Although the FDA panel concluded that there were no association between Bendectin and birth defects 13 , and despite that no known association between the use of Bendectin and birth defects was established in any of the legal cases, Merrell Dow Pharmaceuticals ceased production of Bendectin worldwide in , as their soaring legal and liability insurance costs eclipsed sales. In addition to the FDA, other national health agencies responsible for drug safety Canada, UK, Australia, Germany and Switzerland had reviewed the scientific evidence on Bendectin safety and had issued public statements indicating that the evidence did not demonstrate a connection between the use of Bendectin during pregnancy and birth defects.
Following unsuccessful settlement discussions, the case went to the jury which ruled in the company's favor. The verdict was upheld on two appeals. In the late s, following scientific fraud complaints against Dr.
William Griffith McBride, he was convicted of scientific fraud and ultimately struck in from the Australian Register of medical practitioners for deliberately falsifying data. McBride is the Australian obstetrician and gynaecologist who took the stand in the s as an expert witness in several highly publicized U.
The seminal U. Supreme court case involving Bendectin is Daubert v. Merrell Dow, U. In that case, plaintiffs alleged that Bendectin - which had been manufactured by Merrell Dow Pharmaceuticals, Inc. Plaintiffs' experts, through what was ultimately deemed to be "junk science", failed to present any study in support of plaintiffs' theory that Bendectin could cause malformations in human fetuses. McBride had been on of the plaintiffs' expert witnesses.
Two separate meta-analyses were published by Einarson et al in 12 and by McKeigue et al in 15 , which included over , pregnancies exposed and control groups. Neither analysis observed an increased risk for major malformations. Separate analyses were conducted for specific defects, with no increased risks observed for these defects.
These studies, as a group, showed no difference in the risk of birth defects among those infants whose mothers had taken Bendectin during the first trimester of pregnancy and those infants whose mothers had not. This underlying risk may be increased due to maternal age, medical or family history, or exposures to certain drugs, chemicals or levels of radiation known to cause birth defects.
Published data show that Bendectin use in pregnancy does not increase a woman's baseline risk of having a child with a major malformation. As a result of the discontinuation of Bendectin, which was the only approved drug for nausea and vomiting of pregnancy, hospital admissions for vomiting in pregnancy doubled during the five-year period which was the time period when Bendectin use declined and then ultimately ceased in the Unites States , birth-defect rates remain constant.
In an epidemiolgical assessment of the safety and efficacy of Bendectin, the author showed the time-trend of NVP, hospitalizations, limb reduction deformities and Bendectin usage In , the FDA determined that Bendectin was not withdrawn from the market for reasons of safety or effectiveness. The conference organizers were T. The goal was to identify gaps in knowledge about the mechanism of disease and opportunities for therapeutic intervention that may help women and their families cope with the problem of NVP.
In his presentation, Frank Miller, MD, from Lexington, KY and at the time President of ACOG, opened his presentation with the following comment: "One cannot practice obstetrics for any length of time and not be impressed that nausea and vomiting is a real disease. The combination doxylamine-pyridoxine is shown as the drug of choice for the treatment of Nausea and Vomiting of Pregnancy.
When Merrel Dow stopped the sales of Bendectin worldwide in , the Canadian generic version, Diclectin containing doxylamine and pyridoxine , remained on the market as the only approved treatment of nausea and vomiting of pregnancy.
Click here to view graph. The First International Conference on Nausea and Vomiting of Pregnancy held in Toronto, Ontario, called for increased attention to this medical condition and its potentially serious complications. The information provided on this www. Physician and clinician Gideon Koren, who founded Motherisk in , was a vocal proponent of the drug, while also a paid consultant to Duchesnay.
A study written with St. The St. Both studies received a smattering of media coverage, but no further action. So when Kardashian took to social media in July to shill for Diclegis, the same compound as Diclectin approved by the U. Have you heard about this? Nor was there mention of side effects such as serious drowsiness. An image of Kim Kardashian with a bottle of Diclegis that was posted to her Instagram account. I thought that if I signed the agreement, [then I] could see what was there.
I know this is an absurd situation. The confusion is compounded by ongoing questions about Motherisk research and former director Koren. Last year, as the result of a Toronto Star investigation, the unit came under fire for inaccuracies in its drug and alcohol hair-testing program, analysis routinely used in criminal and child welfare cases.
That divided opinion still surrounds a drug taken by millions of pregnant women is unacceptable, of course. The confusion can be traced to the blurring of lines between medical research and corporate funding, industry-researcher alliances and how institutional clout—and high-profile endorsement—shape medical and public opinion. Navindra Persaud poses at the St. Like many doctors, he prescribed the drug routinely for NVP, a condition that occurs in more than half of pregnancies.
Examining whether or not Diclectin actually works is a marked departure from the decades-long focus on its safety, resulting from a similar compound being the centrepiece of birth-defect lawsuits in the U. Avoid large meals. Stay hydrated, and drink plenty of liquids. Try eating foods that contain ginger, such as ginger tea or ginger ale.
Try taking your vitamins at night, since you might be able to sleep through any irritation they may cause. Talk to your doctor about possibly increasing vitamin B6 in your diet. Avoid poorly ventilated spaces and irritating smells. Do not smoke, and avoid areas where people are smoking. Talk to your doctor about trying acupressure wrist bands or acupuncture.
More Videos Dealing with morning sickness Story highlights A provocative new paper questions the efficacy of the morning sickness drug Diclegis Other experts and the company behind the drug stand by its safety and efficacy. Many moms-to-be are prescribed some type of treatment to ease their morning sickness , from vitamins to medications. Diclegis, also known as Diclectin in Canada, is the only Food and Drug Administration-approved prescription medicine for morning sickness, according to its website.
It's so popular that reality star Kim Kardashian posted a promotional Instagram photo about it in Now, a provocative new paper questions the efficacy of the drug. There were flaws in the s clinical trial that the FDA and the federal department Health Canada used to approve the drug, then known as Bendectin , according to the paper.
Read More. The pooled estimate of the relative risk of any malformation at birth in association with exposure to Bendectin in the first trimester was 0. Separate analyses were undertaken for cardiac defects, central nervous system defects, neural tube defects, limb reductions, oral clefts, and genital tract malformations.
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