Navigation Links
FDA: Risk of Oral Birth Defects in Children Born to Mothers Taking Topiramate
Date:3/4/2011

SILVER SPRING, Md., March 4, 2011 /PRNewswire-USNewswire/ -- New data suggest that the drug Topamax (topiramate) and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy, the U.S. Food and Drug Administration said today.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

Before prescribing topiramate, approved to treat certain types of seizures in people who have epilepsy, health care professionals should warn patients of childbearing age about the potential hazard to the fetus if a woman becomes pregnant while using the drug. Topiramate also is approved to prevent migraine headaches, but not to relieve the pain of migraines.  

"Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "Alternative medications that have a lower risk of birth defects should be considered."

Cleft lip and cleft palate, collectively called oral clefts, are birth defects that occur when parts of the lip or palate do not completely fuse together early in the first trimester of pregnancy, a time when many women do not know they are pregnant. The defects range from a small notch in the lip to a groove that runs into the roof of the mouth and nose, possibly leading to problems with eating, talking, and to ear infections. Surgery often is performed to close the lip and palate and most children do well after treatment.

Data from the North American Antiepileptic Drug (AED) Pregnancy Registry indicate an increased risk of oral clefts in infants exposed to topiramate during the first trimester of pregnancy. Infants exposed to topiramate as a single therapy experienced a 1.4 percen
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Progesterone Therapy and Preterm Birth: More Evidence Helps Identify Women Who Can Benefit
2. Male Birth Control Pill, Blackberry Extract for Gingivitis, Skin Cancer and Digestive Health Top List of New Medical Discoveries
3. Huge Drop in Preterm Birth-Risk Among Women Taking Folic Acid One Year Before Conception
4. Molecular Therapy Succeeds in Preventing Craniofacial Birth Defect in Mice
5. National Study Shows Magnesium Sulfate Reduces Risk of Cerebral Palsy in Premature Births
6. Infant Blood May Provide Insights into Diseases Present at Birth
7. Preterm Births Rise 36 Percent Since Early 1980s
8. New Study Proves Multiple Births From IVF Can Be Avoided
9. Taking Folic Acid for a Year Before Pregnancy May Reduce Risk of Preterm Birth
10. Diabetes Gene Raises Odds of Lower Birth Weight
11. Study Links Fetal Fibronectin Testing with Changes in Management Decisions for Symptomatic and Asymptomatic Women at Risk for Preterm Birth
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/22/2014)... , Sept. 22, 2014  Neuralstem, Inc. (NYSE MKT: CUR) ... investigator at Emory University, presented long-term follow up data ... stem cells in the treatment of amyotrophic lateral sclerosis ... which occurred at the Annual Symposium on ALS of ... , on Friday, and was not open to the ...
(Date:9/22/2014)... Pa. , Sept. 22, 2014  Olympus, ... innovative solutions for medical and surgical procedures, among ... a deal with Munich -based ... Kick ® Navigation. This agreement applies to ... for cross-disciplinary U.S. sales and all distribution outside ...
(Date:9/22/2014)... MEETING, Pa. , Sept. 22, 2014 /PRNewswire/ ... announced today it has initiated a phase I ... trial will evaluate the safety, tolerability, and immunogenicity ... 6 (HPV-6), which causes most aerodigestive cancers. ... nose, throat, vocal cords, and parts of the ...
Breaking Medicine Technology:Neuralstem ALS Investigator Presents Long-Term Follow Up Phase I Data 2Neuralstem ALS Investigator Presents Long-Term Follow Up Phase I Data 3Neuralstem ALS Investigator Presents Long-Term Follow Up Phase I Data 4Olympus Partners with Brainlab as Exclusive Distributor for ENT Products in U.S. Market 2Olympus Partners with Brainlab as Exclusive Distributor for ENT Products in U.S. Market 3Olympus Partners with Brainlab as Exclusive Distributor for ENT Products in U.S. Market 4Inovio Pharmaceuticals Expands HPV Immunotherapy Development to Aerodigestive Cancers 2Inovio Pharmaceuticals Expands HPV Immunotherapy Development to Aerodigestive Cancers 3Inovio Pharmaceuticals Expands HPV Immunotherapy Development to Aerodigestive Cancers 4
... Mylan Inc. (Nasdaq: MYL ) today announced ... from the U.S. Food and Drug Administration (FDA) for its ... 8.5 mg, 17 mg, 25.5 mg and 34 mg. Mylan ... ANDA containing a Paragraph IV certification for Nisoldipine ER Tablets ...
... Inc. (Amex: AEN ), a developer of innovative ... it has executed an agreement for the sale of approximately ... share to two new institutional investors in a registered direct ... also receive warrants to purchase approximately 1.42 million shares of ...
Cached Medicine Technology:Adeona to Raise $4 Million in Registered Direct Offering 2Adeona to Raise $4 Million in Registered Direct Offering 3
(Date:9/23/2014)... 23, 2014 WetKeys Washable Keyboards announces ... in their industrial keyboards line. Labeled ... to last longer in heavy-duty industrial computing for the ... where grease and oil can destroy usability or cause ... constant threat to the longevity of computer equipment and ...
(Date:9/23/2014)... September 23, 2014 Névo takes a ... precision timepiece and adding advanced activity tracking and phone ... monitors steps, distance, calories burned, and more. , ... to adopt healthy habits in their busy lives to ... small changes that produce healthy results, but until now, ...
