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 will begin a rulemaking process that includes 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. An additional 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 temporary 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.
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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, Sumon Wason. Wyeth hopes to have such an inhaler ready for sale in 2009 or 2010, Wason added.
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“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.
Great work, FDA! Thanks!
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