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 The U.S. Food and Drug Administration (FDA) approved the drug,
pyridoxine-doxylamine (Diclegis, Diclectin), based on results from a
clinical trial. But previously unpublished data from the trial show
the drug worked no better than a placebo at reducing nausea and
vomiting in pregnant women, researchers report in PLOS One.
“I have stopped prescribing this medication,” said lead study author
Dr. Nav Persaud, a researcher and family physician at St. Michael’s
Hospital and the University of Toronto.
“Based on all the information available, I don’t think that it
works,” Persaud said by email.
For the current study, researchers analyzed findings from a
9,000-page clinical trial report from Health Canada that provided
more information about the medicine than results from the trial that
were published in 2010.
The 2010 report included 101 women who took the drug for two weeks
and 86 women who took a placebo, or dummy pill.
While these results suggested that the drug worked better than a
placebo, the current analysis found that this difference was too
small to be clinically meaningful for patients.
That’s because women rated nausea symptoms on a 13-point scale and
achieved only a 0.7-point greater reduction with the drug than with
a placebo. Unpublished records from the trial indicate that the drug
needed to achieve at least a 3-point greater reduction in nausea and
vomiting to be considered better than a placebo.
Health Canada and the FDA should revoke marketing approval for the
medicine, and until this happens doctors shouldn’t prescribe it,
Persaud and colleagues argue.
“It is surprising that the FDA and those who determine clinical
practice guidelines would make recommendations based on a single
clinical trial that lacks a robust conclusion of efficacy,” said Dr.
Marlena Fejzo, an obstetrician and gynecologist at the University of
Southern California and the University of California, Los Angeles,
who wasn’t involved in the study.
“Most patients do not take the decision of using a medication in
pregnancy lightly, and deserve to know that their provider is basing
their recommendations on a single study that had opposing
interpretations with respect to medication effectiveness,” Fejzo
said by email.
The drug was developed in the 1970s, and an older version of the
medicine was in use as far back as the 1950s. Early in 2017, Persaud
coauthored a re-analysis of a clinical trial from the 1970s; like
the current study, last year’s re-analysis found missing data and
called into question the effectiveness of the medication.
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Many doctors still consider the drug among their best options for
treating morning sickness and continue to prescribe it for women.
In December, in a practice bulletin published in Obstetrics &
Gynecology, the American College of Obstetricians and Gynecologists
(ACOG) reaffirmed its recommendation that doctors prescribe Diclegis
first before considering alternative medications to ease nausea.
ACOG is aware of the current study and still considers Diclegis to
be safe and effective for morning sickness, said Dr. Mark Turrentine,
chair of ACOG’s committee that drafted the nausea treatment
recommendations.
“If the U.S. Food and Drug Administration, the authors of the
original studies, or the drug manufacturer, correct or retract any
of the evidence used to develop ACOG’s guidance, we will reassess,”
Turrentine said by email.
Up to four in five pregnant women experience nausea, and half of
them endure vomiting and retching, ACOG notes in its practice
guidelines. The condition often peaks early in pregnancy, and can
ease without treatment, but in severe cases women can become
dehydrated and malnourished and require hospitalization.
Women may relieve symptoms by taking ginger capsules, wearing
acupressure wrist bands, or swapping their prenatal vitamins for a
supplement that contains only folic acid, ACOG advises.
Other drugs that ACOG recommends for morning sickness include:
dimenhydrinate (Dramamine, Gravol), diphenhydramine (Benadryl),
prochlorperazine (Compro), and promethazine (Phenergan). Pregnant
women are generally advised to check with their doctor before taking
any medication, however – especially in the first trimester.
SOURCES: http://bit.ly/2DIxnks PLOS One, online January 17, 2018,
and http://bit.ly/2DJv94f Obstetrics & Gynecology, online December
21, 2017.
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