[Posted 02/18/2010] FDA notified healthcare professionals and consumers that, due to safety concerns, FDA is requiring a risk management strategy (REMS) and class-labeling changes for all Long-Acting Beta-Agonists (LABAs). The REMS will require a revised Medication Guide written specifically for patients, and a plan to educate healthcare professionals about the appropriate use of LABAs. These changes are based on FDA's analyses of studies showing an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations in pediatric and adult patients as well as death in some patients using LABAs for the treatment of asthma.
Healthcare professionals are reminded that to ensure the safe use of these products:
Single-ingredient LABAs should only be used in combination with an asthma controller medication; they should not be used alone.
LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications.
LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller medication.
Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure compliance with both medications.
FDA has determined that the benefits of LABAs in improving asthma symptoms outweigh the potential risks when used appropriately with an asthma controller medication in patients who need the addition of LABAs. FDA believes the safety measures recommended will improve the safe use of these drugs. For more information visit the FDA website at: [Web] and [Web].
REMS:
FDA approved a REMS for budesonide to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of budesonide and consists of the following: communication plan. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
BUDESONIDE (bue DES oh nide) is a corticosteroid. It helps decrease inflammation in your lungs. This medicine is used to treat the symptoms of asthma. Never use this medicine for an acute asthma attack.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
This medicine is used in a nebulizer. Nebulizers make a liquid into an aerosol that you breathe in through your mouth or your mouth and nose into your lungs. You will be taught how to use your nebulizer. Follow the directions on your prescription label. Do not mix this medicine with other medicines in your nebulizer. Do not use more often than directed.
If you are also using a bronchodilator inhaler, like albuterol, use that inhaler first. Wait 5 minutes or more before using this medicine.
A patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, use it as soon as you remember. If it is almost time for your next dose, use only that dose and continue with your regular schedule, spacing doses evenly. Do not use double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular checks on your progress. Check with your health care professional if your symptoms do not improve. If your symptoms get worse or if you need your short acting inhalers more often, call your doctor right away.
The medicine may increase your risk of getting an infection. Stay away from people who are sick. Tell your doctor or health care professional if you are around anyone with measles or chickenpox.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at a room temperature between 20 and 25 degrees C (68 and 77 degrees F). Do not refrigerate or freeze. Keep unopened vials in the foil pouch. When the package has been opened, the shelf life of the unused medicine is 2 weeks when protected from light. Unused medicine should be returned to the aluminum foil envelope right away to protect them from light. Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
