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.
Diazepam 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 diazepam 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 diazepam 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?
Diazepam is used to relieve anxiety and to control agitation caused by alcohol withdrawal. It is also used along with other medications to control muscle spasms and spasticity caused by certain neurological disorders such as cerebral palsy (condition that causes difficulty with movement and balance), paraplegia (inability to move parts of the body), athetosis (abnormal muscle contractions), and stiff-man syndrome (a rare disorder with muscle rigidity and stiffness). Diazepam is also used along with other medications to control seizures. Diazepam is in a class of medications called benzodiazepines. It works by calming abnormal overactivity in the brain.
How should this medicine be used?
Diazepam comes as a tablet, a solution, and as a concentrate (liquid) to take by mouth. It is usually taken 1 to 4 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 diazepam exactly as directed.
Diazepam concentrate comes with a specially marked dropper for measuring the dose. Ask your pharmacist to show you how to use the dropper. Dilute the concentrate in water, juice, or carbonated beverages just before taking it. It also may be mixed with applesauce or pudding just before taking the dose. Stir the mixture gently for a few seconds. Take the entire mixture immediately; do not store it for future use.
Diazepam can be habit-forming. Do not take a larger dose, take it more often, or for a longer time than your doctor tells you to.
Tolerance may develop with long-term or excessive use, making the drug less effective. This medication must be taken regularly to be effective. 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 diazepam, you may experience anxiousness, sleeplessness, and irritability. Your doctor probably will decrease your dose gradually.
If you are taking diazepam along with other medications to control seizures, do not stop taking diazepam without talking to your doctor, even if you experience side effects such as unusual changes in behavior or mood. If you suddenly stop taking diazepam, your seizures may get worse. Your doctor will probably decrease your dose gradually.
Other uses for this medicine
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking diazepam,
- tell your doctor and pharmacist if you are allergic to diazepam, alprazolam (Xanax), chlordiazepoxide (Librium, in Librax), clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), estazolam, flurazepam, lorazepam (Ativan), oxazepam, temazepam (Restoril), triazolam (Halcion), any other medications, or any of the ingredients in diazepam products. Ask your pharmacist for a list of the ingredients.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements, you are taking. Be sure to mention any of the following: antihistamines; barbiturates such as phenobarbital (Luminal); cimetidine (Tagamet); digoxin (Lanoxin); disulfiram (Antabuse); fluoxetine (Prozac); fluvoxamine (Luvox); isoniazid (Laniazid, in Rifamate, in Rifater); ketoconazole; medications for anxiety, depression, mental illness, seizures, Parkinson's disease, asthma, colds, or allergies; metoprolol (Lopressor, Toprol XL); monoamine oxidase (MAO) inhibitors including isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate); muscle relaxants; phenothiazine medications for mental illness or nausea such as chlorpromazine, fluphenazine, prochlorperazine (Compro, Procomp), and promethazine (Promethegan); omeprazole (Prilosec); probenecid (Probalan, in Col-Probenecid); propranolol (Hemangeol, Inderal, Innopran); ranitidine (Zantac); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); sedatives; sleeping pills; theophylline (Elixophyllin, Theo 24, Theochron); tranquilizers; or valproic acid (Depakene). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have myasthenia gravis (a disorder of the nervous system that causes muscle weakness), sleep apnea (condition in which a person briefly stops breathing many times during the night), or lung or liver disease. Also, tell your doctor if you have narrow angle glaucoma (a serious eye condition that may cause loss of vision. Your doctor will probably tell you not to take diazepam. Diazepam should not be used in infants younger than 6 months of age.
- tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs, or have overused prescription medications. Also, tell your doctor if you have or have ever had open-angle glaucoma (increase in internal eye pressure that damages the optic nerve); depression or other mental illness; seizures; or heart disease.
- tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking diazepam, call your doctor immediately.
- tell your doctor if you are breastfeeding. Do not breastfeed while you are taking diazepam.
- talk to your doctor about the risks and benefits of taking diazepam if you are 65 years of age or older. Older adults should not usually take diazepam because it is not as safe as other medications that can be used to treat the same conditions.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking diazepam.
- you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
- you should know that your mental health may change in unexpected ways and you may become suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are taking diazepam for the treatment of epilepsy. A small number of adults and children 5 years of age and older (about 1 in 500 people) who took anticonvulsants such as diazepam to treat various conditions during clinical studies became suicidal during their treatment. Some of these people developed suicidal thoughts and behavior as early as one week after they started taking the medication. There is a risk that you may experience changes in your mental health if you take an anticonvulsant medication such as diazepam, but there may also be a risk that you will experience changes in your mental health if your condition is not treated. You and your doctor will decide whether the risks of taking an anticonvulsant medication are greater than the risks of not taking the medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on dangerous impulses; difficulty falling or staying asleep; aggressive, angry, or violent behavior; mania (frenzied, abnormally excited mood); talking or thinking about wanting to hurt yourself or end your life; withdrawing from friends and family; preoccupation with death and dying; giving away prized possessions; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.
What should I do if I forget a dose?
If you take several doses per day and miss a 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?
Diazepam may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- muscle weakness
- dry mouth
- difficulty urinating
- frequent urination
- changes in sex drive or ability
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:
- loss of control of bodily movements
- uncontrollable shaking of a part of the body
- slurred speech
- slowed breathing and heartbeat
Diazepam may cause other side effects. Call your doctor if you have any unusual problems while 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).
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
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.
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.
Symptoms of overdose may include:
- slowed breathing and heartbeat
- loss of consciousness
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to diazepam.
If you are taking diazepam along with other medications to control seizures and have an increase in their frequency or severity, call your doctor. Your dose of diazepam or the other medications may need to be adjusted. If you use diazepam for seizures, carry identification (Medic Alert) stating that you have epilepsy and that you are taking diazepam and other medications.
Do not let anyone else take your medication. Diazepam is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist any questions you have about refilling your prescription.
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.