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Areas > Dangerous Drugs > Paxil Paxil® Linked to Birth Defects
On September 27, 2005, the Food and Drug Administration (FDA) and GlaxoSmithKline notified healthcare professionals of changes to the Pregnancy/PRECAUTIONS section of the Prescribing Information for Paxil® to describe the results of a study of major congenital malformations, which are physical body or organ malformations existing at birth.
The study suggested women taking Paxil are at an increased risk of their children being born with major birth defects as compared to other antidepressants (1). GlaxoSmithKlines study of more than 3,500 pregnant women revealed that those who took Paxil were twice as likely to bear children with major birth defects vs. other antidepressant drugs (2). The most common defects were cardiovascular and occurred about 50% more than in the general population.
In December 2005, the FDA advised healthcare professionals of early study results, which suggested that Paxil increases the risk for birth defects--particularly heart defects--when women take it during the first three months of pregnancy (3).
Paxil is a drug approved by the FDA to treat depression, generalized anxiety disorder (GAD), social anxiety disorder, panic disorder, obsessive compulsive disorder (OCD), and posttraumatic stress disorder (PTSD) (4). Paxil is a selective serotonin reuptake inhibitor (SSRI) drug, which has been linked to a higher risk of suicide rates in adults taking the drug (5). On September 14, 2004, the FDA voted 15-8 to recommend SSRI drug manufacturers add a black box warning label stating that these drugs can be linked to suicidal thoughts and behavior in children and adolescents. The black box warning is the most strongly worded and serious label available. All magazine and television ads are required to include the warning.
Additionally, in February 2005, Spanish researchers reported that babies born to women who were taking SSRIs may experience neonatal withdrawal syndrome within the first few days of birth, and this association was highest in mothers who were taking Paxil (6).
The FDA issued the following statement: Healthcare professionals are advised to carefully weigh the potential risks and benefits of using paroxetine [Paxil] therapy in women during pregnancy and to discuss these findings as well as treatment alternatives with their patients (1).
If you or someone you care about has suffered the anguish of a child born with birth defects after taking prescription drugs, you may need an injury lawyer. Call our office today for a free and confidential case evaluation. Your consultation is free and we will handle your inquiry with the utmost level of care and professionalism.
What are birth defects?
Birth defects are the result of abnormalities in the structure, function, or the chemical balances of a baby when they are born. These abnormalities often result in the physical and/or mental disability of the child and can result in death.
About 150,000 babies are born each year with birth defects. Many of these defects are thought to be the result of environmental factors such as drug or alcohol abuse, infections, or exposure to certain medications (7).
Three major types of birth defects:
Structural Abnormalities When part of the babys body is either missing or deformed (can be internal or external). Common examples of structural abnormalities are heart defects, which affect around 1 out of 125 babies born and are the leading cause of abnormality-related infant deaths.
Metabolic Abnormalities - Metabolic abnormalities are birth defects from genetic factors, which result in the child being able to produce enzymes necessary to sustain a normal, healthy life and occur with far less frequency (about 1 in 3,500 infants are affected) than structural abnormalities.
Congenital Infections Infections in the mother that cause birth defects in children. Sexually transmitted diseases are an example of congenital infections that may cause defects in babies if the mother contracts one of the diseases early on in pregnancy or prior to conception.
What are SSRIs?
Paxil is an SSRI, which stands for selective serotonin reuptake inhibitor. SSRIs are the newest and most popular form of antidepressant drugs on the market. SSRIs have largely replaced the antidepressants of old (tricyclics and monoamine oxidase inhibitors), which interfered with neurotransmitters and receptor sites all over the brain and resulted in many undesirable side effects.
SSRIs, as their name implies, focus specifically on serotonin. The brain will release serotonin and then reabsorb it (known as reuptake) so it can be used at a later time. Physiological depression occurs when the brain doesnt have enough serotonin to maintain a stable mood; interfering with the reuptake of this chemical back into the brain (which is the design and function of SSRIs) allows for more messages to be sent throughout the brain and results in a steadier, happier mood.
What should I do if I took Paxil?
