Washington – Certain types 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 ban Primatene Mist and similar nonprescription inhalers, said Fran Sullivan, a spokesman for Primatene manufacturer Wyeth Consumer Healthcare. The agency usually follows the advice of its outside panels of experts, though a decision can take months.
Wyeth estimates that 3 million Americans use Primatene Mist for mild or intermittent cases of asthma, 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 temporarily relieve wheezing, shortness of breath and troubled breathing, according to the FDA.
The over-the-counter inhalers that the proposed ban affects 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 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.
