Kim Kardashian-Endorsed Morning Sickness Drug's Efficacy Questioned
Doctors are now questioning a drug that Kim Kardashian has endorsed in 2015. Diclegis, the drug in question, is intended to reduce the discomforts of morning sickness.
In 2015, a pregnant Kim Kardashian posted a photo on her Instagram page, showing a bottle of pills. She claimed it was effective and has "no increased risk to the baby", Washington Post reports. The photo has been deleted and changed into a "corrective" ad.
"I guess you saw the attention my last #morningsickness post received. The FDA has told Duchesnay, Inc., that my last post about Diclegis (doxylamine succinate and pyridoxine HCl) was incomplete because it did not include any risk information or important limitations of use for Diclegis," Kim posted on her Instagram page.
"Diclegis is a prescription medicine used to treat nausea and vomiting of pregnancy in women who have not improved with a change in diet or other non-medicine treatments. Limitation of Use: Diclegis has not been studied in women with hyperemesis gravidarum," she added.
Most pregnant women experience nausea and vomiting commonly referred to as morning sickness, though it could happen throughout the day. For the past four decades, an estimated 35 million have been treated with Diclegis, then known as Bendectin. However, health experts have questioned its efficacy and safety.
According to the new study in the journal PLOS One, there were problems and flaws in the clinical trial that the US Food and Drug Administration (FDA) and the federal department Health Canada used to approve the drug. Dubbed as the 8-way Bendectin Study, was not published in any scientific journal.
"I was surprised that there were so many serious problems with a study that forms the basis for approval and prescribing," Dr. Nav Persaud, a physician at St. Michael's Hospital in Toronto Canada who co-authored the study, said as reported by CNN.
"I have stopped prescribing this medication," he added.
Raw Data Contained Flaws
The old clinical trial on the drug, which has two main ingredients: pyridoxine and doxylamin, was conducted by Merrell-National Laboratories, which no longer exists today. More than 2,300 patients at 14 clinics took part in the trial. They were in their first 12 weeks of pregnancy who are experiencing the symptoms of morning sickness - nausea and vomiting.
According to Dr. Persaud, the study was never finished and has been dubbed a success despite lacking the important details. In fact, when they looked at the raw data of the trial, it has many flaws. For instance, outcome data was unavailable for 37 percent of the participants in the placebo group and approximately 30 percent of the participants were lost during follow-ups despite the fact that the trial lasted just a week.
Dr. Persaud urges the FDA, Health Canada and other medical groups to conduct a review of their own to determine the effectiveness of the drug. He added there are other alternative medicines for morning sickness that have undergone clinical trials and were published in journals.
What Is Morning Sickness?
Medical News Today reports that morning sickness, also called nausea gravidarum, is a common condition among 80 percent of all pregnant women. Nausea may be mild or severe to induce vomiting. Though there are medicines used to lessen the symptoms, natural remedies have also taken the spotlight as safe and effective treatment options for morning sickness.