Data on effectiveness of morning sickness drug may be flawed

January 6, 2017

(HealthDay)—Pyridoxine-doxylamine (Diclectin), used to manage the nausea and vomiting associated with morning sickness, may not be as effective as once believed, according to a new analysis published online Jan. 4 in PLOS One.

Nav Persaud, M.D., and Rujun Zhang, M.D., from St. Michael's Hospital in Toronto, reviewed 36,000 pages of documents from the U.S. Food and Drug Administration, including an unpublished 1970s study and a summary of the results. The investigators also obtained other documents from Health Canada through freedom of information requests.

The original trial was done in 14 U.S. clinics among 2,308 women who experienced during their first 12 weeks of pregnancy. The women were randomly assigned to eight groups, one of which was given a placebo and the other seven a variety of drugs, including pyridoxine-doxylamine. Data from 1,599 women were analyzed. More rated the drugs as moderate or excellent, compared with those given a placebo. For pyridoxine-doxylamine, 14 percent gave it a moderate or excellent rating.

Persaud said the earlier study's data about the effectiveness of pyridoxine-doxylamine are shaky at best. "We found two main problems with the [unpublished] study. Data were missing for 31 percent of participants. There are questions about the integrity of the data," Persaud told HealthDay. "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 should be revisited."

Explore further: Unpublished research calls into question efficacy of common morning sickness drug

More information: Full Text

Related Stories

Pyridoxine-doxylamine drug safety data lacking

April 16, 2014

(Medical Xpress)—The most commonly prescribed drug for pregnant women suffering from morning sickness in their first trimester does not prevent birth defects even though drug safety data says it does, according to research ...

Recommended for you

Technique for 'three-parent baby' revealed

April 3, 2017

Details of a pioneering IVF technique using mitochondrial replacement therapy (MRT) have been revealed, giving hope to those families with inheritable mitochondrial disorders that they may be able to have healthy children ...

Technology to screen embryos before implantation falls short

March 31, 2017

The healthy development of an embryo created through in vitro fertilization (IVF) depends on whether most, if not all, of the cells have the proper number of chromosomes. With pre-implantation genetic screening (PGS) technology, ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.