From Our 2010 Archives

FDA Issues Warning on Key Asthma Drugs

By Steven Reinberg
HealthDay Reporter

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's 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. People 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 people should only require an inhaled corticosteroid to control their symptoms.

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

One expert said the announcements don't signal a radical departure for asthma care, although the recommendation to stop LABA use as soon as possible could bring problems for some.

"This could complicate care in certain settings," said Dr. Norman Edelman, chief medical officer for the American Lung Association. "This will require careful tailoring of treatment to individuals' disease and circumstance. Physicians should be aware of new guidelines and do so."

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 people whose asthma is not controlled by other drugs.
  • They should be used for the shortest time possible to bring asthma under control, and 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 the medications when combined with inhaled corticosteroids.

One industry representative said her company supported the FDA move.

"AstraZeneca supports the efforts of the FDA to share additional benefit/risk information within the product label and will work closely with the FDA to make the appropriate changes," said company spokeswoman Dana Settembrino. "AstraZeneca is confident in the positive benefit-risk profile of Symbicort, which has been demonstrated by extensive clinical trial data and through use by millions of patients worldwide."

Thursday's announcement follows 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.

Copyright © 2010 HealthDay. All rights reserved.

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; Norman Edelman, M.D., chief medical officer, American Lung Association; Dana Settembrino, spokeswoman, AstraZeneca





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