Navigation Links
FDA Issues Warning on Key Asthma Drugs
Date:2/18/2010

Advair, Foradil, Serevent and Symbicort should not be used alone due to safety concerns,,

THURSDAY, Feb. 18 (HealthDay News) - A new label warning will caution users of four widely used asthma drugs to avoid using these medicines as a sole or long-term means of symptom control, the U.S. Food and Drug Administration announced Thursday.

The medicines are GlaxoSmithKline's Advair and Serevent, Novartis' Foradil and AstraZeneca's Symbicort. All are in the class of drugs known as long-acting beta agonists (LABAs). Serevent and Foradil are single-agent LABAs while Advair and Symbicort also contain an inhaled corticosteroid.

LABAs should no longer be used alone in treating adults and children, the FDA said. In making its decision, the agency cited studies that found that using the drugs alone can actually increase the severity of asthma, leading to hospitalizations and even death.

The drugs should only be used for the shortest time possible, until asthma symptoms are under control and be "discontinued, if possible, once asthma control is achieved," the agency said in a statement. Patients should then switch to another medication to maintain symptom control, the FDA said.

"We think the overall public health benefit is to reduce the use of LABAs," Dr. John Jenkins, director of FDA's Office of New Drugs in the Center for Drug Evaluation and Research, said during an early afternoon press conference Thursday.

"As we weighed the risks against the benefit of the drug, we recognized that there is still benefit for these products in patients who aren't adequately controlled on asthma controller medications," Jenkins said. "We wanted to maintain availability of these products, while also encouraging the safe use of the product."

According to Jenkins, most patients should only require an inhaled corticosteroid to control their symptoms.

LABAs work to improve a patient's breathing and reduce asthma symptoms by relaxing the lung's airway muscles.

The makers of the four drugs will have to add this information to their product labels:

  • These drugs must be used along with other asthma medications such as an inhaled corticosteroid.
  • The drugs should only be used in patients whose asthma is not controlled by other drugs.
  • They should be used for the shortest time possible to bring asthma under control, then other asthma drugs should replace them.
  • Children and adolescents who need these drugs should use only combination drugs that contain both a LABA and a corticosteroid.

Although the drugs are also approved for use in chronic obstructive pulmonary disease (COPD), this warning only applies to their use by asthma patients, the agency said.

In addition, the FDA is requiring that manufacturers of these drugs do more studies to determine the safety of these medications when combined with inhaled corticosteroids.

The announcement follows on an FDA advisory panel decision in December 2008. The panel found that the risks linked to single-agent Serevent and Foradil outweighed their benefits for children and adults. At the time, Advair and Symbicort were excluded from that decision.

More information

For more information on asthma, visit the U.S. National Institutes of Health.



SOURCES: Feb. 18, 2010, teleconference with: John Jenkins, M.D., director, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. The Ensign Group Reports Fourth Quarter 2009 Adjusted Earnings of $0.43 Per Share; Issues 2010 Guidance
2. One in Two Children Has Chronic Health Issues
3. New study suggests stem cells sabotage their own DNA to produce new tissues
4. American Red Cross Issues One-Month Progress Report for Haiti Earthquake
5. Majority of Americans Approve of President Obamas Handling of Afghanistan and National Security But Disapprove of Handling of Economic Issues, Per Franklin & Marshall College Poll With Hearst Television
6. FDA Issues Guidance to Help Streamline Medical Device Clinical Trials
7. Older female cancer survivors have added health issues compared to their counterparts
8. NVHR Issues Challenge to Administration, Congress: Dont Leave 5 Million Americans Afflicted with Chronic Viral Hepatitis Out in the Cold with Budget Freeze
9. Operation Rescues Advisory Board Issues Statement on Mr. Terrys Extremism
10. Greenfaith Ministry Calls on Churches & Doctors, to Address all Cannabis Issues and Regulation
11. School Support Lacking for Emotional, Behavioral Issues, say Parents
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... , ... Global Healthcare Management’s 4th Annual Kids Fun Run brought out many ... event, sponsored by Global Healthcare Management’s CEO, Jon Letko, is aimed at getting kids ... of all ages; it is a non-competitive, non-timed event, which is all about having ...
(Date:10/13/2017)... ... October 13, 2017 , ... “America On The Brink”: the ... “America On The Brink” is the creation of published author, William Nowers. Captain ... As a WWII veteran, he spent thirty years in the Navy. Following his ...
(Date:10/12/2017)... CITY, Fla. (PRWEB) , ... October 12, 2017 , ... ... cold therapy products, announced today the introduction of an innovative new design of the ... multipurpose pad so you get maximum comfort while controlling your pain while using cold ...
(Date:10/12/2017)... ... October 12, 2017 , ... HMP , a leader ... a 2017 Folio Magazine Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners were ... 11, 2017. , The annual award competition recognizes editorial and design excellence across a ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... property taxes a year. In some states—like New York, New Jersey, Massachusetts, Texas, ... many overseas retirement havens have extremely low property-tax rates, which contributes to the ...
Breaking Medicine News(10 mins):
(Date:9/25/2017)... Sept. 25, 2017   Montrium , an ... solutions, today—from the IQPC Trial Master Files & ... NL)—announced that EastHORN Clinical Services has selected ... and TMF management. EastHORN, a leading European contract ... to increase transparency to enable greater collaboration with ...
(Date:9/23/2017)... , Sept. 22, 2017 Janssen Biotech, ... complete response letter from the U.S. Food and Drug ... approval of sirukumab for the treatment of moderately to ... indicates additional clinical data are needed to further evaluate ... to severely active RA. ...
(Date:9/22/2017)... -- AVACEN Medical (AVACEN) announced that its CE-Marked AVACEN ... with the widespread pain associated with fibromyalgia in the ... Essex, England commented, "I had difficulty ... sleep at all, tremendous pain, with every movement sending ... AVACEN 100] enough, how this has and is helping ...
Breaking Medicine Technology: