Most pregnant women — 74 percent, to be exact — experience nausea and vomiting commonly referred to as morning sickness (despite the fact it can happen all day). For the past 40 years, an estimated 35 million of them have been treated with a Kim Kardashian–endorsed prescription medication called Diclegis. However, a new study has raised questions about the drug’s efficacy.
As the Washington Post reports, the drug received pop-culture cred when Kardashian posted a promotional Instagram (and related tweet) in July 2015, writing, “OMG. Have you heard about this?” She said her doctor prescribed her Diclegis to help with her morning sickness, adding that the drug has “been studied and there was no increased risk to the baby.” But that August, the Food and Drug Administration ordered the post be taken down, saying it was “false and misleading” for not disclosing the drug’s risks. Kardashian later posted a “corrective” ad:
Now, a new study published in the journal PLOS One has brought the drug under further fire, the Post reports. Scientists in Toronto analyzed over 7,200 pages of data from clinical trials in the 1970s that hadn’t previously been made public. Lead study author Nav Persaud, a doctor and researcher at St. Michael’s Hospital, and his team looked at an old clinical trial that involved more than 2,300 patients at 14 clinics across the U.S., each of whom were split into eight randomized group.
The study had apparently been referred to as a success in medical literature, but Persaud found that the data had “unusual and striking” problems: Outcome data wasn’t available for 37 percent of the participants who were given placebos, and follow-ups weren’t conducted on 30 percent of patients, even though the trial only lasted a week.
“I’ve been looking into this [for the] last five years and found no good reason to prescribe this medication over others. Astonishingly, I’ve found the study that is supposed to be the basis of the claim this medication is effective is problematic,” Persaud told the Post.
A spokesperson for Duchesnay, which sells the drug in Canada (as Diclectin), told the Post that the medication’s two active ingredients are “the most studied drug combination used in pregnancy.” The spokesperson said in a statement, “We have complete confidence in the safety and efficacy of Diclectin and are very proud to provide it as a safe and effective treatment option for women suffering from nausea and vomiting of pregnancy.”