FDA advisory committees turn down Primatene HFA application for OTC status

SILVER SPRING, Md. — A pair of Food and Drug Administration advisory committees on Tuesday voted against the over-the-counter sale of Armstrong Pharmaceuticals' Primatene HFA, an epinephrine inhalation aerosol indicated for the temporary relief of mild symptoms of intermittent asthma for people ages 12 years or older.

Panelists at the joint meeting of the Nonprescription Drugs Advisory Committee and the Pulmonary-Allergy Drugs Advisory Committee voted 18 against and six in favor of bringing what amounts to Primatene Mist — a one-time $100 million brand — back to store shelves. 

A small majority (14-10) advised that the Primatene HFA inhaler was efficacious, but safety was an issue. The two panels voted 17-7 against its safety for OTC use. 

The most common adverse events that occurred more frequently in more than 3% of patients were tremor, throat irritation, cough, chest discomfort and feeling jittery, according to a published report. 

“OTC … provides asthmatics access without the need for additional visits to a physician’s office or to a hospital emergency room," testified David Spangler, SVP policy and general counsel & secretary for the Consumer Healthcare Products Association. "This availability especially benefits those asthmatics whose attacks are triggered by common environmental factors when immediate use may be essential. In addition, physician-diagnosed asthmatics who do not have easy access to medical care will continue to benefit from OTC use.”


- 1:57 PM
kesslerjjk@aol.com says

I do NOT understand this decision by the FDA. Primatene was on the market back when generic Ventolin / Proventil were still CFA and cost less than $10.00 for those insured. When they were forced to HFA, the cost to those insured soared to over $42.00 due the delivery and Primatene was forced off the market waiting HFA. Now it is HFA and FDA won't allow it back on the OTC market? The adverse events described in the article for only 3% is identical to those described for Ventolin / Proair, etc. Also, it has been my experience that physicians will no longer simply prescribe an inhaler. They insist on prescribing an asthma controller with it, such as Advair, Symbicort, etc. that are still branded and cost a lot, all with their own side effects to consider. Something just doesn't smell right about this decision.

- 1:16 PM
mjohnsen@lf1925.com says

An asthmatic myself, I can totally emphasize. However, note that the FDA has yet to make a decision on this. The agency to this point has only brought the issue to their advisory committees — which consist of doctors and healthcare experts in the relative field. And while the predominant thinking on the advisory committees cautioned against the safety profile of Primatene, the FDA has not yet made a final decision. The general rule of thumb is that the FDA follows the advise of its advisory committees, but that doesn't always hold true. For example, the FDA recently approved the switch of Merck's Oxytrol for Women from prescription-only to over-the-counter. However, the FDA advisory committees had some months before that approval recommended against the switch.

- 4:59 PM
Onetoknow says

I'm 54 I've been using primatine mist since it came out. It work every time 100 percent I've try all the new stuff nothing works as good as primatine mist Some body is getting paid off to keep this off the market think about all the money they are making now because u have to see a doctor. Greedy people

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