Asthma and COPD Inhalers That Contain Ozone-depleting CFCs to be Phased Out; Alternative Treatments Available

/PRNewswire/ -- The U.S. Food and Drug Administration today announced, in accordance with longstanding U.S. obligations under the Montreal Protocol on Substances that Deplete the Ozone Layer, seven metered-dose inhalers (MDI) used to treat asthma and chronic obstructive pulmonary disease (COPD) will be gradually removed from the U.S. marketplace. These inhalers contain ozone-depleting chlorofluorocarbons (CFCs), which are propellants that move medication out of the inhaler and into the lungs of patients. Alternative medications that do not contain CFCs are available.

The affected products and their phase out schedule include:

Last Date to be
                         manufactured, sold or
  Inhaler Medication     dispensed in U.S.      Manufacturer
  Tilade Inhaler
   (nedocromil)         June 14, 2010           King Pharmaceuticals
  Alupent Inhalation
   Aerosol                                       Boehringer Ingelheim
   (metaproterenol)     June 14, 2010            Pharmaceuticals
  Azmacort Inhalation
   Aerosol
   (triamcinolone)      Dec. 31, 2010           Abbott Laboratories
  Intal Inhaler
   (cromolyn)           Dec. 31, 2010           King Pharmaceuticals
  Aerobid Inhaler
   System
   (flunisolide)        June 30, 2011           Forest Laboratories
  Combivent Inhalation
   Aerosol (albuterol
   and ipratropium in                            Boehringer Ingelheim
   combination)         Dec. 31, 2013            Pharmaceuticals
  Maxair Autohaler                               Graceway
   (pirbuterol)         Dec. 31, 2013            Pharmaceuticals

Patients using the inhalers scheduled to be phased out should talk to their health care professional about switching to one of several alternative treatments currently available. Until then, patients should continue using their current inhaler medication.

CFCs are harmful because they deplete the ozone layer miles above the Earth that absorb some of the sun's harmful ultraviolet rays. The United States has banned the general use of CFCs in consumer aerosols for decades, and eliminated the production of CFCs in the United States as of Jan. 1, 1996, except for certain limited uses, such as MDIs.

"During this transition, FDA wants to ensure that patients have access to safe and effective alternative medications to treat their asthma or COPD," said Badrul Chowdhury, M.D., Ph.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in FDA's Center for Drug Evaluation and Research. "We are currently working with professional societies and patient organizations to make sure patients understand which products will no longer be available and have information on which alternative medication might work best for them."

The CFC phase out is part of an international agreement to ban substances that deplete the Earth's ozone layer. The Montreal Protocol on Substances that Deplete the Ozone Layer and the U.S. Clean Air Act aim to protect the public health and the environment from the potentially negative effects of ozone depletion. Bans on products containing CFCs began in the late 1970s.

The decision to phase out the products is the latest in a series of decisions related to the removal of CFC inhaler products from the market as required by the Clean Air Act. The agency proposed to phase-out the seven remaining products in 2007 and reached a final decision after reviewing more than 4,000 public comments and information submitted as part of a public meeting.

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Asthma Sufferers Breathe Easier as Walmart Announces $9 Environmentally Sustainable Inhaler

/PRNewswire-FirstCall/ -- As part of its continued commitment to provide accessible, affordable medications to those who need it most, Walmart today announced it will carry an environmentally friendly albuterol rescue inhaler starting at $9, the lowest-priced inhaler on the market. The ReliOn(R) Ventolin HFA inhalers, sold exclusively at Walmart*, will ease the transition as asthma sufferers are forced to replace their CFC-powered inhalers with new HFA inhalers in the new year to comply with an FDA mandate.

"While some HFA inhalers may sell for as much as $60 for certain brands, our $9 ReliOn Ventolin HFA inhaler will ease the financial burden for sufferers of asthma who should not go without these life-saving medications," said Sandy Kinsey, Walmart's divisional merchandise manager for pharmacy. "As an advocate for our customers, we're committed to ensuring they have access to affordable medicine they cannot live without."

According to the 2007 National Institutes of Health (NIH) asthma treatment guidelines, overuse of albuterol is a sign of uncontrolled asthma. With 60 metered inhalations, the ReliOn Ventolin HFA inhaler helps both patients and health care professionals monitor and track usage via the dose counter to identify overuse of albuterol. Additionally, it helps patients track how many puffs remain in their inhaler so they do not run out of their rescue medication when they need it most.

Walmart offers other affordable medications* for those suffering from the disease, including:

Albuterol 2mg tab $4 for 90 tablets $10 for 270 tablets
Albuterol 4mg tab $4 for 60 tablets $10 for 180 tablets
Albuterol 2mg/5ml syrup $4 for 120ml $10 for 360ml


For further information about Walmart's affordable prescription program, customers can visit http://www.walmart.com/pharmacy or discuss the program with their local Walmart, Neighborhood Market or Sam's Club pharmacist.

* Products and pharmacies are not available in North Dakota

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