American College of Allergy, Asthma & Immunology Issues Warning after FDA Approves Primatene Mist for Over-The-Counter Use
The Food and Drug Administration (FDA) announced yesterday that it has approved Primatene Mist for over-the-counter (OTC) use for those with mild intermittent asthma. The president of the American College of Allergy, Asthma & Immunology, Bradley Chipps, MD, stated than “anyone who has asthma should be working with an allergist to make sure they are on the appropriate medication to control their disease. People should understand they shouldn’t go off their regular prescription medication to start taking Primatene Mist instead. That could prove very dangerous.”
According to the FDA statement, Primatene Mist is approved by the FDA to provide temporary relief for symptoms of mild, intermittent asthma. This OTC drug is approved only for those who have been diagnosed with asthma by a health care provider. Asthma is a serious health condition that requires careful assessment and ongoing follow-up with a health care professional. It’s important for us to note that Primatene Mist is not a replacement for prescription asthma treatments. Patients with asthma should be under the care of a health care professional.
The FDA statement further stated that making sure that patients can understand and apply the instructions for using Primatene Mist was a critical consideration for the FDA. The new product is only appropriate for those with a diagnosis of mild, intermittent asthma. Patients with more severe asthma should not rely on it. Instead, they should be working with their health care provider to ensure an appropriate treatment plan for their condition. The product is appropriate for mild symptoms of intermittent asthma, however, even patients with mild asthma can have severe exacerbations—so it’s still important to consult a health care provider about appropriate care and have their condition reassessed. And, of course, all patients who experience severe exacerbations should go to the emergency room right away.
Finally, the FDA stated, “We recognize that some consumers will be interested in the new OTC product. Asthma symptoms and recommended treatment regimens can vary from person to person. In addition, symptoms can change over time, requiring changes in treatment. To that end, it’s important that consumers discuss asthma diagnoses and treatments with their health care providers before using any new asthma product, including an OTC product, and they should not stop the treatment currently being used without talking to them first. This is especially important because some prescription asthma medications are used to control the inflammation that causes asthma symptoms to develop and these medications must be used on a regular basis to be effective.”