OTC asthma inhalers on the verge of extinction
FDA panelists suggest that Primatine Mist, other asthma inhalers, be stripped of OTC status.
NEW YORK (CNNMoney.com) - An FDA advisory committee voted to take away over-the-counter status for asthma inhalers that use the chemical epinephrine and an ozone-depleting propellant on Tuesday, but the vote is not a final decision.
The 11-7 vote from the Pulmonary-Allergy Drugs Advisory Committee is not considered binding, but is a suggestion from a panel of experts. The Food and Drug Administration will consider the panel's vote when he decides, at a later date, whether epinephrine inhalers should remain OTC. The FDA takes the advice of its panels most of the time.
Asthmatics use the inhalers to help themselves breathe when they have severe allergy reactions. But the epinephrine-based inhalers use cholorfluorocarbons, or CFCs, as a propellant. CFCs have been blamed for eroding the ozone layer and since the 1970s have been gradually phased out.
Primatine Mist from Wyeth (down $0.51 to $46.45, Research) is the biggest player in this particular market, but it only accounted for $43 million in 2005 sales, compared to $14 billion for total sales during the first nine months of 2005, in the most recent figures available.
Some 3 to 5 percent of adults and 7 to 10 percent of children suffer from asthma, according to the National Institutes of Health. There are no epinephrine-based inhalers on the market that use hydrofluroalkane, or HFA, the environmentally friendly option of delivery, and there are no epinephrine-based inhalers available as a prescription.
Prescription inhalers use albuterol as their active compound and HFA as a propellant. Albuterol is more effective in treating asthma, according to Dr. Richard Ahrens, allergist, pediatric pulmonologist, professor at the University of Iowa and former chair of the Pulmonary-Allergy Drugs Advisory Committee.
So if the FDA decides to get rid of OTC epinephrine-based inhalers, what does these mean for asthmatics?
"For patients who are receiving asthma care from physicians and using prescription inhalers, this means basically nothing, because they wouldn't be using this anyhow," said Ahrens. "But it does mean that people who, for whatever reasons, were treating their asthma on their own with OTC medications would no longer have this available."
If users of epinephrine-based inhalers suddenly find themselves empty-handed, Ahrens suggested they "seek appropriate medical care so they can get their asthma appropriately treated with the asthma medications that are available."