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Inhalers must be green by Dec. 31




Asthma inhalers new (left) and old (right) use the drug albuterol, but the newer one has a softer spray. The new model also costs more. (Photos by Teva Pharmaceuticals)

Asthma inhalers new (left) and old (right) use the drug albuterol, but the newer one has a softer spray. The new model also costs more. (Photos by Teva Pharmaceuticals)

WASHINGTON

Asthma inhalers go “green” in the United States on Dec. 31, which will force patients still using the old-fashioned kind to make a pricey and even confusing switch.

The medicine inside these rescue inhalers — albuterol, which quickly opens airways during an asthma attack — is not changing. The chemicals used to puff the drug into the lungs are.

No more chlorofluorocarbons, or CFCs, which damage Earth’s protective ozone layer. By year’s end, all albuterol inhalers must be powered by the more eco-friendly chemical HFA, or hydrofluoroalkane.

The down side: The new inhalers cost more, $30 to $60 compared to as little as $5 or $10 for the disappearing generic CFC inhalers.

Most other developed countries already have made or will make the switch under an international agreement.

Patients face a learning curve with the new device. HFA inhalers must be used differently than the old-fashioned kind. The medicine feels and tastes different, sometimes alarming new users despite doctors’ assurances that it works just as well.

 

 

“There’s still significant confusion,” says Dr. Harvey Leo of the University of Michigan’s C.S. Mott Children’s Hospital. “Patients will tell you, ‘I don’t feel the puff anymore.'”

Calls from parents unsure how to use the new inhalers, or even what they are, have increased in the past two months as more drugstores run out of CFC-powered inhalers and automatically switch people who had been expecting a mere refill, he adds.

The change should not be a surprise. The Food and Drug Administration long has warned it was coming, and lung specialists have spent the past year easing into it many of the nation’s 20 million asthma patients, as well as millions of emphysema sufferers who also use albuterol to ease breathing.

But industry figures show that in mid-November, 20 percent of all albuterol prescriptions still were being filled with CFC versions.

Some patients may purposefully be buying up cheaper CFC inhalers before the sales ban. But many patients do not see lung specialists, or their prescription may not expire until next year and so they have not been seen recently enough to be told.

Reaching the last fraction “is, as you can imagine, a very difficult task,” says Dr. Bidrul Chowdhury, FDA’s pulmonary drugs chief. “How to get to somebody who is not tuned in?”

The CFC-free options: GlaxoSmithKline’s Ventolin HFA, Schering Plough’s Proventil HFA and Teva Specialty Pharmaceuticals’ ProAir HFA all contain albuterol. Also, Sepracor’s Xopenex HFA contains the similar medication levalbuterol.

Albuterol inhalers are for emergencies, for quick relief of wheezing. Patients also need daily medication to control their asthma and prevent flare-ups. Someone who’s using the albuterol inhaler more than a few times a month is not well-controlled, and his or her doctor needs to determine why, stresses Dr. Paul Greenberger of Northwestern University, president-elect of the American Academy of Allergy, Asthma & Immunology.

Here is the rub: Recent research suggests only one in five children has his asthma under good control; no one knows how many adults do.

The last to go CFC-free will be the poor and uninsured whose asthma is less likely to be controlled, says Leo, who researches that issue at Michigan’s Center for Managing Chronic Disease.

Albuterol manufacturers are providing free samples and posting coupons on their Web sites.

Still, specialists worry that some patients will try to save money with a decades-old nonprescription inhaler that contains a different drug, epinephrine, best known by the brand name Primatene Mist. Those inhalers also contain ozone-harming CFCs. National asthma guidelines argue against such selftreatment as too risky and less effective than albuterol. The government will allow sale of those over-the-counter inhalers until December 2011 as manufacturers reformulate.

Leo has another worry: Only one of the new inhalers counts doses used. He is monitoring emergency-room statistics to see if cost-conscious patients trying to squeeze out last drops wind up using empty inhalers.

What do patients need to know as they switch?

— Expect a softer puff instead of the CFC version’s cold blast of air in the back of the throat.

“They are getting their medicine,” says Dr. David Rosenstreich of New York’s Montefiore Medical Center. “They have to get used to it and be aware that it’s working.”

— The new inhalers clog more often because HFA makes the drug stickier. Clean the hole weekly, following the instructions unique to each brand.

— Never get the whole device wet.

The FDA says there is plenty of supply; it gave manufacturers several years to ramp up before the ban.

But do not wait until the last minute. When Eric Stoermer of Michigan made the switch in August, he waited a week for a new inhaler for his 11-year-old son Ethan. Their drugstore was temporarily out of stock.

“I ended up having to hunt around on an emergency basis,” Stoermer says. “This is a bad thing to run out of.”

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