The FDA recommends, Healthcare professionals are advised to carefully weigh the potential risks and benefits of using [Paxil] in women during pregnancy and to discuss these findings as well as treatment alternatives with their patients (1).
Do not stop taking any prescription medications without first consulting a doctor. If you or someone you love has taken Paxil and has had a child with birth defects, contact our law offices immediately for a free and confidential case evaluation today. We want to help.
Sources:
1. The Food and Drug Administrations 2005 Safety Alerts for Drugs, Biologics, Medical Devices, and Dietary Supplements
2. Paxils Birth Defects Warning Strengthened from WebMD
3. FDA Advising of Risk of Birth Defects with Paxil
4. What Does Paxil Treat?
5. Consumer Affairs FDA Warns Paxil Users of Birth Defect Risks.
6. New Warning Issued on Paxil by Amanda Gardner, HealthDay Reporter.
7. Birth Defects from the March of Dimes Perinatal Data Center. Maternal, Infant, and Child Health in the United States, 2001. Consult with your physician if you have questions concerning this medication. This article is for informational purposes only. It is not intended to constitute medical advice and should not be viewed as such. For medical advice, you should always consult with your physician.
Paxil® is a registered trademark of GlaxoSmithKline and is used here only to identify the product in question.
This law firm is not associated with, sponsored by, or affiliated with The Food and Drug Administration, HealthDay, WebMD, GlaxoSmithKline, Forbes Magazine, or the March of Dimes.
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(AP)
(26-Apr-08)
!["Tim]("http://d.yimg.com/us.yimg.com/p/ap/20080426/capt.0a44a3dbd4f74f0babf0c6138b3408e4.medical_marijuana_transplants_waet103.jpg?x=130&y=77&q=85&sig=swYhNEFNskmgqeQ_iYL6wA--") AP - Timothy Garon's face and arms are hauntingly skeletal, but the fluid building up in his abdomen makes the 56-year-old musician look eight months pregnant.
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Federal panel seeks clearer warnings on Lasik eye surgery
(AP)
(26-Apr-08)
!["David]("http://d.yimg.com/us.yimg.com/p/ap/20080425/capt.b99c6262c2a04e969913baaf088063a9.lasik_surgery_mdla102.jpg?x=88&y=130&q=85&sig=WC2F.47kWbvGk1cI01o1pw--") AP - In fury and despair, patients harmed by Lasik eye surgery told federal health advisers Friday of severe eye pain, blurred vision and even a son's suicide. The advisers recommended that the government warn more clearly about the risks of the hugely popular operations.
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Veterans Affairs official denies cover-up of suicide rates
(AP)
(26-Apr-08)
AP - A top-ranking official at the Department of Veterans Affairs defends the agency's treatment of disabled veterans and denies the agency has tried to cover up the number of veterans committing suicide. more >
C-section delivery may raise risk of stroke (25-Apr-08)
NEW YORK (Reuters Health) - Pregnant women who have a cesarean delivery appear to be more likely to suffer a stroke during the following year than women who give birth normally, researchers in Taiwan have shown. ![]("http://feeds.reuters.com/~a/reuters/healthNews?i=VCr5gd")
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Forty years on, abortion battle rages in Britain
(Reuters)
(25-Apr-08)
!["A]("http://d.yimg.com/us.yimg.com/p/nm/20080425/2008_04_24t212143_450x334_us_britain_abortion.jpg?x=130&y=96&q=85&sig=pOYn3aXllZ9B.gmBs92Yxw--") Reuters - Pro-choice campaigners mark 40 years of legal abortion in Britain next week, but say their hard-won right is under pressure from pro-life activists trying to lower the 24-week limit for the termination of pregnancy.
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Forty years on, abortion battle rages in Britain (24-Apr-08)
LONDON (Reuters) - Pro-choice campaigners mark 40 years of legal abortion in Britain next week, but say their hard-won right is under pressure from pro-life activists trying to lower the 24-week limit for the termination of pregnancy. ![]("http://feeds.reuters.com/~a/reuters/healthNews?i=o2VJ7D")
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Mom's diet may play role in whether baby is boy or girl
(AP)
(24-Apr-08)
!["This]("http://d.yimg.com/us.yimg.com/p/afp/20080423/capt.cps.mze15.230408110636.photo00.photo.default-379x512.jpg?x=96&y=130&q=85&sig=WdG0RLmk0ZjYT0akYnKJ6g--") AP - Snips and snails and puppydog tails ... and cereal and bananas? That could be what little boys are made of, according to surprising new research suggesting that what a woman eats before pregnancy influences the gender of her baby.
