FDA to Primatene Users: Get Asthma Prescription Now

Sept. 22, 2011 -- The Primatene Mist inhaler is going away on Dec. 31, and prescription inhalers are the only alternative to the over-the-counter asthma drug.

Don't wait to get that prescription. The FDA warns that Primatene supplies may not last until the end of the year.

"All inhalers that might substitute require a prescription," the FDA's Andrea Leonard-Segal, MD, said at a news teleconference. "So those who use Primatene need to take action now to see a health care provider to get a replacement product." Leonard-Segal is the director of the FDA's division of nonprescription clinical evaluation.

"The clock is ticking on Primatene Mist, the only over-the-counter asthma inhaler," FDA press officer Karen Riley said at the news conference.

The problem with Primatene is that it contains chlorofluorocarbons or CFCs, which deplete the Earth's ozone layer. Environmental treaties signed by the U.S. banned products that emit CFCs. Most of these products already are gone. But medicines got a special extension.

That extension has expired for Primatene. Sales must end at the end of the year. Although the manufacturer of Primatene promises to come up with a version propelled by a safer chemical, the company has not yet done so.

This means that users of Primatene, which has epinephrine as its active ingredient, must switch to a prescription inhaler.

While prescription inhalers are safe and effective asthma drugs, they are different from epinephrine.

"I think patients will feel a difference," Leonard-Segal said.

"One person may feel a certain drug works better for them, but all FDA-approved drugs work in the populations for which they are approved," Sally Seymour, MD, deputy director for safety in the FDA's division of pulmonary, allergy, and rheumatology products, said at the news conference.

One difference users may feel is the price. A replacement cartridge of Primatene Mist sells for about $18. The albuterol inhalers sell for about $45 and up. However, patients with health insurance that covers prescriptions, and those covered by Medicare and Medicaid, may actually pay less for the drugs.

The FDA is not at all clear about how many Primatene users there are. Their best estimate is that 2 million Americans purchase 4 million Primatene units each year.

Here's the FDA's advice to Primatene Mist users:

• See a health care professional soon to get another medicine. Primatene Mist may be harder to find on store shelves even before Dec. 31, 2011.
• Ask your health care professional to show you how to use your new inhaler or other medicine to make sure you are using it correctly and getting the right dose.
• Follow the directions for using and cleaning your new inhaler or other medicine to make sure you get relief of your asthma symptoms.
• If you haven’t used up your Primatene Mist by Dec. 31, it’s safe to continue using it as long as it hasn’t expired. Check the expiration date, which can be found on the product and its packaging.