Navigation Links
Topiramate Exposure and Birth Defect Data to be Presented at the 29th International Epilepsy Congress
Date:7/20/2011

was 0.85 (0.18-4.07) for OCs and the relative risk was 0.87 (0.59-1.28) for MCMs. There were no statistically significant differences in OC or MCM frequency between the topiramate and control groups.

"The results of this retrospective study show that in comparison to the other non-teratogenic AED group or non-topiramate exposed epileptic group, topiramate exposure during pregnancy does not appear to significantly increase the risk of oral clefts or major congenital malformations," commented Peter Tam, president of VIVUS, Inc.  "It is important to point out that this is not the ongoing, larger FORTRESS study, which utilizes medical claims databases from different sources than Wolters Kluwer.  This retrospective observational study was conducted to provide us with an early assessment of the teratogenic potential of topiramate.  The FORTRESS results, expected in the fourth quarter of 2011, along with the results from this study, will be used as part of the QNEXA NDA resubmission to the FDA.  To our knowledge, the Wolters Kluwer's study represents the largest retrospective cohort study conducted to date for topiramate and adds to the growing body of information on the teratogenic potential of topiramate as well as other antiepileptic agents."

The study, funded by VIVUS, was conducted by Wolters Kluwer utilizing datasets from the United States and followed patients' Pharmacy and Medical Claims (January 2003 - December 2010) and covered an estimated 177 million lives. Probable exposure during pregnancy was refined using data on script fill date, days of medication supplied, infant birth date, and ICD-9 codes for birth term.

Details of the presentation:

Date: August 31, 2011

Location: Marriott Park Hotel Rome, Italy
Title: Retrospective analysis of major congenital malformations (MCMs) and oral clefts (OC) associated with in utero topiramate (909)
Authors: Pack A(1), Meador K(2), Bhattacharyya
'/>"/>

SOURCE VIVUS, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Spherics, Inc. Announces Reduced Cognitive Impairment of Novel Extended Release Topiramate (SRx-502) as Compared to Topamax(R)
2. Upsher-Smith Laboratories Announces Initiation of Phase III Clinical Trial of USL255 (Extended-Release Topiramate) for Adjunctive Treatment of Partial-Onset Epilepsy
3. Upsher-Smith Laboratories Announces Initiation of Open-Label Extension Study of USL255 (Extended-Release Topiramate) for Adjunctive Treatment of Partial-Onset Epilepsy
4. Data Suggests Positive Pharmacokinetic Results From Phase I Research of Extended-Release Topiramate
5. FDA: Risk of Oral Birth Defects in Children Born to Mothers Taking Topiramate
6. Phase I Research of Extended-Release Topiramate Shows Less Fluctuation in Plasma Levels
7. Vaccine Study in New England Journal of Medicine Wrong in Concluding Mercury Exposures are Harmless, States SafeMinds
8. Dynavax Begins TOLAMBA(TM) Environmental Exposure Chamber Study
9. HIV Prevention Expert Dr. Timothy Mastro Speaks on Future of Pre-Exposure Prophylaxis at International AIDS Conference
10. New AVAC Report on Pre-Exposure Prophylaxis Calls for Immediate Planning to Anticipate Study Results of Potential New HIV Prevention Option
11. Two New Clinical Studies Show That Limited Exposure to Blood Transfusion Significantly Increases Morbidity and Mortality After Surgery
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/17/2015)... WASHINGTON , April 17, 2015 ... (PhRMA) honored 13 employees from 12 biopharmaceutical companies ... extraordinary efforts in policy advocacy and community service. ... for Health Champion Awards were created by the ... only excelled in their careers, but have also ...
(Date:4/17/2015)... , Apr. 16, 2015 Research and Markets ... addition of the "The Corporate Reputation of ... Global Edition " report to their offering. ... Patient Perspective, is now in its fourth edition. ... published early 2015). For each annual Corporate Reputation ...
(Date:4/17/2015)... -- Bionomics Limited (ASX:BNO, ADR:BMICY), a biopharmaceutical company focused ... the treatment of cancer and diseases of the central ... three of its most advanced oncology programs at the ... Annual Meeting being held from April 18-22, 2015 ... The presentation on the BNC105 program describes ...
Breaking Medicine Technology:PhRMA Applauds 2015 We Work For Health Champion Award Winners 2PhRMA Applauds 2015 We Work For Health Champion Award Winners 3The Corporate Reputation of Pharma - The Global Patient Perspective in 2014 2Bionomics Showcases Oncology Drug Development Programs at 2015 AACR Annual Meeting 2Bionomics Showcases Oncology Drug Development Programs at 2015 AACR Annual Meeting 3Bionomics Showcases Oncology Drug Development Programs at 2015 AACR Annual Meeting 4Bionomics Showcases Oncology Drug Development Programs at 2015 AACR Annual Meeting 5
... HONG KONG, Jan. 5, 2011 SuperNova Diagnostics®, Inc., ... health applications, announced today that Neil J. Campbell, president ... conjunction with the J.P. Morgan Healthcare Conference in San ... be given at the Parc 55 Wyndham Hotel on ...
... Jan. 5, 2011 / PRNewswire / -- Nektar ... Officer, Howard W. Robin, is scheduled to present at the ... at the Westin St. Francis Hotel on Tuesday, January 11, ... will be accessible via a Webcast through a link posted ...
Cached Medicine Technology:SuperNova Diagnostics® to Present at Biotech Showcase™ 2011 During J.P. Morgan Healthcare Conference January 10-13 2Nektar Therapeutics' President and CEO, Howard W. Robin, to Present at the 29th Annual J.P. Morgan Healthcare Conference in San Francisco, CA 2
(Date:4/18/2015)... (PRWEB) April 18, 2015 More than ... sale now at TheCelebrityDresses.com, the #1 online store carrying ... ongoing many girls have got their perfect dresses for ... the celebrity fashion prom dresses at TheCelebrityDresses.com would be ... designed more than 2000 prom dresses inspired by the ...
(Date:4/18/2015)... Aureus Medical Group (web: aureusmedical.com), ... therapy jobs, has announced that it will participate ... Therapy Association Annual Conference to be held May ... SC. , The SCAPTA Annual Conference offers ... and services. , Representatives from Aureus Medical’s ...
(Date:4/18/2015)... FL (PRWEB) April 18, 2015 PHOENIX, ... Hillsborough County, along with 11 other secure destruction professionals ... Secure Destruction Specialists (CSDS). He will now display “CSDS” ... exams were offered before the National Association of Information ... Illinois and another Grapevine, Texas. Of the 20 people ...
(Date:4/17/2015)... (PRWEB) April 18, 2015 Heritage Woods ... begin its Supportive Living Week Celebration on April 20 ... having a healthy mind, body and soul. , The ... McLeansboro, Illinois, serves older adults of all incomes, including ... their independence. , Supportive Living Week is observed every ...
(Date:4/17/2015)... Rosetta Radiology is proud to now offer ... of diagnostic imaging services. This solidifies them as a ... East Side of Manhattan. , The new imaging equipment ... of PET-CT, combined with Rosetta’s state of the art ... with patients through several stages of the cancer care ...
Breaking Medicine News(10 mins):Health News:Prom Dresses 2015 on Sale at TheCelebrityDresses.com 2Health News:Healthcare Staffing Leader, Aureus Medical Group, to Exhibit at the South Carolina Physical Therapy Association Annual Conference 2Health News:Heritage Woods of McLeansboro Affordable Assisted Living to Celebrate Supportive Living Week 2Health News:Heritage Woods of McLeansboro Affordable Assisted Living to Celebrate Supportive Living Week 3
... Education Event Hosted to Promote Importance of Prevention and Early ... Men,s Health Network has partnered with Pfizer Helpful Answers, the ... Nursing and the Louisiana Association of Nurse Practitioners to offer ... Legislature members and staff. , , In a ...
... Honored and Local Youth Learn About Teamwork During the Games , ... in college softball will soon take the field in Oklahoma City. The ... 1 through June 3 at ASA Hall of Fame Stadium, and AT&T* ... Society and The Oklahoma City Boys & Girls Club. , , ...
... a subsidiary of Aon Corporation (NYSE: ... NSO Marketplace(SM) to offer a broader array of products ... personal needs of the nursing community. For more than 30 years, NSO ... insurance to over 675,000 nurses in the United States. , ...
... PHILADELPHIA, June 1 Researchers studying a difficult-to-treat form ... line of mice that experiences seizures with features closely ... genetically engineered mice provide a new opportunity for scientists ... , "Approximately one out of every 100 infants ...
... a Photo Contest to Celebrate National Dairy & Smile Month , ... parent and child starts at sundown. Bath: Check. Pajamas ... Sigh. Suddenly, the nightly routine can come to a ... According to a 2006 report by the Dental Health Foundation, by ...
... Growing Demographic of Older Adults , , NEW YORK, ... pre-eminent organizations focused on aging and self-esteem, today launched a ... based in Geneva, Switzerland, and New York, will utilize its ... with the latest techniques in enjoying life in "coming of ...
Cached Medicine News:Health News:Bringing Uninsured and Underinsured Issues Into the Spotlight in the Louisiana State Legislature 2Health News:Bringing Uninsured and Underinsured Issues Into the Spotlight in the Louisiana State Legislature 3Health News:AT&T Shares 2009 NCAA Women's College World Series With American Cancer Society and Boys & Girls Club 2Health News:Exclusive Marketplace for Nursing Professionals Launched by Nurses Service Organization 2Health News:Exclusive Marketplace for Nursing Professionals Launched by Nurses Service Organization 3Health News:Findings in Epilepsy Gene in Animals May Guide Treatment Directions for Infants 2Health News:Findings in Epilepsy Gene in Animals May Guide Treatment Directions for Infants 3Health News:Findings in Epilepsy Gene in Animals May Guide Treatment Directions for Infants 4Health News:Say Cheese With Milk 2Health News:Say Cheese With Milk 3Health News:Say Cheese With Milk 4Health News:AgeEsteem(R) Launches New Web Site, Blog, and 'How To' Book 2Health News:AgeEsteem(R) Launches New Web Site, Blog, and 'How To' Book 3
... MLA 750 is an ideal backup ... Photometric end point detection means there ... no electrodes are inserted into the ... impossible. The MLA 750 operates with ...
... Advance can reduce costs and ... With its superior ACL technology, ... to use coagulation analyzer that ... the protective transparent cover increases ...
HemoSite meter can be used to measure the effects of transfusion or the treatment of deficiency states. It is fast, easy, convenient and discrete....
... StatSite MHgb test system ... battery-operated, dedicated hemoglobin test system ... offices, public health clinics, blood ... truly portable system is designed ...
Medicine Products: