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Epinephrine CFC Metered-dose Inhalers - Questions and Answers

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Welcome to the Food and Drug Administration’s questions and answers on epinephrine CFC metered-dose inhalers.

I am Yolanda Fultz-Morris from F-D-A’s Center for Drug Evaluation and Research.

Epinephrine CFC metered-dose inhalers used to treat asthma, known as Primatene Mist or Epinephrine Mist, cannot be made or sold in the United States after December 31, 2011.

FDA is providing the following questions and answers to help you to better understand Epinephrine CFC metered-dose inhalers. Pat Clarke, from F-D-A’s Center for Drug Evaluation and Research will be providing the responses.

1. Why are over-the-counter epinephrine CFC inhalers being phased out?
Manufacturers use chlorofluorocarbons, or CFCs, as propellants, or sprays, in these inhalers to move the medicine out of the inhaler so patients can breathe the medicine into their lungs. CFCs are harmful to the environment because they decrease the protective ozone layer above the Earth.

The United States signed an international agreement along with many other countries. The agreement is called the “Montreal Protocol on Substances that Deplete the Ozone Layer.” These countries promised to make it illegal to make or sell substances that decrease the ozone layer, including CFCs, after certain dates.

2. When will epinephrine CFC inhalers be gone?
Epinephrine CFC inhalers cannot be made or sold after December 31, 2011, because CFCs harm the environment. This date gives patients time to talk to a doctor and switch to another medicine to treat their asthma.

3. What should I do if I use an epinephrine CFC inhaler?
If you use an epinephrine CFC inhaler for asthma, you should talk to a doctor about switching to a different medicine to treat your asthma. There is no other FDA-approved epinephrine inhaler made without CFCs or sold without a prescription.

4. What other inhalers can I use for my asthma?
There are inhalers that have another medicine that can treat asthma, such as albuterol HFA inhalers. Hydrofluoroalkanes,also called, HFAs, are different propellants, or sprays, than CFCs, and HFAs don’t harm the environment. You will need a doctor’s prescription to buy these albuterol HFA inhalers.

5. How are albuterol HFA inhalers and epinephrine CFC inhalers alike?          

  • Albuterol HFA inhalers are metered-dose inhalers that you use in the same way as you use the epinephrine CFC inhalers.
  • Albuterol HFA inhalers are safe and effective for these FDA approved uses: treatment or prevention of bronchospasm in patients with reversible obstructive airway disease, including asthma and chronic obstructive pulmonary disease, also called COPD. 

6. How are albuterol HFA inhalers and epinephrine CFC inhalers different?             

  • You can only buy albuterol HFA inhalers with a prescription from your doctor. You can buy epinephrine CFC inhalers without a prescription until December 31, 2011. After that date, epinephrine CFC inhalers cannot be made or sold in the United States.
  • Albuterol HFA and epinephrine CFC inhalers may taste and feel different.
  • You have to clean and prime the albuterol HFA inhalers so they work in the right way and give the right dose of medicine. 

7. The albuterol HFA inhalers cost more than the epinephrine CFC inhalers. What can I do if it's hard for me to pay for an HFA inhaler?

  • Talk to a healthcare professional about programs that help patients get medicines they need.
  • Some drug companies have patient-assistance programs that make medicines available to patients at no cost, or at a lower cost.
  • Some patients may be able to get help paying for medicines from the Centers for Medicare & Medicaid Services. 

8. Is it safe to buy albuterol HFA inhalers over the Internet?
Buying your medicine online can be easy; just make sure you do it safely. The Internet makes it possible to compare prices and buy products without leaving home. But when it comes to buying medicine online, it is important to be careful. Some websites sell medicine that may not be safe to use and could put your health at risk. For more information, please see our guide: Buying Prescription Medicines Online: A Consumer Safety Guide at  W-W-W dot F-D-A dot GOV slash D-R-U-G-S slash/R-E-S-O-U-R-C-E-S-F-O-R-Y-O-U slash U-C-M-0-8-0-5-8-8 dot H-T-M (http://www.fda.gov/Drugs/ResourcesForYou/ucm080588.htm)

Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site. W-W-W dot F-D-A dot GOV slash D-R-U-G-S.


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