FDA approves return of popular Primatene Mist asthma inhaler

November 8, 2018 by Linda A. Johnson
FDA approves return of popular Primatene Mist asthma inhaler
This undated product image provided by Amphastar shows Primatene Mist. A new version of the once-popular asthma inhaler Primatene Mist will soon return to U.S. stores. The Food and Drug Administration on Wednesday, Nov. 7, 2018, approved its over-the-counter aerosol inhaler for ages 12 and up. (Amphastar via AP)

A new version of the once-popular asthma inhaler Primatene Mist will soon return to U.S. stores.

The Food and Drug Administration approved the over-the-counter aerosol inhaler late Wednesday. It's for temporary relief of mild, intermittent asthma symptoms in people ages 12 and up.

The original Primatene Mist was discontinued seven years ago because the inhaler's ozone-depleting propellant had been banned. That version had been marketed for half a century, including in memorable TV ads.

The new product developed by Amphastar Pharmaceuticals uses a safer propellant. The inhaler will cost about $25 and contain 160 doses. It should be available by the end of the year.

"Rescue inhalers" are meant to quickly relieve asthma symptoms such as wheezing, coughing, shortness of breath and chest tightness, which can be triggered by pollen, mold, dust mites, pet dander, stress or exercising in the cold.

Primatene Mist's active ingredient, the hormone epinephrine, relaxes muscles in the lungs to increase airflow. The product is the only FDA-approved over-the-counter inhaler. Numerous prescription rescue inhalers, containing the medicine albuterol or levalbuterol, are available.

In a statement Thursday, FDA officials noted concerns that some people may inappropriately use or overuse the new inhaler. The agency said it should not be substituted for prescription treatments or used by people with severe asthma.

Primatene Mist was pulled from stores in 2011, but it still has many fans, including tens of thousands who have liked Facebook pages advocating its return. TV ads for the old version touted its speedy relief with endorsements from athletes such as Bob Gibson and Jackie Joyner-Kersee, or by showing a gasping person getting relief as a stopwatch ticked off 15 seconds.

An Amphastar subsidiary bought rights to the product's name and spent several years improving it.

The new version contains less alcohol and epinephrine, which can increase heart rate, especially if the inhaler is used too much. Side effects include tremors and dizziness.

Explore further: FDA phases out inhaler due to environmental impact

Related Stories

FDA phases out inhaler due to environmental impact

September 22, 2011
(AP) -- Asthma patients who rely on over-the-counter inhalers will need to switch to prescription-only alternatives as part of the federal government's latest attempt to protect the Earth's atmosphere.

FDA approves once-a-day inhaler from Glaxo

May 10, 2013
The Food and Drug Administration says it has approved a new once-a-day inhaler drug from GlaxoSmithKline for patients with chronic lung disease.

Tudorza pressair approved for COPD

July 24, 2012
(HealthDay) -- The Tudorza Pressair (aclidinium bromide) inhaler has been approved by the U.S. Food and Drug Administration to treat narrowing of the lung airways associated with chronic obstructive pulmonary disease (COPD) ...

What treatable traits predict future asthma attacks?

September 19, 2018
Investigators have assessed the prevalence of treatable traits in severe asthma and have determined which specific traits are predictive of future asthma attacks. Their findings, which are published in Respirology, are the ...

Asthmatic schoolchildren are 'uncomfortable' using their inhalers

March 29, 2017
Poor asthma control and knowledge are common in children with doctor-diagnosed asthma, according to research by Queen Mary University of London (QMUL).

Recommended for you

Scientists shine new light on link between obesity and cancer

November 12, 2018
Scientists have made a major discovery that shines a new, explanatory light on the link between obesity and cancer. Their research confirms why the body's immune surveillance systems—led by cancer-fighting Natural Killer ...

Fecal transplant effective against immunotherapy-induced colitis

November 12, 2018
For the first time, transplanting gut bacteria from healthy donors was used to successfully treat patients suffering from severe colitis caused by treatment with immune checkpoint inhibitors (ICIs). The study from The University ...

Two-pronged device enables maverick immune cells to identify and kill cancers

November 12, 2018
Immune cells called Gamma Delta T cells can act independently to identify and kill cancer cells, defying the conventional view of the immune system, reveals new research from the Francis Crick Institute and King's College ...

Suicide handshakes kill precursor T cells that pose autoimmune dangers

November 12, 2018
Ball lands in cup; cup triggers spring; spring clamps lever onto ball and holds it tight. That's a rough description of newly discovered cellular mechanisms that eliminate T cells that may cause autoimmune disorders.

Exosomes 'swarm' to protect against bacteria inhaled through the nose

November 12, 2018
Bacteria are present in just about every breath of air we take in. How the airway protects itself from infection from these bacteria has largely remained a mystery—until now. When bacteria are inhaled, exosomes, or tiny ...

Researchers find new pathway to regulate immune response, control diseases

November 9, 2018
Researchers at The University of Texas at Arlington have found a potential new pathway to regulate immune response and potentially control inflammatory diseases of the central nervous system such as meningitis and sepsis.


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.