FDA SAYS WILL COMPLETE PHASE-OUT OF INHALER PRODUCTS CONTAINING CHLOROFLUOROCARBONS

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

The U.S. Food and Drug Administration will complete its phase-out of all inhaler medical products containing chlorofluorocarbons (CFCs) by Dec. 31, 2013. This effort is to comply with an international treaty to protect the ozone layer by phasing out the worldwide production of numerous substances, including CFCs, which contribute to ozone depletion.

While most inhaler products containing CFCs have already been phased out by the FDA, two products currently remain on the market: Combivent Inhalation Aerosol and Maxair Autohaler. However, these products will no longer be available after the end of this year. People with asthma or chronic obstructive pulmonary disease (COPD) who use these inhalers should talk to their health care professional about a prescription for an alternative treatment.

Inhalers are critical products for those persons suffering from asthma or COPD. In the United States, more than 25 million people suffer from asthma, a disease that affects the airways in the lungs and can cause coughing, trouble breathing, wheezing and tightness or pain in the chest. Additionally, 15 million people have been diagnosed with COPD, a serious lung disease that worsens over time. Symptoms can include chest tightness, chronic cough and excessive phlegm.

AGENT ORANGE STUDY OF POSSIBLE LINKS TO HYPERTENSION AND COPD

FROM: U .S. DEPARTMENT OF VETERANS AFFAIRS
The Army Chemical Corps Vietnam-Era Veterans Health Study is designed to learn if high blood pressure (hypertension) and some chronic respiratory diseases are related to herbicide exposure during the Vietnam War.

Background
This study follows a request by Secretary of Veterans Affairs Eric K. Shinseki for VA to conduct research on the association between herbicide exposure and high blood pressure (hypertension), as a basis for understanding if hypertension is related to military service in Vietnam.  VA is also interested in learning more about the relationship between herbicide exposure and chronic obstructive pulmonary disease (COPD).
This study is a follow-up of a similar study conducted between 1999-2000. We have examined the health status of individuals who served in the Army Chemical Corps since the 1990s.

Goals
Researchers have two questions:
Is the risk of high blood pressure (hypertension) related to Agent Orange exposure during service in Vietnam?
Is the risk of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, related to Agent Orange exposure during service in Vietnam?

Participants
Researchers are asking approximately 4,000 Veterans who served in the U.S. Army Chemical Corps sometime during the Vietnam era (1965-1973) to participate in this study.  Army Chemical Corps personnel were responsible for the maintenance and distribution or application of chemicals for military operations. Army Chemical Corps personnel who served in Vietnam during the Vietnam War constitute the largest group of Army Vietnam Veterans who were thought to have had the greatest potential exposure to herbicides.

We have already selected participants from earlier Army Chemical Corps study rosters, and researchers cannot accept volunteers for this study. Each Veteran selected for this study represents other Veterans with similar characteristics.

Methods
We are conducting telephone interviews, reviewing medical records, and measuring the blood pressure and lung function of these Veterans.

Investigators
Han Kang, Dr.P.H.
Aaron Schneiderman, Ph.D., M.P.H., R.N.
Yasmin Cypel, Ph.D.
Amii Kress, M.P.H.
Stephanie Eber, M.P.H.

HHS ON COPD

The following excerpt is from the Department of Health and Human Services website: 
HHS HealthBeat (March 30, 2012)
Breathing easy
More than 12 million Americans have been diagnosed with chronic obstructive pulmonary disease, or COPD. If you have COPD, you might experience constant coughing, excessive phlegm build up, and shortness of breath during normal activities.
Smoking is the most common cause of COPD. Air pollutants and respiratory problems also put you at risk.

Dr. Anne Wheaton is an epidemiologist with the Centers for Disease Control and Prevention.

"The most important thing is not to smoke. But if you are a smoker, smoking cessation—quitting smoking—is very important. Also, you can reduce exposure to air pollutants such as second hand smoke. And people who are exposed to dust, chemicals, or fumes at work should always use the proper protective equipment."