Study Casts Doubt on Common Morning Sickness Drug

HealthDay Reporter

THURSDAY, Jan. 5, 2017 (HealthDay News) -- A drug commonly prescribed to ease the nausea of morning sickness may not be as effective as once believed, a new analysis suggests.

Diclectin (pyridoxine-doxylamine) has been prescribed for millions of pregnant women for years. But an unpublished study from the 1970s used by the U.S. Food and Drug Administration and Health Canada to approve the drug may have overstated its benefits, the Canadian researchers behind the new research said.

Study co-author Dr. Nav Persaud, a family physician at St. Michael's Hospital in Toronto, said the earlier study's data about the effectiveness of Diclectin is shaky at best.

"We found two main problems with the [unpublished] study. Data was missing for 31 percent of participants. There are questions about the integrity of the data," Persaud said.

"The approval and prescribing of this medication are based on this study. The decision to approve this medication should be revisited. The prescribing of the medication should be revisited," Persaud added.

However, one gynecologist who has been prescribing Diclectin for years thinks the new analysis adds nothing new about the drug's effectiveness.

"Women prescribed Diclectin should not be worried," said Dr. Mitchell Kramer, chairman of obstetrics and gynecology at Northwell Health's Huntington Hospital, in New York.

"The comments about the study are of no value," he said. "They will not alter my use of Diclectin, nor would I recommend people use this critique as a guideline."

Another gynecologist was less strident.

"The safety of Diclectin has been established, but there is a question about efficiency, so more studies are needed," said Dr. Jennifer Wu. She is an obstetrician/gynecologist at Lenox Hill Hospital in New York City.

According to Kramer, the two ingredients in Diclectin are pyridoxine, which is vitamin B6, and doxylamine, a sleep aid found in the over-the-counter medicine Unisom.

"Diclectin is very safe and effective for nausea and vomiting in pregnancy," he said.

The most common side effect is fatigue or sleepiness, but most people tolerate it very well, he said. "We prefer using it over some of the other anti-nausea medications," he added.

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