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Risk of depression dims hopes for anti-addiction pills
(AP)
(23-Apr-08)
!["Margaret]("http://d.yimg.com/us.yimg.com/p/ap/20080423/capt.88cc36cf9684425aa02e8588fdf1bf7b.super_pills_ny451.jpg?x=130&y=86&q=85&sig=RNrWftMa2ztsNkVJrfxPfg--") AP - Two years ago, scientists had high hopes for new pills that would help people quit smoking, lose weight and maybe kick other tough addictions like alcohol and cocaine.
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Mother's diet can help determine sex of child: study
(AFP)
(23-Apr-08)
!["This]("http://d.yimg.com/us.yimg.com/p/afp/20080423/capt.cps.mzc22.230408023204.photo00.photo.default-379x512.jpg?x=96&y=130&q=85&sig=yBv5F5Kh3VqZu0x0rCCzmg--") AFP - Oysters may excite the libido, but there is nothing like a hearty breakfast laced with sugar to boost a woman's chances of conceiving a son, according to a study released Wednesday.
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Democrats seek resignation of top VA mental health official
(AP)
(22-Apr-08)
AP - Two Democratic senators on Tuesday called for the chief mental health official of the Veterans Affairs Department to resign, saying he tried to cover up the rising number of veteran suicides. more >
Extra Pounds During and Between Pregnancies Can Pose
Problems
(HealthDay)
(20-Apr-08)
HealthDay - SATURDAY, April 19 (HealthDay News) -- Pregnancy has long been considered a kind of gastronomical free-for-all. After all, a pregnant woman has to nourish two bodies with the food she eats, right? more >
Health Tip: Coping With Migraines During Pregnancy
(HealthDay)
(18-Apr-08)
HealthDay - (HealthDay News) -- Some women who are prone to migraines find that the headaches weaken during pregnancy, while other migraine suffers find that pregnancy increases the severity of their migraines, the American Pregnancy Association says. more >
Study: Gender, other factors guide preemies' survival
(AP)
(17-Apr-08)
!["Clara]("http://d.yimg.com/us.yimg.com/p/ap/20080416/capt.31d3dc07545a454eb2454a0aa27212d5.extreme_preemies_tnbw101.jpg?x=130&y=97&q=85&sig=G7rKYUSDe3zCxxZZ.sGuog--") AP - Doctors now have a better way of helping parents make an agonizing decision Â- whether to take heroic steps to save a very premature baby. The number of weeks in the womb has generally been the chief factor.
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Most older suicide victims not on antidepressants (15-Apr-08)
NEW YORK (Reuters Health) - Just one in five adults, 55 years and older, who commit suicide are using antidepressants at the time of their death, according to a report in the Journal of Epidemiology and Community Health. ![]("http://feeds.reuters.com/~a/reuters/healthNews?i=v0y0u4")
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Comparing Herschel Walker's Mental Disorders, Suicide Attempts ... - Associated Content (15-Apr-08)
Comparing Herschel Walker's Mental Disorders, Suicide Attempts ...Associated Content, CO - 12 hours agoI did and was put on medicine: Lexapro and Seroquel. I had nearly lost my family because of this. My wife stood by my side to a point at which she did not ... more >
Most Online Rx Drug Searches Are For Depression Meds - Mediapost.com (15-Apr-08)
 Mediapost.com
Most Online Rx Drug Searches Are For Depression MedsMediapost.com, NY - 19 hours agoThat medications such as Lexapro, Effexor, Paxil and Seroquel made the list was not particularly surprising, says Kreiberg. "Those are categories that ... more >
Most Online Rx Drug Searches Are For Depression Meds - Mediapost.com (15-Apr-08)
Mediapost.com Most Online Rx Drug Searches Are For Depression MedsMediapost.com, NY - Apr 15, 2008That medications such as Lexapro, Effexor, Paxil and Seroquel made the list was not particularly surprising, says Kreiberg. "Those are categories that ... more >
Supreme Court turns down boy killer's - CNN International (14-Apr-08)
 CNN International
Supreme Court turns down boy killer'sCNN International - Apr 14, 2008His lawyers said Pittman was then given Paxil, a mild antidepressant no longer recommended for those under 18. In the midst of these episodes, the youngster ... more >
Supreme Court turns down boy killer's - CNN International (14-Apr-08)
CNN International Supreme Court turns down boy killer'sCNN International - 9 hours agoHis lawyers said Pittman was then given Paxil, a mild antidepressant no longer recommended for those under 18. In the midst of these episodes, the youngster ... more >
Supreme Court turns down boy killer's appeal - CNN (14-Apr-08)
CNN Supreme Court turns down boy killer's appealCNN - Apr 14, 2008His lawyers said Pittman was then given Paxil, a mild antidepressant no longer recommended for those under 18. In the midst of these episodes, the youngster ... more >
Supreme Court turns down boy killer's appeal - CNN (14-Apr-08)
CNN Supreme Court turns down boy killer's appealCNN - Apr 14, 2008His lawyers said Pittman was then given Paxil, a mild antidepressant no longer recommended for those under 18. In the midst of these episodes, the youngster ... more >
Kids of substance-using moms have smaller brains (14-Apr-08)
NEW YORK (Reuters Health) - A mother's substance use during pregnancy can mean a smaller brain for her child, according to a new study in Pediatrics. ![]("http://feeds.reuters.com/~a/reuters/healthNews?i=dcdSom")
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Supreme Court turns down boy killer's appeal - CNN International (14-Apr-08)
CNN International Supreme Court turns down boy killer's appealCNN International - Apr 14, 2008His lawyers said Pittman was then given Paxil, a mild antidepressant no longer recommended for those under 18. In the midst of these episodes, the youngster ... more >
Fewer U.S. teens are getting pregnant: study (14-Apr-08)
WASHINGTON (Reuters) - Fewer U.S. teens got pregnant in 2004 but more women in their 20s had out-of-wedlock pregnancies, according to new federal statistics released on Monday. ![]("http://feeds.reuters.com/~a/reuters/healthNews?i=Cd7HSF")
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Lawsuit claims "CSI" toy kits contain asbestos (11-Apr-08)
LOS ANGELES (Reuters) - A California asbestos awareness group sued CBS Corp, a toy maker and several retailers on Friday, claiming they sold toy crime-scene kits based on the hit CBS series "CSI: Crime Scene Investigation" that contained the cancer-causing substance. ![]("http://feeds.reuters.com/~a/reuters/healthNews?i=WFTvaS")
