HOME >> BIOLOGY >> NEWS
First analysis of FDA's mifepristone adverse event reports

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 200
'"/>

Contact: Stan Lloyd, PharmD
assisted@hwbooks.com
513-793-3555
Annals of Pharmacotherapy
28-Dec-2005


Page: 1 2

Related biology news :

1. First case of successful ovarian tissue transplantation between two, nonidentical sisters
2. First new multiple sclerosis gene found in 30 years
3. First genome-wide study of infectious disease opens new avenues for HIV treatment, vaccines
4. First all-African produced genetically engineered maize is resistant to maize streak virus
5. First baby is born after oocytes were matured in the lab and frozen
6. First confirmed common genetic risk factors for breast cancer
7. First demonstration of new hair follicle generation in an animal model
8. First research to show that diabetes damages DNA in mens sperm and may affect fertility
9. First demonstration of muscle restoration in an animal model of Duchenne muscular dystrophy
10. First systematic study of Chinas one-child policy reveals complexity, effectiveness
11. First international conference on self-healing materials

Post Your Comments:
*Name:
*Comment:
*Email:


(Date:7/18/2020)... (PRWEB) , ... July 17, 2020 , ... Commercial launch ... on pharma’s ability to discover a COVID cure or vaccine, the global economic downturn ... and price pressure is not going away and capturing full value from every product ...
(Date:7/2/2020)... ... July 01, 2020 , ... AltruBio Inc. http://www.altrubio.com ... a biologic for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGVHD), at European ... J Martin of the Fred Hutchinson Cancer Research Center, this single-arm, open-label Phase ...
(Date:6/28/2020)... ... June 25, 2020 , ... ... solutions for biopharmaceutical R&D, today announced that it has entered into a ... multispecific antibodies (Multiclonics®), to support their translational and clinical research strategy to ...
Breaking Biology News(10 mins):
(Date:7/31/2020)... Mass. and SOMERSET, N.J (PRWEB) , ... July ... ... leading genome editing company, and Catalent, the leading global provider of advanced delivery ... consumer health products, today announced that they have entered into a strategic partnership ...
(Date:7/22/2020)... ... , ... Join experts from Reed Tech , Gary Saner, Sr. Manager, ... hour live webinar on Thursday, August 13, 2020 at 11am EDT (4pm ... devices. Specifically, for medical devices, the NMPA has departments dealing with medical device registration ...
(Date:7/18/2020)... ... , ... dicentra , a leading Contract Research Organization ... pleased to announce that Charles Galea has joined its clinical trials division as ... accomplished and results-driven sales executive with over 10 years of expertise in business ...
(Date:7/10/2020)... ... July 09, 2020 , ... Sentien Biotechnologies, Inc., a clinical-stage ... Allen R. Nissenson, M.D., F.A.C.P., as its Chief Medical Officer. Dr. Nissenson ... product, SBI-101. Dr. Nissenson serves as an Emeritus Professor of Medicine at ...
Breaking Biology Technology:
Cached News: