Morning sickness is a common occurrence among 75 percent of pregnant women. At the same time, almost 1 percent experience a severe form known as hyperemesis gravidarum. In order to ease the symptoms, doctors usually recommend vitamins, and sometimes medication. A Canadian drug named Diclegis is the only medicine approved by the Food and Drug Administration, so popular that Kim Kardashian posted a promotional photo on her Instagram profile back in 2015. However, new research on the drug questions its efficacy.
The morning sickness drug originally designed in the mid-1950s and went by the name of Bendectin. It was composed of a combination of pyridoxine and doxylamine. Almost two decades later, a number of lawsuits surfaced claiming the morning sickness drug was linked to birth defects. Thirteen years later, Bendectin was withdrawn from the market, following crippling legal costs and falling sales.
However, according to Dr. Nav Persaud, an associate scientist, and physician at the Toronto-based St. Michael’s Hospital, the Duchesnay company starting selling the same mixture of active ingredients only a short time after Bendectin was pulled off the market, only this time under the name of Diclegis. Then, in 2013, the Food and Drug Administration approved the drug aimed at women experiencing morning sickness.
Even though Dr. Persaud claims vital information which could contain clues on the harmful side effects of the drug is missing from the original trials conducted in the 70s, the FDA stand by its verdict, deeming the morning sickness drug as highly efficient, as do many other health specialists.
After the team of researchers managed to obtain nearly 36,000 pages of information from the Food and Drug Administration on Diclegis, the scientists discovered that only about 7,000 were related to the drug. Furthermore, out of a 359-pages document obtained from Health Canada, roughly 200 were redacted.
Looking at the original trials the Bendectin was subjected to, the researchers also discovered that nearly 31 percent of pregnant women out of a total of 2,359 who enrolled in a weeklong study never completed the trial.
“This is a flaw, because the missing data could change the findings and conclusions depending on what happened to those women”, said Dr. Nav Persuad.
Ultimately, he also added that the final results of the trial were completely missing.
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