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Primatene Mist Pulled Off Market. Now What?

By Harriet Spitzer-Picker

As a Certifed Asthma Educator (AE-C), I am required to learn the history of asthma medications and the latest treatment options.  A significant new development is one that we have anticipated for a long time—the withdrawal at the end of 2011 of the over-the-counter rescue inhaler, Primatene Mist, from the market.  Primatene used an older ingredient, inhaled epinephrine, that carried the risk of more side effects and less effectiveness than the most commonly prescribed inhalers of today.  I have never known a pulmonologist, allergist, or generalist to recommend inhaled epinephrine to their patients for treating asthma.

However, this medicine was extremely popular, used by an estimated 15-20% of asthma sufferers as their primary treatment, because it was the only rescue asthma inhaler available in the United States without a prescription.  The FDA pulled Primatene off shelves not for safety reasons, but because it used a propellant called chlorofluorocarbon, or CFC, that has been shown to damage the ozone layer of the atmosphere.   Many, including Dr. Ehrlich, have questioned whether the levels released by medical aerosols were all that consequential compared to industrial CFCs or even deodorant.  Regardless, the FDA announced 10 years ago that all medical inhalers must stop using this ingredient by the end of 2011.  Primatene did not remove the CFCs, so it was removed from the market.

There are two reasons a medication is made prescription vs. OTC.  The first reason is that the medication itself can be dangerous or likely to be abused.  The other reason is that the FDA has determined that the condition the medicine is treating should be under the care of a qualified physician.

The fact that a medicine has OTC status does not always mean it is considered safer than prescription medicines.  Look at pseudoephedrine—a relative of the active ingredient Primatene—a fixture on drugstore shelves for decades; it is now being restricted because it is a precursor for crystal meth.  Other drugs may be dangerous if overused, but they have no recreational use.  Aspirin and acetaminophen, for example, can be toxic, but it would be impractical if most people went to the doctor every time they had a headache.

Asthma, however, is a serious and complex set of symptoms.  Uncontrolled it causes permanent damage.  That’s why every asthma medication introduced over that past 50 years has been available by prescription only.  The FDA wants asthma patients to use these medications only under the care and supervision of a doctor.  Primatene was introduced in the early 1950s when the criteria were different and has enjoyed OTC status ever since.

In a 2005 survey conducted by the manufacturer of Primatene, only 11% of those queried replied that they used it because it worked best for their asthma.  The most popular responses were that the medication was quick and easy to obtain, the patients did not want to see a doctor, lack of health insurance, and so on.

Furthermore, Primatene’s label stated that it was not to be used without a doctor’s diagnosis of asthma and to see a doctor if you had more than two asthma attacks in a week.  In other words, even Primatene itself said it should be used only if a doctor said so.

With extremely mild asthma and a doctor’s say-so, the occasional use of a rescue inhaler is an acceptable treatment.  In that event, I agree that Primatene may have been the best option, considering cost, ease, and availability.  Those criteria are not trivial.  But frequently it was used way too often just to help people get through their day without seeing a doctor.

The maker of Primatene had ten years to create an hydrofluoroalkane-(HFA) propelled version.  All other drug companies managed to.  HFA versions of albuterol, the rescue inhaler recommended by the vast majority of doctors, have been available since 2008.  Primatene tried to lobby the FDA at the last minute for an exemption to the CFC ban and lost.  They are reportedly working with a partner on a new HFA version that could be available on the market at any time.  The FDA will not comment on any applications, including whether one has even been received.  Primatene is being required to do the full application process with trials, so it is difficult to estimate timeframes.  Certainly, Primatene’s goal is to reintroduce a new reformulated inhaler at a very low price, while keeping the OTC status.  If it should be reintroduced as a prescription-only medicine, it would be very unsuccessful. Almost no doctor would prescribe inhaled epinephrine because of the jolt it gives to the heart as well as the lungs.

Until the time a new OTC inhaler is available, you will have to rely on prescription alternatives.  There are generic, low-cost options available.  However, in most cases, your doctor will recommend a long-acting controller medication that should reduce the need for rescue inhalers in the first place.  This will lead to a more productive life, with fewer days lost at school and work and better overall health.

A Certified Asthma Educator can assist in many ways.  We can help you find the right doctor, clinic, or nurse practitioner.  We can help you understand your symptoms.  We can also assist with the treatment plan and helping make sure you are using the proper technique for using inhalers, which are admittedly trickier than aerosols.   We can create and manage your asthma action plan and we can assist with important lifestyle changes including allergies and diet, two areas closely related to asthma.

If cost is preventing you from seeing a doctor, please be aware that the government Health and Human Services Administration funds health centers that provide health care to all Americans, whether or not they have health insurance or the money to pay for health care.  You can find an affordable health center here.

The OTC status of a drug like Primatene Mist should not be the only criterion for choosing it.  Your health is too important.

Harriet Spitzer-Picker has written asthma programs for managed care companies, as well as the Asthma Basics curriculum for the New York City Department of Health.  She graduated from Pace University where she studied Theatre and Psychology, and received her Masters in Educational Theater from New York University.  Harriet is a New York State certified teacher and taught in the New York Public Schools.   She lives in New York with her husband and two boys, all of whom are asthmatic and have food allergies.

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