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Health Tip: Weight Gain During Pregnancy
(HealthDay)
(11-Apr-08)
HealthDay - (HealthDay News) - Women who are at a healthy body weight before pregnancy should gain between 25 pounds and 37 pounds, the American Pregnancy Association says. more >
Health Tip: Swelling During Pregnancy
(HealthDay)
(10-Apr-08)
HealthDay - (HealthDay News) - Production of additional fluids and blood during pregnancy sometimes leads to swelling in the woman's face, hands, legs, ankles and feet. more >
Infant heart defects tied to maternal smoking (09-Apr-08)
NEW YORK (Reuters Health) - A woman who smokes during pregnancy increases the risk that her child will be born with a heart defect, a new study published in Pediatrics shows. ![]("http://feeds.reuters.com/~a/reuters/healthNews?i=lT1yjk")
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Fetal Exposure to Substance Abuse Changes Brain Structure
(HealthDay)
(08-Apr-08)
HealthDay - MONDAY, April 7 (HealthDay News) -- Babies born to women who use cocaine, alcohol or tobacco during pregnancy may have brain structure changes that persist into early adolescence, a new U.S. study says. more >
Glaxo Fights Against Public Paxil Trials - Best Syndication (07-Apr-08)
 Best Syndication
Glaxo Fights Against Public Paxil TrialsBest Syndication, CA - 8 hours agoHis parents, Terri ONeal and Barry Bratt, filed a lawsuit alleging that, despite knowledge of suicide risks associated with Paxil prior to 1997, ... more >
Glaxo Fights Against Public Paxil Trials - Best Syndication (07-Apr-08)
Best Syndication Glaxo Fights Against Public Paxil TrialsBest Syndication, CA - Apr 7, 2008His parents, Terri ONeal and Barry Bratt, filed a lawsuit alleging that, despite knowledge of suicide risks associated with Paxil prior to 1997, ... more >
Glaxo Fights Against Public Paxil Trials - Best Syndication (07-Apr-08)
Best Syndication Glaxo Fights Against Public Paxil TrialsBest Syndication, CA - Apr 7, 2008His parents, Terri ONeal and Barry Bratt, filed a lawsuit alleging that, despite knowledge of suicide risks associated with Paxil prior to 1997, ... more >
Maternal exercise benefits mother and infant (07-Apr-08)
NEW YORK (Reuters Health) - Exercise during pregnancy has cardiovascular benefits not just for the mother but for the developing fetus as well, according to research presented Monday at the 121st annual meeting of the American Physiological Society, part of the Experimental Biology 2008 scientific conference. ![]("http://feeds.reuters.com/~a/reuters/healthNews?i=V6pzV8")
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Glaxo Fights Against Public Paxil Trials - OpEdNews (07-Apr-08)
Glaxo Fights Against Public Paxil TrialsOpEdNews, PA - 16 hours agoHis parents, Terri O'Neal and Barry Bratt, filed a lawsuit alleging that, despite knowledge of suicide risks associated with Paxil prior to 1997, ... more >
Stress won't boost risk of pregnancy complication (04-Apr-08)
NEW YORK (Reuters Health) - Being stressed out during the first half of pregnancy may be unhealthy, but it won't increase a woman's risk of developing a serious complication known as preeclampsia, Dutch researchers have found. ![]("http://feeds.reuters.com/~a/reuters/healthNews?i=9A7XbY")
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Health Tip: Prevent Back Problems After Pregnancy
(HealthDay)
(03-Apr-08)
HealthDay - (HealthDay News) - Back pain is a common complaint among new mothers. more >
Obesity During Pregnancy Carries Bigger Price Tag
(HealthDay)
(03-Apr-08)
HealthDay - WEDNESDAY, April 2 (HealthDay News) -- It is well-known that obesity increases the chances of medical complications during pregnancy, but now a new study shows it also puts a financial strain on the health-care system. more >
Seat belts protect unborn babies: study
(Reuters)
(02-Apr-08)
!["A]("http://d.yimg.com/us.yimg.com/p/nm/20080402/2008_04_02t005254_450x306_us_pregnancy_seatbelts.jpg?x=130&y=88&q=85&sig=60lCNp5oB70.933q9680Og--") Reuters - A pregnant woman who wears a seat belt greatly reduces the risk that her baby will die or be seriously hurt in a vehicle crash, according to a study that debunks the notion that seat belts are harmful to the fetus.
