HORSHAM, Pa.--(BUSINESS WIRE)--According to the United States (U.S.) Food and Drug Administration (FDA), the only over-the-counter (OTC) asthma inhaler containing chlorofluorocarbons (CFCs), Primatene® Mist, will be removed from the U.S. market on or by December 31, 2011. The removal of Primatene® Mist by the FDA is a result of the Montreal Protocol treaty to stop the use of substances that damage the environment. Primatene® Mist contains CFCs, which harm the environment by depleting the earth’s ozone layer. As a result of the removal of Primatene® Mist from the market, patients will need to see a healthcare professional to switch to another asthma medication. To help patients in this transition, Teva Respiratory is supporting patients through several programs, including financial assistance programs, asthma product samples available through healthcare professionals and asthma education resources.
With the Primatene® Mist withdrawal quickly approaching, the FDA is encouraging patients to see a healthcare professional to switch to another asthma medication. To assist patients through the transition, Teva Respiratory is making asthma product samples for ProAir® HFA (albuterol sulfate) Inhalation Aerosol (quick-relief albuterol inhaler) and for QVAR® (beclomethasone dipropionate HFA) Inhalation Aerosol (asthma control inhaler) available to patients through healthcare practitioners. Access to ProAir® HFA and QVAR® samples through healthcare providers is critical to ensuring patients will have the appropriate treatment they need for a smooth transition. In addition to product samples, Teva Respiratory is offering financial assistance to qualifying patients through the Teva Assistance Program, which provides free ProAir® HFA and QVAR® inhalers. Additional information on the Teva Assistance Program and program forms can be accessed through the Resources section of the ProAir HFA website, www.ProAirHFA.com. Patients and healthcare providers can also call the toll-free Teva Assistance Program line at 1-877-254-1039 for more information. Teva Respiratory is also increasing the amount of asthma education resources available to aid in the transition. These patient education resources are available through healthcare providers, as well as online at www.ProAirHFA.com.
Asthma rates in the U.S. continue to rise with an estimated 25 million people, or nearly 10 percent of the population currently diagnosed with asthma. The impact of asthma in the U.S. is substantial, resulting in approximately two million emergency department visits, 14 million lost work days, and almost 11 million lost school days per year. “As asthma rates are constantly increasing in the U.S., it’s important for people to understand the importance of speaking with their healthcare professionals so that they can be evaluated and potentially treated for this chronic disease,” said Paul Dorinsky, M.D., Vice President, Teva Global Respiratory Research and Development. “For patients with persistent asthma, national guidelines and the FDA recommend using both a quick-relief HFA inhaler to alleviate acute symptoms and a long-term control inhaler daily.”
“As a leader in the respiratory space, Teva Respiratory is committed to providing valuable patient assistance programs to ensure asthma patients have access to treatment options, and along with their healthcare professional, are properly treating and managing their condition,” said Mark Salyer, Executive Vice President and General Manager, Teva Respiratory, LLC. “
For more information on patient resources available from Teva Respiratory, please visit www.ProAirHFA.com or www.QVAR.com
About Asthma
Asthma is a chronic (long-term) disease of inflammation of both the large and small airways of the lung, characterized by symptoms of wheezing and coughing. Asthma causes recurring periods of wheezing (a whistling sound when you breathe), chest tightness, shortness of breath and coughing that often occurs at night or early in the morning. Without appropriate treatment, asthma symptoms may become more severe and result in an asthma attack, which can lead to hospitalization and even death.
About ProAir® HFA (albuterol sulfate) Inhalation Aerosol
ProAir® HFA (albuterol sulfate) Inhalation Aerosol is indicated in patients 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.
Important Safety Information
If your symptoms become significantly worse when you use ProAir® HFA, contact your doctor immediately. This may indicate either a worsening of your asthma or a reaction to the medication, which may rarely occur with the first use of a new canister of ProAir® HFA. Either of these could be life-threatening.
What to tell your doctor before using ProAir® HFA: If you have a heart, blood, or seizure disorder, high blood pressure, diabetes, or an overactive thyroid, be sure to tell your doctor. Also make sure your doctor knows all the medications you are taking – especially heart medications and drugs that treat depression – because some medications may interfere with how well your asthma medications work. Do not exceed the recommended dose.
Side effects associated with ProAir® HFA included headache, rapid heart beat, pain, dizziness, and irritation of the throat and nose.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
About QVAR®
QVAR® is indicated in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age or older. QVAR® is also indicated for asthma patients who require systemic corticosteroid administration, where adding QVAR® may reduce or eliminate the need for systemic corticosteroids.
Important Safety Information
QVAR® does not replace fast-acting (rescue) inhalers for sudden symptoms.
CAUTION: If you are switching from an oral corticosteroid to QVAR®, follow your doctor's instructions to avoid health risks when you stop using oral corticosteroids (See WARNINGS, Prescribing Information).
Inhaled corticosteroids may cause a reduction in growth rate. The long-term effect on final adult growth is unknown.
In clinical studies, common side effects included headache and pharyngitis.
Do not stop taking QVAR® abruptly without talking to your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
QVAR® is a registered trademark of IVAX LLC, a member of the Teva Group.
For full prescribing information, please click here: http://www.qvar.com/PrescribingInformation.pdf
About Teva Respiratory
Teva Respiratory is the U.S.-based respiratory subsidiary of Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA). Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's largest generic drug maker, with a global product portfolio of more than 1,300 molecules and a direct presence in about 60 countries. Teva's branded businesses focus on neurological, respiratory and women's health therapeutic areas as well as biologics. Teva currently employs approximately 42,000 people around the world and reached $16.1 billion in net sales in 2010.
If your symptoms become significantly worse when you use ProAir® HFA, contact your doctor immediately. This may indicate either a worsening of your asthma or a reaction to the medication, which may rarely occur with the first use of a new canister of ProAir® HFA. Either of these could be life-threatening.
What to tell your doctor before using ProAir® HFA: If you have a heart, blood, or seizure disorder, high blood pressure, diabetes, or an overactive thyroid, be sure to tell your doctor. Also make sure your doctor knows all the medications you are taking – especially heart medications and drugs that treat depression – because some medications may interfere with how well your asthma medications work. Do not exceed the recommended dose.
Side effects associated with ProAir® HFA included headache, rapid heart beat, pain, dizziness, and irritation of the throat and nose.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.