From: lowry@watson.ibm.com (Andy Lowry)
Subject: Article on effects of ritodrine on premature births and mothers
Date: Thu, 30 Jul 1992 21:12:36 GMT
Disclaimer: This posting represents the poster's views, not necessarily those of IBM
Organization: IBM T.J. Watson Research Center

Copyright 1991 by UPI.
Reposted with permission from the ClariNet Electronic Newspaper
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	BOSTON (UPI) -- A drug frequently given to pregnant women who go into
labor prematurely does not boost a baby's chances of survival but could
pose health risks for the mother, researchers say.
	Although an estimated 100,000 pregnant women in the United States are
given the drug ritodrine annually to stop premature labor contractions,
there is no evidence the treatment helps them carry babies to full term
or reduces infant mortality, the Canadian scientists said Wednesday.
	At most, the drug reduces the number of women who deliver within 48
hours of the time they are hospitalized with uterine contractions, said
Dr. Jean-Marie Moutquin of Saint-Francois d'Assise Hospital in Quebec
City, Quebec, who led the study.
	Although a one- or two-day delay in delivery could benefit some very
premature infants, the women in the study who were given ritodrine had
increased rates of side effects such as heart palpitations, tremors and
chest pain, Moutquin and colleagues reported in The New England Journal
of Medicine.
	Consequently, the researchers said they do not recommend using
ritodrine for women 28 weeks or more into their pregnanciese unless
doctors need to delay delivery for a short time to give them time to
administer other drugs or to conduct diagnostic tests.
	The researchers compared 352 women given intravenous doses of
ritodrine to 356 others who received an inactive dummy drug. Altogether,
the women gave birth to 771 infants, including 63 pairs of twins.
	There was no difference between the two groups in infant mortality
rates, numbers of low-birth-weight babies or the number born before 37
weeks of gestation, Moutquin said.
	The only notable difference was a lower rate of delivery in the
ritodrine group within 24 hours to 48 hours of treatment, Moutquin said.
	``These results are generally in accordance with the conclusions of
previous trials of treatment of pre-term labor'' with ritodrine and
similar drugs known as ``beta-adrenergic agonists,'' he said.
	In an editorial accompanying the study, Drs. Kenneth Leveno and F.
Gary Cunningham of the University of Texas Southwestern Medical School
in Dallas said the results ``should greatly influence the treatment of
pre-term labor all over the world'' since ritodrine is used in at least
23 countries.
	The results should also prompt the Food and Drug Administration to
reconsider its approval of ritodrine use for premature labor, they said.
The FDA licensed the drug in 1980 amid criticism by researchers who
questioned its effectiveness and safety.
	Ritodrine is manufactured by Philips-Duphar of the Netherlands and
marketed in Canada by Brystol-Myers Canada. In the United States it is
sold under the brand name Yutopar by Astra Pharmaceutical Products Inc.
of Westborough, Mass.
	Dr. Nigel Rulewski of Astra said: ``We feel the study has shown what
we've known all along,'' namely that the drug can delay delivery long
enough for doctors to give additional treatment to a woman or transfer
her to a medical center with a neonatal intensive care unit.
	The company has never claimed that the drug can reduce infant
mortality or delay delivery to full term, but believes it can buy
valuable time for premature infants who are often born with lung
disorders that require specialized care, he said.
	Although no women died in the Canadian study, Leveno and Cunningham
said that in the 12 years the drug has been used, the incidence of one
maternal side effect known as pulmonary edema -- or excess fluid
accumulation in the lungs -- reportedly has been as high as 9 percent.
	Altogether ``between 3,000 and 9,000 pregnant women (in the United
States) may have pulmonary edema annually as a result of such therapy,''
they said, adding ``undoubtedly, some of them will die.''
	These estimates, together with the Canadian results and the fact that
the proportion of high-risk premature babies born at 3 pounds or less
has continued to rise ``compel us to ask that the FDA reappraise the
vanishingly small neonatal benefits'' of ritodrine in light of its
risks, they said.
	However, Rulewski said he believes the FDA will ``do just the
opposite.'' He said the agency has been criticized for not moving fast
enough to approve other drugs designed to halt premature labor.
	Given the risks premature babies face, Rulewski said he feels the
drug's benefits outweigh the drawbacks. ``We think it is very unlikely
the FDA will take action,'' he said.
--
Andy Lowry, lowry@watson.ibm.com, (914) 784-7925
IBM Research, P.O. Box 704, Yorktown Heights, NY  10598
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