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.
Some common questions and answers:
- When will epinephrine CFC inhalers be gone?
- What should I do if I use an epinephrine CFC inhaler?
- What if I don’t currently have a doctor or health professional who can write me a new prescription?
- What other inhalers can I use for my asthma?
- How are albuterol HFA inhalers and epinephrine CFC inhalers alike?
- How are albuterol HFA inhalers and epinephrine CFC inhalers different?
- The albuterol HFA inhalers may cost more than the epinephrine CFC inhalers. What can I do if it's hard for me to pay for an HFA inhaler?
- If I want to purchase health insurance, where can I go to find out what health insurance options I might currently have?
- I am having problems with my health insurance. Who can I contact?
- Why are over-the-counter epinephrine CFC inhalers being phased out?
- Has the FDA received an application for a CFC-free Primatene Mist replacement?
- Is it safe for epinephrine users to "purchase sufficient” amounts of Primatene Mist to use following the phase out date of December 31, 2011?
Epinephrine CFC inhalers, marketed as Primatene Mist, cannot be made or sold after December 31, 2011. This date gives patients time to talk to a doctor and switch to another medicine to treat their asthma.
If you use an epinephrine CFC inhaler for asthma, you should talk to a doctor or other health care professional about switching to a different medicine to treat your asthma. There is currently no over-the-counter or prescription epinephrine inhaler made without CFCs.
If you don’t have a doctor or health care professional (nurse practitioner, physician’s assistant) who prescribes medications for you, you can find one through a variety of ways:
- Ask a family member, friend, or coworker what doctor they use and would recommend
- Visit a federally-qualified health center, where patients pay to see a doctor based on their income and what they can afford. Visit http://findahealthcenter.hrsa.gov/Search_HCC.aspx to learn more or call 1-888-ASK-HRSA (888-275-4772)
- Visit a local clinic, community health center, or minute-clinic (sometimes located in a pharmacy)
There are inhalers that contain other medicines that can treat asthma, such as albuterol HFA inhalers. Hydrofluoroalkanes (HFAs) are different propellants (spray) than CFCs. You will need a doctor’s prescription to buy these.
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 (COPD).
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. The directions for use may be 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.
- 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. Contact the company that makes the drug that your health care professional prescribes.
- Visit free local clinics and public hospitals for additional assistance with your medications.
If you are interested in finding/purchasing health insurance, we encourage you to use the Plan Finder at http://finder.healthcare.gov. The Plan Finder will help you figure out what options might be available to you.
If you have concerns or questions about the insurance you currently have, you can find a list of resources on the HHS Consumer Assistance page at www.healthcare.gov/consumerhelp. If you do not have internet access and have questions about health insurance options, please call HHS at 888-393-2789.
Manufacturers use chlorofluorocarbons, or CFCs, as propellants (spray) in these inhalers to move the medicine out of the inhaler so patients can breathe the medicine into their lungs.
The United States signed an international agreement, called the Montreal Protocol on Substances that Deplete the Ozone Layer along with many other countries. These countries promised to make it illegal to make or sell substances that decrease the ozone layer, including CFCs, after certain dates.
The FDA cannot comment on the existence or status of pending drug applications.
Epinephrine users can use the product after December 31 because the product phase-out only applies to the manufacture and sale of the product after December 31.
If you haven’t used up your Primatene Mist by Dec. 31, 2011, 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. Individuals should always store the product as directed on the labeling, and it should be properly discarded when the expiration date is reached. Please reference the FDA's Consumer Update for additional information.
If you use an epinephrine CFC inhaler for asthma, you should talk to a doctor now about switching to a different medicine to treat your asthma.
Phase-Out of Epinephrine CFC Metered-Dose Inhalers Chlorofluorocarbon Containing Products No Longer Available After Dec. 31, 2011 FDA Drug Safety Podcast: Primatene Mist With Chlorofluorocarbons No Longer Available After Dec. 31, 2011[ARCHIVED]
Primatene Mist With Chlorofluorocarbons No Longer Available After Dec. 31, 2011
FDA Consumer Update article (3/16/2011)
Buying Prescription Medicine Online: A Consumer Safety Guide Montreal Protocol on Substances that Deplete the Ozone Layer Phase-Out of CFC Metered-Dose Inhalers