FDA Announces New OTC Option, AARC Raises Concerns

 Updated: November 9, 2018

  Tags: Medication

image of OTC pharmacy

On Thursday, Nov. 8, the Food and Drug Administration (FDA) announced approval of Primatene Mist for over-the-counter (OTC) use to provide temporary relief for symptoms of mild, intermittent asthma for patients age 12 years and older who have been diagnosed with asthma by a health care provider.

The American Association for Respiratory Care came out in strong opposition when the FDA first announced their initiative (a few years ago) to look at prescription drugs that could safely and effectively be used OTC. We are extremely concerned about this latest action that designates Primatene Mist for OTC and the impact it could have on patients with asthma.

Patient education is key

It is essential that respiratory therapists advise their patients on the dangers of using this drug OTC without first consulting their physician. While the labeled indication is for mild or intermittent asthma, there is fear that patients, regardless of their diagnosis, will turn to it because of its accessibility. The FDA has an important “Manage Your Asthma” message that addresses this and more. It may prove helpful for your patients.

Patients who opt to self-treat their asthma or asthma symptoms will be doing so without the clinical guidance of the physician and respiratory therapist.