FDA:
Over-the-Counter Asthma Inhalers Containing Chloroflouorocarbons (CFCs) Will No Longer Be Made or Sold After Dec. 31, 2011
SILVER SPRING, Md., Sept. 22, 2011 /PRNewswire via COMTEX/ -- Users of Primatene
Mist will need a prescription product to treat their asthma
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.