FDA Concerned About OTC Asthma Treatment
Asthmanefrin is an over-the-counter product indicated for the temporary relief of mild symptoms due to bronchial asthma.
Since its launch in September 2012, users of the product have reported several adverse effects, including increased blood pressure, increased heart rate, and coughing up pink/red colored sputum.
In addition to these reports, a nationwide recall of the product was issued earlier this year because certain lots of the Asthmanefrin Starter Kits were found to have faulty EZ Breathe Atomizers.
These devices, which turn the inhalation solution into a continuous vapor, posed a choking hazard due to the possibility of a washer being dislodged during use.
Asthmanefrin has not been evaluated by the FDA for safety and efficacy under the new drug application process. Because of these recent concerns, the FDA will be holding a meeting in early 2014 to discuss the appropriate regulatory pathways for inhaled bronchodilator drug products.
Healthcare professionals are asked to continue to report any adverse events with Asthmanefrin to the FDA.
For more information visit FDA.gov.