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Home » Adolescents, Asthma, Children's Health, Drugs, FDA

Experts Say Popular Asthma Drugs Are Too Dangerous For Children

Submitted by MedHeadlines on 6 December, 2008 – 10:23One Comment

Some of the most popular prescription drugs for treating asthma may be too dangerous for children under the age of 18, according to a panel of experts.  Some of them are thought to be too dangerous for use in adults, too.

Advair and Serevent (made by GlaxoSmithKline), Symbicort (AstraZeneca), and Foradil (Novartis AG and Schering-Plow) are all inhaled long-acting beta agonist drugs (LABAs), which deliver long-lasting relief from asthma symptoms, but a US Food and Drug Administration (FDA) advisory panel has recommended the agency revoke approval of these drugs due to their tendency to provoke asthma attacks that increase the risk of death to patients taking them.

Of particular concern is the danger these drugs pose to asthmatic children although the panel urged the FDA to revoke its approval of Serevent and Foradil for asthma patients of every age.  These two drugs contain only LABAs but Advair and Symbicort combine LABAs with a steroid.   The presence of the steroid is thought to provide a degree of protection that offsets the risk of the LABAs.

The decision to extend approval or revoke it is expected to come after the panel meets next week.  Dr. Badrul Chowdhury says that while these drugs pose a “serious and significant safety risk,” they produce benefits that are “not trivial” and they do so with a risk of asthma-related death described as “numerically small.”  Chowdhury is director of the FDA division that reviews the safety of drugs approved for pulmonary and allergy conditions.

Chowdhury further states removing these inhaled LABAs is an “extreme approach” to managing the risks these drugs pose and doing so may prove “problematic.”  Even if approval as asthma treatment is revoked, the drugs will still be available for treating chronic obstructive pulmonary disease (COPD).

The drug companies are expected to present evidence at next week’s meetings that prove that, when taken as directed, the benefits outweigh the risks associated with these drugs.

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