WASHINGTON Jan 24, 2006 Millions of nonprescription inhalers used for decades by asthma sufferers, often against the advice of doctors, could be taken off drugstore shelves because they contain propellants that harm the ozone layer.
An advisory panel voted 11-7 Tuesday to recommend that the Food and Drug Administration remove the "essential use" status that Primatene Mist and other similar nonprescription inhalers require to be sold, spokeswoman Laura Alvey said. Final revocation of that status would mean a de facto ban on their sale.
The FDA usually follows the advice of its outside panels of experts, though a decision can take months. If the agency opts to follow the recommendation, it would begin a rulemaking process that would include public comment, Alvey said.
Wyeth Consumer Healthcare estimates that 3 million Americans use Primatene Mist for mild or intermittent cases of asthma, spokesman Fran Sullivan said. About two-thirds also use a prescription inhaler but rely on Primatene as a backup. Another 700,000 use the inhalers because they don't have a prescription or lack health insurance, he said.
The company is the biggest maker of epinephrine inhalers, with $43 million in sales last year. The drug opens air passages to the lungs to relieve temporarily wheezing, shortness of breath and troubled breathing, according to the FDA.
The over-the-counter inhalers proposed to be banned contain the drug epinephrine along with chlorofluorocarbons, or CFCs, which propel the medicine into the lungs of asthmatics.
CFCs were long used as aerosol propellants in a variety of products but are being phased out because they harm the Earth's protective ozone layer. In March, the FDA said inhalers using CFCs to dispense the prescription drug albuterol would be banned at the end of 2008.
On Tuesday, Wyeth asked that the FDA stay any such ban on Primatene Mist until it is ready to market an approved CFC-free version, said its representative, Dr. Sumon Wason. Wyeth hopes to have such an inhaler ready for sale in 2009 or 2010, Wason added.
"We were asking for time to continue with the reformulation process," Wason said following the vote, adding that the company would try to negotiate a delay.
Many doctors question whether over-the-counter inhalers like Primatene Mist should even be sold. Most recommend the use of prescription albuterol inhalers.
"I'd like to see it go away, personally, because I'd like to see people get proper treatment and I think people who are using Primatene are not," said Dr. Kathleen Sheerin, an allergist with the Atlanta Allergy & Asthma Clinic.
Tuesday's vote was only to consider whether Primatene Mist and similar inhalers can be considered an "essential" use of ozone-depleting chlorofluorocarbons. That's a requirement if they are to be legally distributed.
Wyeth, based in Madison, N.J., argued that its product meets the three criteria needed for it to be considered essential.
"It provides an important public health benefit, there's no other OTC alternative to CFC epinephrine inhalers, and the environmental risk from the release of CFCs from Primatene is small and justified given the benefit it provides," Sullivan said.
One of the concerns with Primatene, which has been used since the 1960s, is its effect on the heart, said Tim Op't Holt, a respiratory therapist with Victory Health Partners, a Mobile, Ala., clinic for uninsured patients.
"It's like putting a tack in the wall with a sledgehammer, because epinephrine has such a potent cardiovascular effect," Op't Holt said.
Sullivan said, "The reality is, if every patient could have access to prescription products, it would probably serve them better."