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No more Primatene Mist in the U.S. after this year
September 22nd, 2011
01:56 PM ET

No more Primatene Mist in the U.S. after this year

The Food and Drug Administration is reminding doctors and patients that Primatene Mist, the only nonprescription asthma inhaler in the United States, can no longer be sold or prescribed after December 31.   Asthma patients are urged to get prescriptions for alternative medications, since this treatment option runs out at the end of the year, the FDA said Thursday.

Primatene Mist, an epinephrine inhaler, made by Armstrong Pharmaceutical Inc., contains chlorofluorocarbons, a chemical known to deplete the ozone layer.   After the United States signed an international agreement - The Montreal Protocol on Substances that Deplete the Ozone Layer - to phase-out the compounds, the FDA announced in 2008,  that these inhalers could not be made or sold in 2012.

"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 Dr. Badrul Chowdhury, director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA's Center for Drug Evaluation and Research.

Chlorofluorocarbons are chemicals that contain fluorine, chlorine, and carbon. With inhalers, they are used as a propellant to move the medication, helping the user to breathe it in. According to The National Library of Science at the National Institutes of Health, once released, the odorless, colorless and nontoxic compounds get into the Earth's atmosphere where they break apart and release chemicals that destroy the Earth's ozone layer. CFCs can last more than 100 years in the atmosphere.

The FDA says a number of manufacturers have already replaced their CFC inhalers with a propellant called hydrofluoroalkane  or HFA, which is more environment-friendly, but there's currently no HFA version of an epinephrine inhaler available. Epinephrine is a hormone that's used to treat life-threatening allergic reactions. It opens up the airways in the lungs and allows patients to breathe more easily.

CFCs have been used in products like refrigerators, air conditioners, cleaning products and aerosols since the 1930s. Those products with CFCs were banned in the U.S. in 1995. They've been used in inhalers since the 1980s.

Chowdhury says asthma patients can continue using an inhaler that's not empty by the December 31 deadline as long as the expiration date is still good. He says HFA inhalers are safe and effective, but warns they may taste and feel different. "Talk with your health care professional to make sure you are using it correctly and getting the correct dose."

According to Chowdhury there are two prescription inhalers that still use CFCs. Those products are also part of the international agreement and they have phase-out dates of December 31, 2013.


soundoff (566 Responses)
  1. Cheech13

    Because they care:

    "During 2001–2009, the proportion of persons of all ages with asthma in the United States increased significantly (12.3%), from 7.3% (20.3 million persons) to 8.2% (24.6 million persons)."

    "a rising trend in asthma prevalence was observed for non-Hispanic black children (11.4% to 17.0%), non-Hispanic white women (8.9% to 10.1%), and non-Hispanic black men (4.7% to 6.4%)"

    "Prevalence among adults was greatest for women (9.7%) and adults who were poor (10.6%)"

    "rates disproportionately greater among children, women, blacks, and those reporting income below the federal poverty level"

    "More uninsured persons with asthma than insured could not afford to buy prescription medications (40.3% versus 11.5%), and fewer uninsured persons reported seeing or talking with a primary-care physician (58.8% versus 85.6%) or specialist (19.5% versus 36.9%)"

    "compared with those who had health insurance in the preceding 12 months, nearly four times the number of the uninsured persons with asthma were unable to buy prescription medication (40.3% versus 11.5%) and fewer reported seeing or talking with a primary care physician (58.8% versus 85.6%) or specialist (19.5% versus 36.9%) "

    "26.0% (3.2 million persons) reporting emergency department or urgent care center visits and 7.0% (850,183 persons) reporting having been admitted to a hospital. Thus, 13.6% (or nearly one in seven) of persons with asthma had an asthma attack that required urgent outpatient care."

    "The estimated total cost of asthma to society, including medical expenses ($50.1 billion per year)"

    "Similar to findings in previous studies (3–6), in 2009, asthma was more prevalent among children, women, non-Hispanic blacks, the poor, and in the Northeast and Midwest"

    http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6017a4.htm?s_cid=mm6017a4_w

    April 29, 2012 at 22:33 | Report abuse | Reply
    • Cheech13

      "The prevalence and number of persons with asthma have increased since 2001, and demographic differences among population subgroups persist despite improvements in outdoor air quality and decreases in cigarette smoking and secondhand smoke exposure (11–13). Although probable causes for the increase in asthma are unclear"

      Their groundbreaking conclusion:

      "Persons with asthma need to have access to health care and appropriate medications"

      My conclusion:

      "We have no idea what is going on but in the meantime see a doctor as often as you can and don't forget to load up on FDA sponsored drugs. Fresh patents, get em while they're hot." (certain social/financial requirements may apply, see front desk during regular business hours for details)

      April 30, 2012 at 00:22 | Report abuse |
  2. Cheech13

    Really, we do care. Honest:

    "there is no benefit of Primatene Mist over existing options"
    "Most people who use Primatene Mist do so out of convenience rather than financial need"

    Translation – Anyone saying it has helped them is either dumb or a liar. We know cause we're smarter than any of those lazy tightazz insured fakers.

    ARROGANCE

    April 30, 2012 at 00:39 | Report abuse | Reply
    • Cheech13

      "Many manufacturers have changed their inhalers to replace CFCs with an environmentally-friendly propellant called hydrofluoroalkane (HFA)" (FDA)

      "HFAs are ozone-safe propellants and are replacements for ozone-depleting CFCs in many sectors" (EPA)

      "Many manufacturers have switched the CFC in their inhalers with the environmentally friendly propellant called hydrofluoroalkane"

      "Since then, several manufacturers of prescription inhalers have converted their propellants to environmentally friendly hydrofluoroalkane"

      "HFA quick-relief albuterol inhalers are as effective and safe as CFC quick-relief inhalers, but are environmentally friendly." (Connecticut Pharmacists Association)

      "Asthma Inhalers to go Green at Year’s End with Eco-friendly Hydrofluoroalkane (HFA)" (blog.healia)

      Wow, won't be long now and you guys will have this planet back in top shape! Is this HFA some sort of wonder compound?

      April 30, 2012 at 07:39 | Report abuse |
  3. Cheech13

    Ummm, looks like you might have left something out – global warming potential gases??

    "the global warming potential is 1300 times higher for HFA-134a than for carbon dioxide"

    "HFA does not affect the ozone layer, but it exerts a significant effect on global warming, as it is one of the six greenhouse effect gases"

    "Though HFA is a non-ODS, it causes heat trapping in atmosphere and contributes to global warming. So, the Environment Protection Act (EPA) opposed the use of HFA in MDI's. Considering its essentiality and lack of a good alternative, the Kyoto Protocol (1997), a Conference on Greenhouse Gases, made following suggestions :
    i) Control of the production of HFA for the use of non-essential items.
    ii) No ban on the use of HFA in essential products such as MDI till an alternative substance is available for use."

    (good thing we told those Kyoto dudes to shove it)

    April 30, 2012 at 16:48 | Report abuse | Reply
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