About Careers Internship MedBlogs Contact us
Medindia LOGIN REGISTER
Advertisement

Pyridoxine-Doxylamine: Questioning the Efficacy of a Commonly Used Morning Sickness Drug

Font : A-A+

Highlights
  • Nausea during the first trimester of pregnancy is referred to morning sickness.
  • Pyridoxine-doxylamine drug is an antihistamine drug used for the treatment of morning sickness.
  • An unpublished research questions the efficacy of a commonly used pyridoxine-doxylamine drug for morning sickness.

Pyridoxine-Doxylamine: Questioning the Efficacy of a Commonly Used Morning Sickness Drug

The efficacy of the commonly used pyridoxine-doxylamine medication for nausea during pregnancy was questioned in an unpublished research carried out by the Merrell-National Laboratories in 1970.

The 40 year old research study is now published in the PLOS One journal.

Advertisement


The study was published by Dr. Nav Persaud, family physician, research scientist at St. Michael's Hospital, restoring invisible and abandoned trials (RIAT) initiative which has unpublished studies that are difficult to determine the treatment options.

Pyridoxine-doxylamine drug sold under the name Diclectin was tested for its efficacy to treat morning sickness in the first trimester of pregnancy.
Advertisement

Even though the results of the clinical trial was not published, regulatory bodies like Health Canada and the United States Food and Drug Administration (USFDA) has collected information to approve the drug.

Around 33 million women in the world are prescribed with pyridoxine-doxylamine drug.

According to the Society of Obstetricians and Gynecologists of Canada, the drug is considered to be a standard of care for women with nausea and vomiting "since it has the greatest evidence to support its efficacy and safety."

Dr. Persaud, said, even though there are many flaws in the study which call questioning on why the study was not published, He had collected about 36000 pages of documents from the FDA and Health Canada about the topic.

Clinical Trial
The clinical trial was conducted on 2308 pregnant women who were experiencing nausea and vomiting. The data was collected from 14 clinics in the United States. These women were divided into eight groups, out of which one received placebo and other seven groups received combination of drugs.

The research data was collected from 1600 participants and proportion of data collected from the seven groups who received combination of drugs were found to evaluate as moderate or excellent when compared to those who received placebo.

Dr. Persaud's Conclusions
  • No availability of the final study results.
  • Even though the trial lasted for a week, there was an increased number of participants who did not complete it.
  • Physicians did not score the symptoms clearly.
  • Data was unavailable for 37% of patients in the placebo group
  • Unable to contact the researchers since most of them had died
  • Data collected from 30patients were excluded due to an order of the Commissioner of Food and Drugs in a 1975 letter which stated" data recording in absence of patient visits".
Morning Sickness
Nausea that occurs during the first trimester of pregnancy is referred to as Morning Sickness.

Around 7 in 10 women experience morning sickness during pregnancy.

Morning sickness which sometimes requires hospitalization may be called Hyperemesis gravidarum.

Symptoms of Morning Sickness
  • Nausea
  • Vomiting
  • Anxiety and depression
  • Loss of appetite
Pyridoxine - Doxylamine Drug
Doxylamine is a sedative antihistaminic drug which is marketed along with pyridoxine for the treatment of morning sickness.

Side Effects of Pyridoxine-Doxylamine
  • Dry mouth
  • Drowsiness
  • Abdominal Upset
  • Vertigo


Source: Medindia

Citations   close

Please use one of the following formats to cite this article in your essay, paper or report:

  • APA

    Madhumathi Palaniappan. (2017, January 05). Pyridoxine-Doxylamine: Questioning the Efficacy of a Commonly Used Morning Sickness Drug. Medindia. Retrieved on Aug 07, 2022 from https://www.medindia.net/news/healthwatch/pyridoxine-doxylamine-questioning-the-efficacy-of-a-commonly-used-morning-sickness-drug-166749-1.htm.

  • MLA

    Madhumathi Palaniappan. "Pyridoxine-Doxylamine: Questioning the Efficacy of a Commonly Used Morning Sickness Drug". Medindia. Aug 07, 2022. <https://www.medindia.net/news/healthwatch/pyridoxine-doxylamine-questioning-the-efficacy-of-a-commonly-used-morning-sickness-drug-166749-1.htm>.

  • Chicago

    Madhumathi Palaniappan. "Pyridoxine-Doxylamine: Questioning the Efficacy of a Commonly Used Morning Sickness Drug". Medindia. https://www.medindia.net/news/healthwatch/pyridoxine-doxylamine-questioning-the-efficacy-of-a-commonly-used-morning-sickness-drug-166749-1.htm. (accessed Aug 07, 2022).

  • Harvard

    Madhumathi Palaniappan. 2021. Pyridoxine-Doxylamine: Questioning the Efficacy of a Commonly Used Morning Sickness Drug. Medindia, viewed Aug 07, 2022, https://www.medindia.net/news/healthwatch/pyridoxine-doxylamine-questioning-the-efficacy-of-a-commonly-used-morning-sickness-drug-166749-1.htm.

Advertisement

Advertisement
News A-Z
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
What's New on Medindia
Baldness can be Cured and Prevented: let us see How!
Drinking Beer or Wine Every Day Could Cause Age-related Diseases
Low-Calorie Diet for Diabetes
View all
Recommended Reading
News Archive
Date
Category
Advertisement
News Category

Medindia Newsletters Subscribe to our Free Newsletters!
Terms & Conditions and Privacy Policy.

More News on:
Drug Toxicity Signature Drug Toxicity Amyotrophic Lateral Sclerosis (ALS) Drugs Banned in India Morning Sickness 

Most Popular on Medindia

Selfie Addiction Calculator Color Blindness Calculator Find a Doctor Accident and Trauma Care The Essence of Yoga Turmeric Powder - Health Benefits, Uses & Side Effects Drug - Food Interactions Blood Pressure Calculator How to Reduce School Bag Weight - Simple Tips Pregnancy Confirmation Calculator
This site uses cookies to deliver our services. By using our site, you acknowledge that you have read and understand our Cookie Policy, Privacy Policy, and our Terms of Use