(Date:9/23/2014)... (PRWEB) September 23, 2014 Many people have ... Everyone has seen nightclub or television acts in which a ... members and then uses the power of suggestion to have ... have also heard about hypnosis as an aid in managing ... only a fraction of the ways hypnotism can be used. ...
(Date:9/23/2014)... Texas (PRWEB) September 23, 2014 Medicine in ... its central Austin location at 711 W. 38th, Suite G4. ... at their north Austin location, increased demand for MIM’s superior ... “My team and I are extremely excited about bringing our ... Martha Pyron, owner of Medicine in Motion. “We’ll continue to ...
(Date:9/23/2014)... Recently, BuyTopDress.com, a popular supplier of wedding dresses and special ... fashionable marine ball dresses . Along with this, the ... brand new items; all of them are now provided with ... now, BuyTopDress.com has won more than 2000 happy customers in ... its products and after-sale services. The company is offering thousands ...
Breaking Medicine News(10 mins):Health News:WetKeys Announces New Oil Resistant Keyboard for Industrial Computing, Food Processing Plants, Automotive Factories and Machine Shops 2Health News:WetKeys Announces New Oil Resistant Keyboard for Industrial Computing, Food Processing Plants, Automotive Factories and Machine Shops 3Health News:WetKeys Announces New Oil Resistant Keyboard for Industrial Computing, Food Processing Plants, Automotive Factories and Machine Shops 4Health News:WetKeys Announces New Oil Resistant Keyboard for Industrial Computing, Food Processing Plants, Automotive Factories and Machine Shops 5Health News:Nevo changes the face of fitness wearables with an analogue watch combining activity tracking, phone notifications, and LED goal progress indicators for active lifestyles 2Health News:Nevo changes the face of fitness wearables with an analogue watch combining activity tracking, phone notifications, and LED goal progress indicators for active lifestyles 3Health News:Hypnosis: What You Don't Know, Dr. Richard Dauber with Morris Psychological Group Dispels Myths and Offers Tips about a Valuable Therapeutic Approach 2Health News:Hypnosis: What You Don't Know, Dr. Richard Dauber with Morris Psychological Group Dispels Myths and Offers Tips about a Valuable Therapeutic Approach 3Health News:Hypnosis: What You Don't Know, Dr. Richard Dauber with Morris Psychological Group Dispels Myths and Offers Tips about a Valuable Therapeutic Approach 4Health News:Austin Sports Medicine Practice to Host Grand Opening Event for Second Location 2Health News:Fashionable Marine Ball Dresses Added To BuyTopDress.com’s Collection 2
... detected with self-illuminating polymers. The originators, at Linkping University ... can also render the prions harmless, and potentially cure ... at the University Hospital in Zrich tested the luminescent ... brains of mice that had been infected with prions. ...
... controlled by lightning-quick electrical impulses in the brain, the ... in the membranes of the cells can cause things ... Linkping University has now published new discoveries that can ... key molecules behind the electrical impulses are voltage-activated ion ...
... cellular protein called HDAC6, newly characterized as a gatekeeper ... novel target for treating and preventing stress-linked disorders, such ... research from the Perelman School of Medicine at the ... secreted by the body during stress. A small amount ...
... (HealthDay News) -- The shingles vaccine is generally safe and ... Shingles, which affects more than 1 million people each year ... by the dormant chickenpox virus, which can reactivate and replicate, ... risk because immunity against the virus that causes shingles declines ...
... Canada demonstrated the unequivocal effectiveness of brain surgeries for ... not been widely adoptedin fact, it is dramatically underutilized ... California, San Francisco (UCSF). The study, published this ... the number of Americans having the surgery has not ...
... , MONDAY, April 23 (HealthDay News) -- It goes without ... dangerous, but they can also be very expensive, an expert ... uncommon for a person bitten by a venomous snake, said ... A&M University in College Station. The total cost includes ...
Cached Medicine News:Health News:Prions in the brain eliminated by homing molecules 2Health News:Molecule movements that make us think 2Health News:Gatekeeper of brain steroid signals boosts emotional resilience to stress 2Health News:Gatekeeper of brain steroid signals boosts emotional resilience to stress 3Health News:Shingles Vaccine Safe, Underutilized, Study Says 2Health News:Brain surgery for epilepsy underutilized 2Health News:Brain surgery for epilepsy underutilized 3Health News:Cost of Snakebite Therapy May Squeeze Victims' Wallets 2
... Codman Sofwire Cable ... bony fixation including sublaminar ... maxillo facial surgery, sternotomy ... cables and a complete ...
Demineralized bone matrix dispensed in a jar. Fibers will be free of foreign matter. Glycerol 70-88% by weight. Calcium content less than 8%....
... Inductive demineralized bone matrix and ... cancellous chips will be free ... matrix particle size is 125 ... particle size is 1 - ...
... new generation Endoalpha is a centralized O.R. ... and the nurse by giving them better ... provides protection against obsolescence, as future enhancements ... the purchase of an entirely new system. ...
Medicine Products: