FDA Requires Warning Labels for Inhaled Asthma Products

The Food and Drug Administration (FDA) is requiring about a dozen inhaled and intranasal corticosteroids to bear a warning label that alerts health care providers and parents that use of these drugs in children may reduce their rate of growth. The label will also recommend using the lowest effective dose of these drugs and routinely monitoring patient's growth rates.

Controlled clinical studies have shown that inhaled and intranasal steroid products used to treat asthma may cause a reduction in growth velocity in pediatric patients. In studies involving the inhaled medications, the average rate of reduction in growth velocity was approximately 1 centimeter (1/3 of an inch) per year. FDA speculates that the reduction may be related to dose and how long the child takes the medication.

Effects on final adult height, or whether the patient's growth will "catch up" if treatment is discontinued are unknown.

Of course, these steroidal medications can be critical to the health, and even life, of the young patients who are taking them. Thus, FDA is strongly cautioning parents that they should not take their children off of these medications without first consulting with their pediatrician.

Echoing the FDA's caution are five physician groups, including the American Academy of Allergy Asthma and Immunology, the American College of Chest Physicians and the American Academy of Pediatrics, which point out that these inhaled steroid products are frequently the drug of choice in the treatment of asthma and may present far fewer side affects than long term use of oral formulations of these drugs.

These organizations are most concerned that undue attention to this one risk factor will be given too much weight by parents in deciding the best course of medical treatment for their asthmatic children.

By George Misko, Partner, Keller & Heckman Inquiries or comments may be sent to Mr. Misko at 1001 G St., N.W., Suite 500W, Washington, DC 20001; phone (202) 434-4100 or fax (202) 434-4646. E-mail: misko@khlaw.com

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