For many women, pregnancy is one of those magical times full of excitement. Unfortunately, pregnancy also doles out one particular unpleasant side effect to many moms to be — morning sickness. Morning sickness is one of the more common side effects of pregnancy and impacts an estimated 75% of women. About 1% of women experience morning sickness symptoms so severe that they develop hyperemesis gravidarum and require hospitalization. Fortunately, because morning sickness is so common, there are options available to help ease the unpleasant side effects of nausea and vomiting.
Diclegis, the only prescription medication approved by the FDA to combat the effects of morning sickness, has been used by women across the country. Its effectiveness has even compelled stars, like Kim Kardashian, to use the products and promote it on their social media pages. However, a new paper may be impacting the medication’s popularity in the near future.
According to a new paper that was recently published in the journal PLOS One, there were “flaws in the clinical trial that the FDA and Health Canada used to approve the drug, then known as Bendectin.” According to industry professionals, including Dr. Nav Persaud “a physician and associate scientist at St. Michael’s Hospital in Toronto and assistant professor at the University of Toronto,” the trial, otherwise known as the 8-way Bendectin Study, was never actually published in a scientific journal. He would know since he co-authored the new controversial paper and actually did much of the research behind the new findings. Based on the drug’s information, or lack thereof, he’s stopped prescribing Diclegis to his pregnant patients altogether, saying, “I was surprised that there were so many serious problems with a study that forms the basis for approval and prescribing.”
How was this huge flaw found, though? Well, Persaud and his fellow researchers reviewed nearly 36,000 pages of information gathered from the FDA, of which about 7,200 were related to the clinical trial. An estimated 359 pages of information were also gathered from Health Canada, though 212 of those pages were redacted. Using the commonly used Cochrane Risk of Bias tool, they assessed the quality of the clinical trial and found that out of “2,359 patients who initially enrolled in the weeklong trial, 31 percent never completed it.” According to Persaud and his fellow researchers, “this is a flaw because the missing data could change the findings and conclusions depending on what happened to those women.” Further research revealed that parts of the final clinical trial results were also missing.
In response to the sudden controversy, the pharmaceutical company behind the drug, Duchesnay Inc., has come out on the defensive, claiming that the safety and efficacy of Diclegis have been proved over the years and in other “more recent studies and meta-analyses.” The FDA and other experts are also defending the medication, calling it “safe and effective.”
Not everyone is convinced, though, and some researchers warn against using the drug altogether, saying, “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.”
So how do we move forward? For now, Persaud and other physicians and experts are recommending mothers to be to discuss treatment options with their doctor. There are many natural remedies to morning sickness that women can try before resorting to medication, such as grazing throughout the day, drinking plenty of fluids, and eating dry toast and crackers. The most important thing is to stay informed and never take medication you don’t feel comfortable with taking.