures, social phobia, and panic disorder.
Health Care Professionals
- Consider the patient's condition and the other medicines being taken, and assess the risk of abuse, misuse, and addiction, available at: http://bit.ly/3lfHUIG.
- Limit the dosage and duration of each medicine to the minimum needed to achieve the desired clinical effect when prescribing benzodiazepines, alone or in combination with other medicines.
- Use a gradual taper to reduce the dosage or to discontinue benzodiazepines to reduce the risk of acute withdrawal reactions.
- Take precautions when benzodiazepines are used in combination with opioid addiction medications, available at: http://bit.ly/3eNL9ET.
Patients, Parents, and Caregivers
- Always tell your health care professionals about all the prescription and over-the-counter (OTC) medicines you are taking or any other substances you are using, including alcohol.
- Take benzodiazepines and all medicines exactly as prescribed by your health care professional
- Discuss a plan for slowly decreasing the dose and frequency of your benzodiazepine(s) with your health care professional.
- Contact your health care professional if you experience withdrawal symptoms or your medical condition worsens.
- Go to an emergency room or call 911 if you have trouble breathing or other serious side effects such as seizures.
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Oxazepam may increase the risk of serious or life-threatening breathing problems, sedation, or coma if used along with certain medications. Tell your doctor if you are taking or plan to take certain opiate medications for cough such as codeine (in Triacin-C, in Tuzistra XR) or hydrocodone (in Anexsia, in Norco, in Zyfrel) or for pain such as codeine (in Fiorinal), fentanyl (Actiq, Duragesic, Subsys, others), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Astramorph, Duramorph PF, Kadian), oxycodone (in Oxycet, in Percocet, in Roxicet, others), and tramadol (Conzip, Ultram, in Ultracet). Your doctor may need to change the dosages of your medications and will monitor you carefully. If you take oxazepam with any of these medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care immediately: 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 or using street drugs during your treatment with oxazepam also increases the risk that you will experience these serious, life-threatening side effects. Do not drink alcohol or use street drugs during your treatment.
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 (in Ritary, in Sinemet, in Stalevo); medication for depression, seizures, Parkinson's disease, asthma, colds, or allergies; muscle relaxants; oral contraceptives; phenytoin (Dilantin, Phenytek); probenecid (Probalan, in Col-Probenecid); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); sedatives; sleeping pills; theophylline (Elixophyllin, Theo 24, Theochron); or tranquilizers. 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 breastfeeding. 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.
- 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).
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
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.
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.
¶ This branded product is no longer on the market. Generic alternatives may be available.