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Recalled Asthma Inhalers
May Be Linked to Deaths

WASHINGTON, August 10, 2001 -- A consumer watchdog group says asthma inhalers recalled by Schering-Plough Corp. are the "primary suspect" in the deaths of 17 asthma patients that occured from late 1998 through early 2001.

Schering-Plough has recalled albuterol inhalers distributed during that time period because of a manufacturing problem that could have caused some of the inhalers to contain no active ingredient. The manufacturer insists that possibility is "remote."

The Public Citizens Health Research Group said that at least 10 of those who died were attempting to use the inhalers that were later recalled. Albuterol is used in "emergency" inhalers which asthma patients use when they are having an attack. Other inhalers are used on a preventive basis.

Public Citizen said its study of Food and Drug Administration (FDA) records indicated that asthma deaths spiked during the time that the recalled inhalers were being distributed and called for a criminal investigation to determine whether Schering-Plough knowingly shipped defective inhalers.

In a letter to Tommy Thompson, Secretary of Health and Human Services, Public Citizen said remarks in FDA reports clearly indicate there were problems with albuterol inhalers during the time the recalled units were in use.

The remarks included those of a 21-year-old, shortly before his death, who “complained on several occasions that his albuterol inhaler did not seem to treat his asthma attacks as usual”. A ten-year-old boy who had an asthmatic attack “reached for his inhaler and obtained no relief” and died shortly thereafter.

"Both of these people were using inhalers from the recalled lots. Of those who died whose ages were known, six were under the age of 30 including three who were less than 20 (10, 12, and 16)," said Sidney M. Wolfe, MD, Director, Public Citizen’s Health Research Group.

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