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FDA Requires Asthma Inhaler Changes

Metered Dose Inhaler (MDI)Albuterol metered dose inhalers (MDIs), also called “short-acting” or “rescue” inhalers, are made by several manufacturers. They have traditionally used chlorofluorocarbons (CFCs) to “propel” the albuterol into the lungs. But now, a new safe and effective alternative propellant, hydroflouroalkane (HFA), has been created to replace CFCs, and will become the required standard for all inhalers starting in 2009. (See official FDA announcementto learn more.)

You don’t have to wait until 2009 to make the switch, you can do it today. Many HFA albuterol inhalers are already available. Talk to your doctor today about writing a new prescription for an HFA inhaler and make the switch early so you'll make the 2009 deadline. Between now and December 31, 2008, CFC inhaler production will begin to be phased-out. But as the supply of CFC inhalers decreases, supplies of HFA inhalers will increase to ensure that the total supply meets the total patient demand, up to and beyond the 2009 required transition date.

HFA albuterol and levalbuterol medications currently available include:

  • Proventil-HFA (NDC 00085-1132-01) from Schering-Plough
  • Ventolin-HFA (NDC# 0173-0682-00) from GlaxoSmithKline
  • ProAir-HFA (NDC 59310-579-20) from Teva
  • Xopenex-HFA (NDC 63402-510-01) from Sepracor

Talk to your doctor today about writing a new prescription for an HFA inhaler and make the switch early. 

Frequently Asked Questions

Q1. What is the difference between my CFC inhaler and the new HFA inhalers?
A1. CFC albuterol inhalers contain chlorofluorocarbons, which harm the ozone layer. Replacements of CFCs have been available since 1996, and are known as HFAs (hydrofluoroalkanes). HFA inhalers provide the same level of safety and efficacy as CFC inhalers, but without harming the ozone layer. There may be a few differences with HFAs in taste and/or feel.

Q2. Why do I need to switch my CFC inhaler for a new HFA inhaler?
A2. CFCs have been taken out of almost every product since 1978 because it has been discovered that CFCs harm the environment by destroying the Earth’s protective ozone layer. However, under the Montreal Protocol in 1987, countries have been permitted to use CFCs for certain medical uses, such as for asthma inhalers, until safe and effective alternatives have been created. Now, with HFAs available as a safe and effective alternative, a full transition can be made, even for asthma inhalers.

Q3. When will CFC inhalers be phased-out, and HFA inhalers phased-in?
A3. Some CFC manufacturers have already begun to stop making CFC inhalers and more and more companies have begun to make HFA inhalers. By 2008 all CFC inhalers will be phased-out and HFA inhalers will he fully phased-in.

Q4. How can I get my new HFA inhaler?
A4. You will need to get a new prescription from your doctor for an HFA inhaler, so consult with your doctor to determine which HFA albuterol inhaler is right for you. Your doctor can also help establish the timing and manner of your personal transition to an HFA inhaler. You will not be able to just exchange your current CFC inhaler prescription for an HFA inhaler at the pharmacy; a new prescription from your doctor will be required.

Q5. Will my new HFA inhalers be as safe and effective as my CFC inhaler?
A5. Yes! HFA inhalers have been available since 1996 and provide the same level of safety and efficacy as CFC inhalers, but without harming the environment.

Q6. If I want to keep my CFC inhaler, but can’t find it at the pharmacy, what should I do?
A6. First, use this as an opportunity to schedule a visit with your doctor to discuss your personal transition to an HFA inhaler. After December 31, 2008, you will be required to use an HFA inhaler anyway, so make the transition early. If you want to continue using a CFC inhaler before the required transition date, supplies will be limited since most companies will be making HFA inhalers. Check with the pharmacy benefits manager of your health plan to find a pharmacy in your area that may have some CFC inhalers left, but also schedule a visit with your doctor to eventually get your first HFA inhaler before the deadline date. 

Q7. How much will HFA inhalers cost?
A7. HFA inhaler cost will depend on a number of things, including your medical plan, co-pay policies and insurance status. Manufacturers of the HFA products are implementing programs to make sure those who cannot afford HFA inhalers will be able to get them. These programs include giveaways, coupons for reducing the price paid, and patient-assistance programs based on financial need.

Q8. How do I know if I qualify for financial aid or HFA inhaler giveaway programs?
A8. HFA inhaler manufacturers are offering patient-assistance programs. For information contact: Schering-Plough’s SP Cares1-800-656-9485, GlaxoSmithKline’s GSK For You 1-866-GSK-4YOU, or Teva Consumer Hotline 1-800-445-2455. Find information on
patient assistance programs online. 

Q9. Where else can I get information on the inhaler transition?
A9. The FDA has more information available on the
inhaler transition online. 

 
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