FDA gives “black box warning” against three asthma drugs

by Medindia Content Team on  July 14, 2005 at 8:03 PM General Health News   - G J E 4
FDA gives “black box warning” against three asthma drugs
Food and Drug Administration has given a "black box warning" to three asthma drugs, Foradil, Adavir and Serevent. The FDA panel has advised the manufacturers that the drug should carry clearly the warnings regarding the risks for worsened breathing.

Adavir and Serevent are manufactured by Glaxosmithkline, which contains a compound Salmeterol. Novartis manufacturers the drug Foradil which contains a different long-acting beta-agonist. The U.S. Advisory panel has advised Novartis that they should carry the warnings as mentioned by GlaxosmithKline in their drug Adavir and Serevent.

The resolution of the FDA panel said that consumers and doctors have to know more information about the potential risk of Foradil's. ``There is information that should come forward'' on potential Foradil risk, said Nancy Sander, an FDA panelist. FDA is reviewing the drugs and advising the pharmaceutical industries to provide more information to the consumers since the withdrawal of Vioxx painkiller of Merck & Co., from the market in September.

Asthma causes inflammation in the airways of the lung leading to lung muscle constriction leading to difficulty in breathing. Though, the FDA panel has approved the stay of Serevent, Adavir and Foradil in the market they insist the drugs should carry additional warnings. Advair and Serevent drugs were both combined with a corticosteroid for better treatment against asthma; the total sales of both these drugs were 2.5 million pounds (4.4 billion dollars).

SMART trial conducted in 1996 by Glaxo on their two drugs Serevent and Adavir was done as advised by FDA. The SMART trial was done with 26,000 recruits and the study was stopped in 2003 after about 50 people died or had severe life-threatening breathing complications after taking Serevent compared with placebo. In the study 20 black people had serious complications or died compared to 5 taking placebo. Though these results should not give misleading conception that blacks should not take the drug. These studies give a clear warning to the consumers about the drug. The pharmaceutical companies should give clear indications about the test results in a clearly understandable way by tabulating and by graphs.

Asthma patients should not stop taking their asthma medications without talking to their doctor. Abruptly stopping asthma medication can result in an asthma attack.

Research of Novartis has found a potential risk for worsened breathing with a higher dose of Foradil than the dosage allowed in the U.S., the FDA said in its review.

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