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Seat belts protect unborn babies: study (02-Apr-08)
WASHINGTON (Reuters) - A pregnant woman who wears a seat belt greatly reduces the risk that her baby will die or be seriously hurt in a vehicle crash, according to a study that debunks the notion that seat belts are harmful to the fetus. ![]("http://feeds.reuters.com/~a/reuters/healthNews?i=ccBaEO")
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Mom's fish intake may boost child's brain power (01-Apr-08)
NEW YORK (Reuters Health) - Preschoolers whose mothers regularly ate low-mercury fish during pregnancy may have sharper minds than their peers, a study suggests. ![]("http://feeds.reuters.com/~a/reuters/healthNews?i=bm8AHN")
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A Close Call for Botox User - Lawyers and Settlements (01-Apr-08)
A Close Call for Botox UserLawyers and Settlements - 18 hours ago"Because I was suffering from excessive drooling," says Susan, "which was a side effect of the drug Seroquel that I was taking for a disorder called ... more >
Psychiatric drugs causing weight gain: doctors - GlobalTV (30-Mar-08)
Psychiatric drugs causing weight gain: doctorsGlobalTV, Canada - Mar 30, 2008Paxil and other antidepressants known as selective serotonin reuptake inhibitors, have a weird effect. You lose weight at the beginning, ... more >
Psychiatric drugs causing weight gain: doctors - GlobalTV (30-Mar-08)
Psychiatric drugs causing weight gain: doctorsGlobalTV, Canada - Mar 30, 2008Paxil and other antidepressants known as selective serotonin reuptake inhibitors, have a weird effect. You lose weight at the beginning, ... more >
Psychiatric drugs causing weight gain: doctors - Vancouver Sun (30-Mar-08)
Psychiatric drugs causing weight gain: doctorsVancouver Sun, Canada - 12 hours agoPaxil and other antidepressants known as selective serotonin reuptake inhibitors, "have a weird effect. You lose weight at the beginning, ... more >
Health Tip: Managing After a Miscarriage
(HealthDay)
(29-Mar-08)
HealthDay - (HealthDay News)- The aftermath of a pregnancy loss is an extremely difficult and frustrating time for the affected couple. more >
The man who made lists to fend off depression (28-Mar-08)
LOS ANGELES (Reuters) - His mother suffered dark depressions and tried to dominate his life. His sister and daughter had severe mental problems, his father and wife died young and a beloved uncle committed suicide in his arms. ![]("http://feeds.reuters.com/~a/reuters/healthNews?i=0kFUHA")
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FDA probes Merck drug, possible suicides
(AP)
(28-Mar-08)
!["The]("http://d.yimg.com/us.yimg.com/p/rids/20080327/i/r1892277378.jpg?x=130&y=84&q=85&sig=WOHdEhhACQbRCvWdPNE7qA--") AP - The Food and Drug Administration said Thursday it is investigating a possible link between Merck's best-selling Singulair and suicide. FDA said it is reviewing a handful of reports involving mood changes, suicidal behavior and suicide in patients who have taken the popular allergy and asthma drug.
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FDA probes suicide risk in Merck's Singulair (27-Mar-08)
WASHINGTON (Reuters) - U.S. health regulators are probing a possible connection between Merck & Co Inc's blockbuster Singulair asthma drug and suicidal behavior in adults and children, the Food and Drug Administration said on Thursday. ![]("http://feeds.reuters.com/~a/reuters/healthNews?i=8d7uvS")
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Too Little Vitamin D May Soften Baby's Skull
(HealthDay)
(27-Mar-08)
HealthDay - WEDNESDAY, March 26 (HealthDay News) -- Vitamin D deficiency during pregnancy may be linked to a softening of bones in a baby's skull, Japanese researchers report. more >
C-sections linked to cervix length: study (27-Mar-08)
BOSTON (Reuters) - Doctors who use age, weight and other factors to predict if a pregnant woman will need a Caesarean section to deliver her baby have a new gauge: the length of the cervix, researchers said on Wednesday. ![]("http://feeds.reuters.com/~a/reuters/healthNews?i=adaUX0")
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Maternal antibodies may contribute to autism (26-Mar-08)
NEW YORK (Reuters Health) - Along with genetic, metabolic and environmental factors, a team of researchers at Johns Hopkins University in Baltimore suggest that autism may also be caused or triggered by maternal antibodies that cross over through the placenta and are directed against the brain tissues of the fetus, adversely affecting brain development. ![]("http://feeds.reuters.com/~a/reuters/healthNews?i=xNRnYH")
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Fla. teen dies during breast surgery
(AP)
(26-Mar-08)
AP - A South Florida teenager who was captain of her high school cheerleading squad and had plans to become a doctor died after corrective breast surgery, a family attorney said Tuesday. more >
Breastfed babies not iron-deficient at 6 months (25-Mar-08)
NEW YORK (Reuters Health) - Full-term babies who are exclusively breastfed are not at heightened risk of low iron stores by the age of 6 months, even if their mothers were iron-deficient during pregnancy, a new study shows. ![]("http://feeds.reuters.com/~a/reuters/healthNews?i=sbdd8I")
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