Black Box Warning Removed from Certain Asthma Medications
December 21, 2017 – The U.S. FDA has announced the removal of a black box warning cautioning against asthma-related death from certain medications. Drugs that contain both an inhaled corticosteroid (ICS) and a long-acting beta agonist (LABA) have been found in recent studies to not significantly increase the risk of asthma-related death or hospitalizations when compared to the use of ICS drugs alone.
A black box warning, or Boxed Warning, is the strongest warning the FDA can place on an approved drug. It is used to draw attention to serious and life-threatening risks associated with use of the drug. In 2011, the FDA requested that three drug manufacturers—Merck, GlaxoSmithKline, and AstraZeneca—conduct clinical trials to further evaluate the safety of FDA-approved LABA/ICS combination products. Four clinical trials involving 41,297 patients assessed both the efficacy of ICS/LABA combination treatments, and the risk of serious asthma-related events. In addition to showing no significantly higher risk of asthma-related hospitalization or death compared to treatment with ICS alone, ICS/LABA combinations were found to reduce the exacerbation of asthma versus using an ICS only. Exacerbation in this instance was defined as the deterioration of asthma leading to the use of systemic corticosteroids for a minimum of three days, or an emergency room visit or in-patient hospitalization due to asthma requiring treatment with systemic corticosteroids.
The FDA has advised healthcare professionals to review the most current approved drug labels for ICS/LABA combinations for updated recommendations. Patients who have questions about their asthma medications should consult with their physicians before changing or stopping their prescribed treatments. Examples of ICS/LABA products currently on the U.S. market include GlaxoSmithKline’s Advair® (fluticasone propionate and salmeterol), AstraZeneca’s Symbicort® (budesonide and formoterol fumarate dehydrate), and Merck’s Dulera® (mometasone furoate and formoterol fumarate dihydrate).
Products that contain LABA drugs only will still carry the black box warning.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.