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New OTC Primatene Mist Approved By FDA

Lisa Feierstein Allergies, Asthma, Breathe EZ Leave a comment   , , , ,

Should you consider using it as part of your Asthma Treatment Plan?

Primatene Mist ® was removed from the market back in 2011 due to the propellant used in the inhaler medication. Late last year the FDA approved a new over-the-counter version of the drug, which is now widely available. This new version uses the same active ingredient but does not contain CFCs (chlorofluorocarbons) which are known to deplete ozone in our atmosphere.

Asthma Experts Urge Caution

A number of asthma organizations have voiced strong concerns over the new Primatene Mist inhaler since it creates the impression that the management and treatment of asthma is a do-it-yourself proposition. Asthma is a chronic condition that requires ongoing management with your healthcare provider – whether it is mild, moderate or severe.

As a chilling reminder: 10 people die every day from asthma related complications

The active ingredient in Primatene mist is racemic epinephrine. This medication is not a recommended asthma treatment and can also give a false sense of control by masking asthma symptoms.

Lack of control and the often associated over use of quick-relief medications leads to respiratory complications and sometimes death in people with asthma. Experts worry that this new over-the-counter medication option will only escalate that scenario. Out of control symptoms followed by over use of a medication that masks symptoms can in turn lead to life-threatening complications.

FDA Approval and Recommendations

Asthma Rescue InhalerFDA officials approved the new medication in hopes of providing another cost effective treatment option, especially to patients with mild asthma. The active ingredient in the medication is the same, just a new propellant to allow it to be administered via a metered dose inhaler and with new administration instructions.

The FDA has only approved the medication in patients over 12 years of age. They caution that the medication should only be used by those already diagnosed with asthma, and not to treat symptoms such as wheezing, chest tightness or shortness of breath that may be related to other conditions.

The Manufacturer Weighs In

Amphastar, the manufacturer of Primatene Mist, indicates the over-the-counter medication is to be used for “temporary relief of mild symptoms of intermittent asthma” on their product website.

A Plan for Asthma Control

Remember to always check with your healthcare provider before making a change to your or your child’s asthma treatment regime and asthma action plan. Check out these additional resources for more information about this new medication, tools to navigate treatment options and a refresher on understanding asthma control.

Additional Resources

FDA – Safely Using the Newly Available OTC Asthma Inhaler Primatene Mist

Shared Decision Making Tool developed by the American College of Allergy, Asthma, and Immunology (ACAAI), American College of Chest Physicians (CHEST), and the Allergy and Asthma Network

Asthma Statistics and Understanding Asthma control


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