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Asthma treatment Primatene Mist to leave market at year's end

If you are among the 2 million Americans depending on a drugstore inhaler to deal with asthma, it may be time to schedule a doctor's appointment. At the end of the year, your only nonprescription treatment option is coming off the shelves.

The issue isn't the medication, sold as Primatene Mist. For years, it has offered safe treatment for mild asthma symptoms such as wheezing and shortness of breath. But the inhaler contains ozone-destroying chlorofluorocarbons, or CFCs, which long have been scheduled for phasing out.

After Dec. 31, you won't be able to buy Primatene Mist, the only over-the-counter inhalers approved by the U.S. Food and Drug Administration to treat asthma. Your alternatives are prescription drugs that are more expensive — and require the time and cost of a doctor's visit.

Primatene's manufacturer says it's working on a CFC-free substitute, but no one expects it to reach the market before the end-of-year deadline.

"Is this going to affect certain patients? Absolutely," said Dr. Richard Lockey, director of the division of allergy and immunology at the University of South Florida College of Medicine. "When you take (Primatene Mist) off the market — and there's nothing to replace it — you have an added cost for patients."

Already, the FDA is warning that store supplies may run low before December. (If you choose to stock up, pay attention to expiration dates.)

Now this health issue has taken on a political turn. After health officials urged consumers last week to talk to their doctors about a prescription for another medication, conservative bloggers started weighing in.

"It seems that the Obama administration would rather make people with asthma cough up money than let them make a surely inconsequential contribution to depleting the ozone layer," the Weekly Standard wrote.

In reality, the phaseout just happens to fall on President Barack Obama's watch. The FDA finalized the deadline in 2008, when Republican George W. Bush was president. The international treaty sealing the fate of CFCs dates back to 1987.

Even earlier, the United States was a leader in limiting CFCs as a propellant in consumer products packaged in aerosol cans such as pesticides and hairspray, but their use has been permitted far longer in medications. Now consumers have little recourse but to pay more for alternatives.

Primatene retails for around $20. Prescription alternatives cost $35 to $50, authorities say. Known as albuterol inhalers (Primatene contains a different drug, epinephrine), they mainly are sold under the names ProAir, Ventolin and Proventil.

If you can't afford a prescription drug, the FDA suggests asking your physician and prescription drug makers about financial assistance options. Or you can visit free clinics, public hospitals and government health programs for the poor and elderly.

FDA officials said they originally proposed removing Primatene Mist by last year, but postponed the deadline because the manufacturer thought an alternative would be available by December. While a couple of prescription inhalers using CFCs are still on the market, they also will be phased out within the next two years.

No one can say when another over-the-counter asthma drug may arrive.

"We are working on an alternative product," said Dan Dischner, spokesman for Amphastar Pharmaceuticals, the parent company of Primatene's maker, which for now has urged consumers to stock up.

To get a prescription for a replacement asthma medication, you don't have to see a specialist. USF's Lockey said primary care or family physicians should be able to help patients with mild asthma.

"The FDA probably thought that by now, the year 2011, we would have an albuterol inhaler over-the-counter," Lockey said. "This is one of those things where you come up with a plan and the plan doesn't work exactly as anticipated — and you end up with nothing as a substitute for this drug, which when used as directed was a safe drug for patients who have asthma."

Times researcher Caryn Baird contributed to this report. Letitia Stein can be reached at lstein@sptimes.com or (813) 226-3322. For more health news, visit www.tampabay.com/health.

What is asthma?

Asthma is a chronic lung disease that inflames and narrows the airways. Symptoms include wheezing (a whistling sound when you breathe), chest tightness, shortness of breath and coughing, often at night or in the early morning.

Is there a cure?

Asthma can't be cured, though it can be managed with medication and lifestyle adjustments. Symptoms, which sometimes are mild and can go away on their own, can flare up at any time. Severe asthma attacks may require emergency care and can be fatal.

How many Americans are treating their asthma with Primatene Mist?

About 2 million people use the over-the-counter inhaler, the FDA estimates. But these figures aren't exact and are several years old. Many of these people likely use it along with other asthma medications.

Sources: National Heart Lung and Blood Institute; FDA.

Asthma treatment Primatene Mist to leave market at year's end 09/26/11 [Last modified: Wednesday, September 28, 2011 4:58pm]

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