Drug maker faulted unfairly.(G.D. Searle and Co.)(Brief Article)

(Editor's note: The following appeared in the January 10 edition of USA Today.)

G.D. Searle, manufacturer of misoprostol, an anti-ulcer drug that has been used "off label" in conjunction with the abortion drug RU486, is receiving a great deal of unwarranted criticism for its efforts to protect patients.

Searle's efforts to clarify the labeling of its drug, at the request of the Food and Drug Administration [FDA] - - by revising the labeling and by sending a letter to warn doctors that the drug should not be used by pregnant women - - have led proponents of the RU486 abortion method, including USA TODAY and the FDA, to criticize Searle.

But there's good reason for Searle to worry about misoprostol (brand name Cytotec) when used outside its original purpose as an anti-ulcer drug. According to this month's issue of Mother Jones magazine, the off-label use of misoprostol to induce labor in pregnant women has resulted in 30 reported cases of uterine rupture in the past three years alone and eight cases in which the babies died in utero.

When misoprostol was first approved as an anti-ulcer drug, Searle stated that it was contraindicated for pregnant women.

The science on which this conclusion was based has not changed, and the incidences of uterine rupture resulting from off-label use have served to underscore the correctness of ...