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Salmeterol does not appear to be teratogenic. (Preliminary Data).

NEW YORK -- The asthma drug salmeterol does not appear to be a major human teratogen, Dr. Kenneth Lyons Jones reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Data are preliminary, however. Researchers with the multicenter Organization of Teratology Information Services (OTIS) are seeking more asthmatic pregnant women for a prospective study called the Asthma Medications and Pregnancy Project, supported by Aventis Pharmaceuticals Inc.

Of approximately 900 women enrolled in the study before 20 weeks' gestation, 125 had been exposed to salmeterol at some point during pregnancy: 88% had used the long-acting [beta]-agonist during the first trimester, and 77% continued to use it into the third trimester.

Pregnancy outcomes in these women were compared with those of 91 asthmatic pregnant women who used only short-acting [beta]-agonists and with 115 nonasthmatic pregnant women.

Maternal characteristics, including age, ethnicity, pregnancy history, smoking status, and previous therapeutic and elective abortions, did not differ among the three groups studied, said Dr. Jones, who is chief of dysmorphology/teratology and professor of pediatrics at the University of California, San Diego.

There were no significant differences among groups in rates of spontaneous abortion, premature delivery, preeclampsia, infant length, head circumference, or proportions that were small for gestational age.

Major malformations were reported in 4.1% (5) of the salmeterol group, 2.6% (2) of the asthmatic controls, and 2% (2) of the nonasthmatic controls. These rates were not significantly different from each other or from the 3%-4% major malformation rate seen in the general population.

Of some concern, however, is the fact that four of the five major malformations in the salmeterol group were inguinal hernias (one bilateral and three unilateral). "The inguinal hernia thing is interesting. How that plays out when we get more numbers, I can't tell you," he remarked.

Asthma severity scores were slightly higher throughout pregnancy among the women in the salmeterol group than among the asthmatic controls, but this did not correlate with outcomes. About 75% of the salmeterol patients also used inhaled steroids during pregnancy, but controlling for steroid use did not affect the results.

More information about the OTIS is available at, or by calling 1-888-523-4847.
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Author:Tucker, Miriam E.
Publication:OB GYN News
Date:May 1, 2002
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