Navigation Links
Off-label morning sickness drug deemed safe for fetuses -- Ben-Gurion U. researchers

BEER-SHEVA, ISRAEL, June 10, 2009 Metoclopramide, a drug approved in the U.S. for nausea, vomiting and heartburn poses no significant risks for the fetus according to a large cohort study published in the June 11 issue of the prestigious New England Journal of Medicine, "The Safety of Metoclopramide Use in the First Trimester of Pregnancy" (N Engl J Med 2009;360:24 June 11, 2009).

According to the pediatrician and clinical pharmacologist, principal investigator Dr. Rafael Gorodischer, prof. emeritus at Ben-Gurion University of the Negev, "Metoclopramide is the drug of choice in Europe and Israel for "morning sickness-like" symptoms of nausea and vomiting, which are common in pregnant women. In the U.S. however, it is only used in the most severe cases, as it is an "off-label" use for nausea and vomiting during pregnancy. The findings of this very large cohort study examining infants born to mothers who were exposed to metoclopramide during the first trimester provide significant reassurance for the safety of the fetus when the drug is given to women to relieve nausea and vomiting during pregnancy."

Between 50 percent to 80 percent of pregnant women experience nausea and vomiting during the first trimester and beyond, which can be severe.

This study is collaboration between Ben-Gurion University of the Negev, Soroka University Medical Center and Clalit Health Services -- all in Beer-Sheva, Israel -- along with the Division of Pharmacology, Hospital for Sick Children in Toronto, Canada. The study is part of the doctoral thesis of Ilan Matok and was conducted by the three Israeli entities as part of the BeMORE collaboration (Ben-Gurion MotheRisk Obstetric Registry of Exposure). The study of the safety of other medications commonly used off-label in pregnancy is an ongoing project of BeMORE investigators in large cohorts of women in Southern Israel.

According to principal investigator epidemiologist Dr. Amalia Levy of the BGU Faculty of Health Sciences, and chairwoman of the BeMORE collaboration, "of the vast majority of medications approved for use, there is insufficient data from human studies to determine whether the benefits of therapy exceed the risk to the fetus. Medicines are approved for use only after there is sufficient scientific evidence demonstrating the drug safety and effectiveness for its intended uses. There is extensive experience with the use of this medication in non-pregnant persons, with evidence of overall low rates of adverse effects when it is used as recommended."

The safety of metoclopramide use during the first trimester of pregnancy was investigated by linking a database of medications dispensed over 10 years to all women registered in Clalit Health Services in the Sothern District of Israel, with databases containing maternal and infant hospital records of Soroka University Medical Center, during the same period. In the study, 3,458 (or 4.2 percent) were exposed to metoclopramide during the first trimester of pregnancy of the 81,703 infants born to mothers during the study period.

The rate of major congenital malformations identified in the group that was exposed to metoclopramide during the first trimester was 5.3 percent% (182 of 3458 infants), as compared with a rate of 4.9 percent (3834 of 78,245 infants).

As a result, exposure to metoclopramide among this group was not associated with significantly increased risks of major congenital malformations. The results were unchanged when therapeutic abortions of exposed fetuses were included in the analysis. In addition, infants exposed in utero had no increased risk of perinatal mortality, low birth weight or premature birth.

Data of this study support the labeling of metoclopramide for nausea and vomiting during pregnancy.


Contact: Andrew Lavin
American Associates, Ben-Gurion University of the Negev

Related medicine news :

1. IROs Help Decide Medically on Approved Uses of Off-Label Drugs for Cancer
2. Eli Lilly Pays a Record $1.4 Billion to Settle Federal and State Fraud Investigations into Illegal Zyprexa Off-Label Marketing Practices
3. Eli Lilly and Company Agrees to Pay $1.415 Billion to Resolve Allegations of Off-Label Promotion of Zyprexa
4. Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. Sued for Product Liability and Promoting the Off-Label Use of Infuse(R) Bone Graft Product, According to Page Perry, LLC
5. Medtronic, Inc. and Medtronic Sofamor Danek, USA, Inc. Sued for Product Liability and Promoting the Off-Label Use of Infuse(R) Bone Graft Product, According to Page Perry, LLC
6. Study Calls for Greater Scrutiny of Off-Label Drug Use
7. Most Off-Label Cancer Drug Use for Palliative Care
8. Biopharmaceutical Company, Cephalon, To Pay $425 Million & Enter Plea to Resolve Allegations of Off-Label Marketing
9. Abortion drugs off-label use may have led to deaths
10. Off-Label Drug Use Needs Strong Oversight
11. Otsuka to Pay More Than $4 Million to Resolve Off-Label Marketing Allegations Involving Abilify
Post Your Comments:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... ... locations throughout Arkansas that offers insurance and financial preparation services, is providing an ... Rock City Rescue organization. , Rock City Rescue is a locally recognized nonprofit ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... certification process to promote standards of excellence for the field of eating disorders, ... March 22 – 25, 2018 in Orlando, Florida at the Omni Resort at ...
(Date:10/13/2017)... ... 13, 2017 , ... Apple Rehab Shelton Lakes , which specializes in ... the facility as part of a disaster drill on October 3rd. , Apple Rehab ... City Emergency Manager, as well as the Connecticut Long Term Care Mutual Aid ...
(Date:10/13/2017)... Milford, NJ (PRWEB) , ... October 13, 2017 , ... ... weekend at scenic Alexandria Park in Milford, NJ. This free event, sponsored by ... and physical activity. The fun run is geared towards children of all ages; ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
Breaking Medicine News(10 mins):
(Date:10/11/2017)... FRISCO, Texas , Oct. 11, 2017 /PRNewswire/ ... healthcare services, has amplified its effort during National ... patients about hereditary cancer risks. ... Journal of Clinical Oncology calculated that more than ... to have inherited mutations in BRCA1 or BRCA2 and ...
(Date:10/5/2017)... , Oct. 5, 2017  In response ... of Oral and Maxillofacial Surgeons (AAOMS) released prescribing ... – to be used as a first-line therapy ... Recognizing the ... AAOMS White Paper "Opioid Prescribing: Acute and Postoperative ...
(Date:10/2/2017)...  Eli Lilly and Company (NYSE: LLY ... quarter of 2017 on Tuesday, October 24, 2017. Lilly ... with the investment community and media to further detail ... will begin at 9 a.m. Eastern time. Investors, media ... of the conference call through a link that will ...
Breaking Medicine Technology: