The U.S. Food and Drug Administration says users of epinephrine
inhalers containing chlorofluorocarbons (CFCs) should plan now to get a
prescription for a replacement product because these inhalers will not
be made or sold after Dec. 31, 2011.
Epinephrine inhalers,
marketed by Armstrong Pharmaceutical Inc. as Primatene Mist, are the
only FDA-approved inhalers for the temporary relief of occasional
symptoms of mild asthma that are sold over-the-counter in retail stores
without a prescription. The product uses CFCs to propel the medicine out
of the inhaler so that consumers can breathe it into their lungs.
However,
Primatene Mist will no longer be available by year’s end because no
CFC-containing epinephrine inhalers can be made or sold after Dec. 31,
2011, to comply with obligations made under the Montreal Protocol on
Substances that Deplete the Ozone Layer. This is an international
agreement signed by the United States, in which countries agreed to
phase-out substances that deplete the ozone layer, including CFCs, after
certain dates.
“If you rely on an over-the-counter inhaler to
relieve your asthma symptoms, it is important that you contact a health
care professional to talk about switching to a different medicine to
treat your asthma,” said Badrul Chowdhury, M.D., director of the
Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s
Center for Drug Evaluation and Research.
The FDA began public
discussions about the use of CFCs in epinephrine inhalers in January
2006. The FDA finalized the phase-out date for using CFCs in these
inhalers and notified the public in November 2008. Many manufacturers
have changed their inhalers to replace CFCs with an
environmentally-friendly propellant called hydrofluoroalkane (HFA).
There is currently no HFA version of epinephrine inhalers.
There
are, however, many other safe and effective inhalers to treat asthma
symptoms. All of these inhalers require a prescription, which must come
from a licensed health care professional (physician, physician’s
assistant or nurse practitioner). Current epinephrine inhaler users that
don’t have a health care professional to write them a new prescription
can ask a family member or friend what doctor they use and would
recommend, or they can visit a federally-qualified health center, local
clinic, community health center, or minute-clinic (sometimes located in
pharmacies) to see a health care professional and get a prescription.
Primatene
Mist already carries a prominent notice about the phase-out date on its
product label, and the FDA encourages Armstrong Pharmaceutical to
further educate consumers as the deadline approaches to ensure an
incident-free transition. The agency also will continue to work with
retailers and pharmacies to facilitate a smooth phase-out of this CFC
product and is prepared to review applications for replacement products.
