Featured Research

from universities, journals, and other organizations

First Analysis Of FDA's Mifepristone Adverse Event Reports

Date:
December 28, 2005
Source:
Annals of Pharmacotherapy
Summary:
The abortion drug mifepristone (Mifeprex,TM RU-486), initially touted as a more convenient alternative to surgical abortion, has been linked to serious adverse reactions, including several deaths in otherwise healthy women. In "Analysis of Severe Adverse Events Related to the Use of Mifepristone as an Abortifacient" published in The Annals of Pharmacotherapy, researchers provide an in-depth study of the mifepristone adverse event data gathered through the FDA's Adverse Event Reporting System.

The abortion drug mifepristone (Mifeprex,TM RU-486), initially touted as a more convenient alternative to surgical abortion, has been linked to serious adverse reactions, including several deaths in otherwise healthy women. In "Analysis of Severe Adverse Events Related to the Use of Mifepristone as an Abortifacient," researchers Margaret M Gary MD and Donna J Harrison MD provide an in-depth study of mifepristone adverse event data gathered through the FDA's Adverse Event Reporting System. Their research is available now at The Annals of Pharmacotherapy Online (www.theannals.com) and will appear in the journal's February issue.

This first published analysis of the FDA's mifepristone reports describes 607 adverse events reported over a 4-year period, including fatalities resulting from bleeding or septic shock. Also reviewed are numerous reports of severe bleeding, infection, unsuccessful termination of pregnancy, and fetal malformations that appeared after failed abortion attempts. Reports also detail ruptured ectopic pregnancies, a potentially fatal condition requiring emergency surgical intervention. Unusual allergic reactions were also noted, which Gary and Harrison suspect may have resulted directly from the drug's mechanism of action.

Prompted by their findings, the authors call for increased research into the allergic and fatal septic reactions associated with mifepristone. They also urge that ultrasound imaging be performed before use of the drug to rule out ectopic pregnancies and propose that a fetal registry be established to track birth defects in mifepristone survivors. Finally, incomplete information in many of the adverse event reports prompts Gary and Harrison to speculate on whether the FDA's Adverse Event Reporting System adequately identifies risks and protects public health.

At least 5 women in the US and Canada are known to have died from septic shock after taking mifepristone. In 2004, the labeling of mifepristone was amended to include a black box warning about bacterial infections, sepsis, and death that may occur after use. A citizen petition for withdrawal of mifepristone from the US market has been submitted to the FDA. The petition cites numerous safety concerns and FDA procedural violations that occurred during the drug's approval.

###

The Annals of Pharmacotherapy is a leading peer-reviewed, international pharmacotherapy journal for physicians, pharmacists, and other healthcare professionals. Published by Harvey Whitney Books Company, for 40 years The Annals has featured articles directly related to the safe, effective, and economical use of medications and related devices in patient care. The journal's editorial office is headquartered at 8044 Montgomery Road, Suite 415, Cincinnati, Ohio 45236-2919, USA. The journal is available in print and online in full text at www.theannals.com.


Story Source:

The above story is based on materials provided by Annals of Pharmacotherapy. Note: Materials may be edited for content and length.


Cite This Page:

Annals of Pharmacotherapy. "First Analysis Of FDA's Mifepristone Adverse Event Reports." ScienceDaily. ScienceDaily, 28 December 2005. <www.sciencedaily.com/releases/2005/12/051228103007.htm>.
Annals of Pharmacotherapy. (2005, December 28). First Analysis Of FDA's Mifepristone Adverse Event Reports. ScienceDaily. Retrieved October 1, 2014 from www.sciencedaily.com/releases/2005/12/051228103007.htm
Annals of Pharmacotherapy. "First Analysis Of FDA's Mifepristone Adverse Event Reports." ScienceDaily. www.sciencedaily.com/releases/2005/12/051228103007.htm (accessed October 1, 2014).

Share This



More Health & Medicine News

Wednesday, October 1, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Pregnancy Spacing Could Have Big Impact On Autism Risks

Pregnancy Spacing Could Have Big Impact On Autism Risks

Newsy (Oct. 1, 2014) — A new study says children born less than one year and more than five years after a sibling can have an increased risk for autism. Video provided by Newsy
Powered by NewsLook.com
Robotic Hair Restoration

Robotic Hair Restoration

Ivanhoe (Oct. 1, 2014) — A new robotic procedure is changing the way we transplant hair. The ARTAS robot leaves no linear scarring and provides more natural results. Video provided by Ivanhoe
Powered by NewsLook.com
Insertable Cardiac Monitor

Insertable Cardiac Monitor

Ivanhoe (Oct. 1, 2014) — A heart monitor the size of a paperclip that can save your life. The “Reveal Linq” allows a doctor to monitor patients with A-Fib on a continuous basis for up to 3 years! Video provided by Ivanhoe
Powered by NewsLook.com
Attacking Superbugs

Attacking Superbugs

Ivanhoe (Oct. 1, 2014) — Two weapons hospitals can use to attack superbugs. Scientists in Ireland created a new gel resistant to superbugs, and a robot that can disinfect a room in minutes. Video provided by Ivanhoe
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
 
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:  

Breaking News:

Strange & Offbeat Stories

 

Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:  

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile iPhone Android Web
Follow Facebook Twitter Google+
Subscribe RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins