Some asthmatics may lose their inhalers
But experts say ban on Primatine Mist, other OTC inhalers could move patients to better drugs.
NEW YORK (CNNMoney.com) - Asthmatics take note: the days of Primatine Mist could be numbered.
On Jan. 24, an advisory committee for the Food and Drug Administration will vote on whether asthmatics really need over-the-counter, ozone-depleting inhalers such as Wyeth's (up $0.64 to $48.28, Research) Primatine Mist, which uses a compound called epinephrine. Asthmatics use the inhalers to help breathe when they have severe reactions to allergies.
A negative vote from the committee could lead to an FDA ban on all OTC, epinephrine-based inhalers, which use chlorofluorocarbons, or CFCs, as a propellant. The use of CFCs, which have been blamed for eroding the ozone layer, has been sharply curtailed since the 1970s.
But there are no epinephrine-based inhalers on the market that use hydrofluroalkane, or HFA, the environmentally friendly option of delivery.
Primatine Mist is the biggest player in this particular market, according to Wyeth, but sales for the inhaler are slim compared to the company's total revenue. The product totaled $43 million in sales for Wyeth in 2005, a mere sliver of overall company sales, which totaled $14 billion in the first nine months of 2005.
"While this product [Primatine Mist] may be small in terms of revenue to the company, it is still important to Wyeth in that it provides relief to millions of asthmatics," said Wyeth spokeswoman Fran Sullivan. "It is our intent to go to the FDA advisory committee meeting on Jan. 24 and present data to show that Primatine Mist should remain available to consumers."
A chance to help asthmatics
But allergists say that epinephrine provides less of a benefit than generic albuterol, which is available as a prescription.
"Inhaled epinephrine does have some affect, but it is not anywhere near as effective as the [albuterol-based] prescription inhalers that provide the same kind of role," said Dr. Richard Ahrens, allergist, pediatric pulmonologist and professor at the University of Iowa.
In fact, Ahrens and other allergists are worried that over-the-counter availability of epinephrine might be keeping asthmatics from seeking professional help in treating their extreme reactions to allergies, and that a ban might prompt them to seek real help.
"[Epinephrine] may provide some benefit to patients, but when they start to have trouble, it really isn't effective and it may keep them from getting other care," said Ahrens, adding that epinephrine is a stimulant, resulting in rapid heart beat, sweating and "jitteriness."
Dr. Jay Portnoy, Chief of Allergy at Children's Mercy Hospital in Kansas City, Mo., said that asthmatics would benefit by allowing albuterol-based inhalers to be sold OTC, with an education program urging them to seek professional help for their allergy reactions.
"I think I would like to see albuterol over the counter with a strong advertising campaign attached to it," said Portnoy, although he also would like to have it sold with controls, the way cold medications with pseudoephedrine are now sold.
To read about an upcoming FDA vote on a diet drug, click here.