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.
Clobazam 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: antidepressants; medications for anxiety, mental illness, and seizures; sedatives; sleeping pills; opioids such as codeine, fentanyl (Duragesic, Subsys), morphine (Astramorph, Kadian), or oxycodone (in Percocet, in Roxicet, others); or tranquilizers. Your doctor may need to change the dosages of your medications and will monitor you carefully. If you take clobazam 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 clobazam 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?
Clobazam is used with other medication(s) to control seizures in adults and children 2 years of age and older who have Lennox-Gastaut syndrome (a disorder that causes seizures and often causes developmental delays). Clobazam is in a class of medications called benzodiazepines. It works by decreasing abnormal electrical activity in the brain.
How should this medicine be used?
Clobazam comes as a tablet and a suspension (liquid) to take by mouth, and as an film to apply on the tongue. It is usually taken once or twice a day, with or without food. Take clobazam at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.
If you are unable to swallow the tablets whole, you may break them in half on the score mark or crush and mix them with a small amount of applesauce.
The liquid comes an adapter and two oral dosing syringes. Use only one of the two oral dosing syringes to measure your dose and save the second syringe. If the first oral syringe is damaged or lost, the second provided syringe may be used as a replacement.
To take the liquid, follow these steps:
- Before the first use, uncap the bottle and firmly insert the adapter into the neck of the bottle until the adapter top is even with the bottle top. Do not remove the adapter during the period of time you are using this bottle.
- Shake the liquid well before each use to mix the medication evenly.
- To measure your dose, push the plunger of the syringe all the way down and insert the syringe into the adapter of the upright bottle. Then turn the bottle upside down and slowly pull the plunger back until the black ring is in line with your prescribed dose.
- Remove the syringe from the bottle adapter and slowly squirt the liquid from the syringe into the corner of your mouth.
- Place the bottle cap over the adapter after each use.
- Wash the oral syringe after each use. To wash the syringe, remove the plunger completely, wash the barrel and plunger with soap and water, rinse, and allow to dry. Do not place the syringe parts in the dishwasher.
To take the film, follow these steps:
- Open the foil pouch and remove the film. Be sure that your hands are dry and clean.
- Place the film on the top of your tongue.
- Close your mouth and swallow your saliva normally. Do not chew, spit, or talk while the film dissolves. Do not take with liquids.
- Wash your hands.
If your doctor has told you to take more than one film per dose, wait until the first film has completely dissolved before applying the second film.
Your doctor will probably start you on a low dose of clobazam and gradually increase your dose, not more than once every week.
Some people may respond differently to clobazam based on their heredity or genetic makeup. Your doctor may order a blood test to help find the dose of clobazam that is best for you.
Clobazam can be habit forming. Take clobazam exactly as directed. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor.
Clobazam may help control your condition but will not cure it. Continue to take clobazam even if you feel well. Do not stop taking clobazam without talking to your doctor. If you suddenly stop taking clobazam, you may experience withdrawal symptoms such as new or worsening seizures, hallucinating (seeing things or hearing voices that do not exist), behavior changes, depressed mood, loss of contact with reality, restlessness, irritability, panic attacks, difficulty concentrating, anxiety, difficulty falling asleep or staying asleep, headache, blurred vision, eye sensitivity to light, uncontrollable shaking of a part of your body, fast heartbeat, sweating, muscle pain and stiffness, stomach or muscle cramps, nausea, diarrhea, or weight loss. Your doctor will probably decrease your dose gradually.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with clobazam and each time you refill 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.
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 clobazam,
- tell your doctor and pharmacist if you are allergic to clobazam, any other medications, or any of the ingredients in clobazam tablets, suspension, or film. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- 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 the medications listed in the IMPORTANT WARNING section and any of the following: antihistamines; dextromethorphan (Delsym, in Nuedexta, in Robitussin DM); fluconazole (Diflucan); fluvoxamine (Luvox); omeprazole (Prilosec, in Zegerid); or ticlopidine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with clobazam, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
- tell your doctor if you drink or have ever drunk large amounts of alcohol or use or have ever used street drugs or excessive amounts of prescription medications. Also tell your doctor if you have or have ever had depression, mood problems, or thoughts about harming or killing yourself, or planning or trying to do so; or lung, kidney, or liver disease.
- tell your doctor if you are pregnant or plan to become pregnant. If you take clobazam regularly during the last few months of your pregnancy, your baby may experience 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, or diarrhea. If you become pregnant while taking clobazam, call your doctor.
- if you are using hormonal contraceptives (birth control pills, patches, rings, implants, injections, or intrauterine devices), you should know that this type of birth control may not work well when used with clobazam. Hormonal contraceptives should not be used as your only method of birth control while you are taking clobazam and for 28 days after your final dose. Talk to your doctor about nonhormonal birth control methods that will work for you.
- tell your doctor if you are breastfeeding. If you are breastfeeding while taking clobazam, tell your doctor if your baby is not feeding well or is extremely drowsy.
- talk to your doctor about the risks and benefits of taking this medication if you are 65 years of age or older. Older adults should receive low doses of clobazam because higher doses may not work better and may cause serious side effects.
- you should know that clobazam may make you drowsy and affect your thinking, ability to make decisions, and coordination. Do not drive a car, operate machinery, or do other dangerous activities 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 clobazam. A small number of adults and children 5 years of age and older (about 1 in 500 people) who took anticonvulsants, such as clobazam, 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. 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); thinking about harming or killing yourself, or planning or trying to do so; 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 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 the 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?
Clobazam may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- problems with coordination
- difficulty speaking or swallowing
- change in appetite
- joint pain
Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:
- difficult, painful, or frequent urination
- cough, difficulty breathing, fever
- sores in your mouth, rash, hives, peeling or blistering skin
Clobazam 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. Do not open the foil pouch for the film until right before you are ready to use it. Store clobazam in a safe place so that no one else can take it accidentally or on purpose. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Store clobazam suspension (liquid) in an upright position. Do not use any remaining liquid more than 90 days after first opening the bottle.
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 the following:
- lack of energy
- problems with coordination
- slow, shallow breathing
- decreased urge to breathe
- blurred vision
What other information should I know?
Keep all appointments with your doctor.
Do not let anyone else take your medication. Clobazam 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.