A recent unpublished study now raises questions about the efficacy that the most prescribed drug used to avoid morning sickness has in pregnant women.
The name of the drug is Diglesis (Dicleclin in Canada) and is the only drug that is approved by the Food and Drug Administration Office. Even Kim Kardashian endorsed the medicine back in 2015 in an Instagram post.
The new study says that in the 1970s, when both the FDA and the Federal Department of Health from Canada approved the drug, there were a series of flaws that invalidate the approval.
Physician and associate scientist at St. Michael’s Hospital in Toronto and assistant professor at the University of Toronto, Dr. Nev Persaud, says that the official results of the test, conducted by the now extinct Merrel-National Laboratories, were never actually published.
How the study questions the drug
In the paper published this Wednesday in the PLOS One journal, the research team formed by Dr. Persaud and other experts, says that there cannot be a drug in which the tests that were made regarding its approval are so full of flaws.
The investigation team used the Cochrane Risk of Bias Tool, to determine if the consent was, in fact, valid. They reviewed over 37,000 pages of official information published by the FDA and the Canadian Health Department while also analyzed the test used at the time, which was called the 8-way Bendectin Study.
The research team found that from the first 2,359 patients that were enrolled in the one-week length trial, up to 31 percent of them did not stay until the end of the test.
“This is a flaw, because the missing data could change the findings and conclusions depending on what happened to those women. The questionable data integrity, high drop-out rate, and other methodological concerns mean that the prescribing of this medication should not be based on this trial,” Dr. Persaud noted in the paper published this Wednesday.
The FDA stated that that test conducted so many years ago is not the only evidence that they used to approve the Diglesis drug. According to a spokeswoman for the federal agency, there have been more recent studies that prove how the drug helps pregnant women to overcome morning nausea and vomiting.
Also, the Canadian Health Department published an official statement last year saying that the drug’s efficacy “have been proven in 16 cohort studies, two meta-analyses, an ecological study, a neurological development study and numerous others.”
The American Congress of Obstetricians and Gynecologists and the Association of Professors of Gynecology and Obstetrics still consider the Diglesis drug as the most safer and effective drug to combat this complaint, when the most conservative medicine methods fail.
According to official data from the Health Department of Canada, over 35 million women worldwide use the doxylamine succinate and pyridoxine hydrochloride combination, as it has been proved as the most efficient way to struggle with this illness that affects about 75 percent of pregnant women across the world.