KENILWORTH, N.J., May 31, 2000 /PRNewswire via COMTEX/ -- Millions of people
depend on small, pocket-sized devices called metered dose inhalers (MDI) to
deliver respiratory medications to their lungs.(1) For people with asthma,
chronic bronchitis and other respiratory conditions, MDIs are essential in
managing their illness. Ironically, most MDIs also deplete the earth's ozone
layer by releasing gases called chlorofluorocarbons (CFCs) into the atmosphere.
Research shows that, over time, these gases penetrate the ozone layer, allowing
ultraviolet rays to reach the earth. Although MDIs are responsible for only a
small portion of the ozone damage, the government has mandated that
pharmaceutical companies develop and bring to market CFC-free drug delivery
devices.(1)
"Over time, the presently available CFC MDIs used to treat asthma will be
replaced by CFC-free inhalers. In fact, CFC-free options are available today.
Patients need to understand why this change is taking place, how it may affect
their condition and what they can expect. Anyone who currently uses an MDI
should sit down with their physician to discuss this important issue," says
Bruce M. Prenner, M.D., associate clinical professor of pediatrics, USCD School
of Medicine, La Jolla, CA and founder of Allergy Associates Medical Group, Inc.,
San Diego, CA.
If you use a metered dose inhaler, or know someone who does, the following
questions may serve as a helpful discussion guide:
-- How long will my current MDI be available? Your current MDI will be
available until the U.S. Food and Drug Administration deems that there
are enough safe and effective alternatives available.
-- When will the new MDIs be available? Although the government would
like CFC-containing MDIs to be phased out as soon as possible, they
have no intention of banning existing MDIs until suitable alternatives
are available. To date, two replacement propellants have been
developed: hydrofluoroalkanes (HFAs) and hydrofluorocarbons (HFCs).
Neither has been shown to harm the ozone layer.(1) The first CFC-free
MDI, PROVENTIL(R) HFA (albuterol sulfate) Inhalation Aerosol, was
introduced in 1996 and is now approved for use in more than 25
countries, including the United States.
Additional CFC-free devices should be available by the year 2000.
-- Will the new MDI be as safe and effective as my old one? The new
CFC-free MDIs are designed to be therapeutically equivalent to the ones
they replace.(1) For example, in addition to being ozone-friendly,
PROVENTIL(R) HFA (albuterol sulfate) Inhalation Aerosol, has been shown
to be safe and effective, with consistently reliable dosing and
delivery.
-- Will the new MDI look/operate differently than my current device?
While new CFC-free MDIs are therapeutically equivalent to the ones they
replace, there may be minor differences in taste, spray force and the
shape of the mouthpiece. The basic operation of the new MDIs remains
the same.
-- Is this a new medication or just a new device? The new CFC-free MDIs
will be therapeutically equivalent to the ones they replace. In
addition to creating a new device, pharmaceutical companies must also
develop new formulations that will be compatible with the new
propellants. However, the active ingredients remain unchanged.
-- Is a delivery system that is compatible with my medication being
developed? If not, will I have to switch medication? All MDI
manufacturers are involved in developing CFC-free alternatives. The
existing CFC-containing MDIs are well tolerated and effective, and will
be available as long as they are essential for patient care.
-- Will there be any change in my condition during the switch? Although
there is no reason to anticipate a problem with your respiratory
condition during the switch, it is important to report any and all
changes you experience to your physician.
-- What, if any, CFC-free MDIs are available now? The first CFC-free MDI
is PROVENTIL(R) HFA (albuterol sulfate) Inhalation Aerosol. It is
safe, effective and ozone-friendly with consistently reliable dosing
and delivery.*
Make an appointment with your physician today to plan for a healthy tomorrow.
For more information about the MDI switch, including a free copy of the
brochure, "Your Metered Dose Inhaler Will Be Changing ... Here Are The Facts,"
call the National Asthma Education and Prevention Program (NAEPP), (301)
592-8573, or visit the website at http://www.nhlbi.nih.gov/index.htm.(1)
PROVENTIL(R) HFA (albuterol sulfate) Inhalation Aerosol is marketed by Key
Pharmaceuticals, a marketing unit of Schering-Plough Corporation, a
research-based pharmaceutical company engaged in the discovery, development,
manufacturing and marketing of pharmaceutical products worldwide.
Important Safety Information about PROVENTIL(R) HFA (albuterol sulfate)
Inhalation Aerosol:
If you find that your symptoms become significantly worse when you use
PROVENTIL(R) HFA contact your doctor immediately because this reaction can be
life threatening. Worsening symptoms frequently occur with the first use of a
new canister. Tell your doctor if you have a heart, blood or seizure disorder,
high blood pressure, diabetes, or an overactive thyroid.
Some medicines can interfere with how well asthma medications work. Tell your
doctor about all medicines you are taking, especially heart medicines and drugs
that treat depression.
In a clinical study, total adverse events reported were comparable to
traditional CFC-containing inhaled albuterol (upper respiratory tract infection
21% vs. 20%, rhinitis 16% vs. 22%, nausea 10% vs. 9%, tremor 7% vs. 8%,
nervousness 7% vs. 9%). Tachycardia (7% vs. 2%), vomiting (7% vs. 2%), chest
pain <3%, and palpitation <3% occurred more frequently with PROVENTIL(R) HFA.
(1) International Pharmaceutical Aerosol Consortium (Background Information).
* In a study, target dose was 108 mcg albuterol sulfate, USP equivalent to 90
mcg of albuterol.
