Beware Over-the-Counter Primatene Mist
Beware Over-the-Counter Primatene Mist: Approved for Asthma
In November 2018, the U.S. Food and Drug Administration (FDA) approved Primatene Mist for the treatment of mild intermittent asthma in patients ages 12 and older. It is the only over-the-counter inhaler approved by the FDA for the treatment of asthma in the United States.
What is Primatene Mist?
The active ingredient is epinephrine, also known as adrenaline. It is a hormone normally produced by both the adrenal glands (over 90% found in the blood circulation) and a small number of nerve cells in the medulla (part of the midbrain). Epinephrine plays an important role in the fight-or-flight response by increasing blood flow to muscles, making the heart pump more blood, and increasing blood sugar levels.
As a medication, epinephrine is made by Amphastar Pharmaceuticals, Inc. The medication was removed from pharmacy shelves after December 31, 2011, because it contained the propellant – chlorofluorocarbon (CFC) – which was found to contribute to depletion of the ozone layer.
Brief background on the current approval of Primatene Mist
In 2012, Dr. Monica Kraft, then president of the American Thoracic Society, gave testimony at the U.S. Congress against future approval of epinephrine because it “not one of the medications that are considered safe for the treatment of asthma.”
In 2014, the pharmaceutical company developed a replacement using a different propellant – hydrofluoroalkane – and requested approval. The FDA hosted a public call for input and held an advisory committee meeting. The panel of experts determined that the safety of the inhaler device had not been established.
In 2018, Amphastar Pharmaceuticals, Inc. submitted a new request after addressing dose counter concerns. The request was approved by the U.S. FDA in 2018.
How Does Primatene Mist Work?
Epinephrine stimulates beta-receptors in the smooth muscle that wraps around breathing tubes (beta-2) to cause relaxation, but also stimulates receptors in the heart (beta-1) that can cause a rapid heart rate, an irregular heart beat, and high blood pressure. In contrast, albuterol (brand names: ProAir, Proventil, and Ventolin) is selective for stimulating beta-2-receptors in the muscle around the breathing tubes, and has very little effect on beta-1 receptors in the heart and blood vessels. Thus, albuterol is considered much safer than epinephrine.
What are the Side Effects of Primatene Mist?
Common side effects include shakiness, anxiety, and sweating. A fast heart rate and high blood pressure may occur.
What Are the Safety Concerns of Primatene Mist?
Misuse and overuse of Primatene have been well documented. Stimulation of the heart may actually worsen symptoms due to heart disease than can mimic asthma (wheezing, cough, and shortness of breath). Use as well as overuse has been associated with people dying. Also, patients may self-medicate with Primatene Mist, thereby delaying effective care.
What Are The Costs?
Over-the-counter Primatene Mist costs about $30 compared with generic albuterol which costs more. The actual cost of albuterol will depend on your health insurance coverage. A health care professional is required to prescribe albuterol.
What Does This Mean For Those With COPD?
Patients with COPD may choose to buy Primatene Mist over-the-counter rather than use albuterol as a rescue inhaler. However, neither should be used as a maintenance medication for COPD, but only used as needed.
Beware Over-the-Counter Primatene Mist
I advise against use of Primatene Mist because of safety concerns. It can cause a fast heart rate and possible heart irregularity, which are quite unlikely with albuterol use. Albuterol is a much safer alternative rescue inhaler.