I completely understand why many asthma patients would be concerned when we recommend a medication that carries a risk of asthma related death. It seems counterintuitive to prescribe a medication for asthma that actually carries a warning that the medication could increase your risk of dying from asthma. Certain asthma medications have had a specific black box warning regarding long acting bronchodilators (LABA) due to findings from the Salmeterol multicenter research asthma trial (SMART trial). LABA medications used alone for asthma were found to increase the risk of asthma death. The risk of death was small but statistically significant in individuals being treated with salmeterol which is a type of LABA. This label was challenging because asthmatics may require inhaled steroid (ICS) – LABA combination medications to adequately control their asthma.
When the FDA placed the black box warning on LABA medication they included the warning on ALL asthma medications that contained any LABA at all. Unfortunately, this included the LABA-ICS combination medications like Symbicort, Advair, Dulera, Airduo, and Breo. For years we knew the ICS-LABA combination medications were safe and the concern was primarily for LABA used alone but as prescribing physicians we’d have a lengthy discussion with concerned patients. We knew the studies were being done but still had that “label” to contend with.
Most Asthma specialists (allergists and pulmonologists) knew that using LABA’s in combination with an ICS was very safe. The studies were done and the data was finally presented to the FDA and ultimately the Black Box warning was removed earlier this month. The FDA rarely removes a black box warning for a medication.