FDA Warns Pregnant Women About Migraine Drugs

Medicines containing valproate linked to lower IQs in children, agency says

By Robert Preidt

HealthDay Reporter

MONDAY, May 6 (HealthDay News) -- Pregnant women who struggle with migraine headaches should never use medicines containing the ingredient valproate because they can lower the IQ scores of their children, the U.S. Food and Drug Administration said Monday.

The new warning will be included on the labels of medicines that contain valproate. These medicines already carry a boxed warning about fetal risk, including birth defects. Valproate products include valproate sodium (Depacon); divalproex sodium (Depakote, Depakote CP, and Depakote ER); valproic acid (Depakene and Stavzor); and their generic versions.

"Valproate medications should never be used in pregnant women for the prevention of migraine headaches because we have even more data now that show the risks to the children outweigh any treatment benefits for this use," Dr. Russell Katz, director of the division of neurology products in the FDA's Center for Drug Evaluation and Research, said in an agency news release.

Valproate medicines have several FDA-approved uses including: prevention of migraines, treatment of epileptic seizures and treatment of bipolar disorder.

This new warning was issued after a study found that children whose mothers took valproate drugs to protect against epilepsy during pregnancy scored eight to 11 points lower on IQ tests at age 6 than children who were exposed to other antiepileptic drugs in the womb.

It's not known if there's a specific time during pregnancy when valproate can result in decreased IQ in children. The women in the study took the antiepileptic valproate drugs throughout their pregnancies, the FDA said.

Valproate may have some value in treating bipolar disorder and epileptic seizures in pregnant women, but should only be taken if other medications have failed to control the symptoms or are otherwise unacceptable, according to the agency.

The FDA also said that:

Women who can become pregnant should not use valproate unless it is essential to managing their medical condition.Women of childbearing age taking valproate products should use effective birth control.Women who are pregnant or who become pregnant while taking valproate medications should talk to their health-care professional immediately. Women should not stop taking their medication without talking to their health-care professional because stopping treatment suddenly can cause serious and life-threatening medical problems for the woman or the fetus.

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Heavier Pregnant Women Tend to Deliver Prematurely

In large Swedish study, risk rose along with the mother's weight

By Dennis Thompson

HealthDay Reporter

TUESDAY, June 11 (HealthDay News) -- Overweight or obese women who are pregnant are more likely to give birth prematurely, and the risk of preterm delivery increases with their amount of excess weight, according to a study of more than 1.5 million deliveries in Sweden.

Researchers speculate that the health problems associated with overweight and obesity -- high blood pressure, insulin resistance, high cholesterol, increased chance of infection -- have a direct impact on a woman's ability to carry their child to term, according to the study, which was published in the June 12 issue of the Journal of the American Medical Association.

Birth of an infant prior to 37 weeks of gestation is the leading cause of infant mortality, neonatal illness and long-term disability in children, said researchers led by Dr. Sven Cnattingius of the Karolinska Institute in Stockholm.

A U.S. expert not involved with the study said he wasn't surprised by the findings.

"This just reinforces the fact that the complications of obesity and additional weight gain are deleterious to both mother and fetus," said Dr. Raul Artal, a professor and chairman of the department of obstetrics, gynecology and women's health at the Saint Louis University School of Medicine.

Artal said this study, along with previous research, makes the case that overweight and obese women who are pregnant can protect the health of their unborn child by maintaining their current weight or even shedding some pounds.

"The concept that we propagated for years that pregnancy is not a good time for weight loss and physical activity is wrong," he said.

For the study, researchers analyzed the records of 1.59 million births between 1992 and 2010, reviewing the body-mass index (BMI) of the women at their first prenatal doctor's visit as well as information recorded following birth about health risks, maternal diseases and pregnancy complications.

BMI is a measure of body fat based on height and weight.

The statistics came from the Swedish Medical Birth Register, which maintains detailed data on all births in that nation and serves as a valuable resource for researchers, a U.S. expert said.

"There's a lot of good obstetric data that comes out of Sweden because of that register," said Dr. Russ Fothergill, vice chairman of the department of obstetrics and gynecology at Scott and White Healthcare in Temple, Texas.

The researchers found that the risk of extremely premature (22 to 27 weeks), very premature (28 to 31 weeks) and moderately premature (32 to 36 weeks) deliveries increased with a woman's BMI.

The authors said that even though the study is Swedish, the results can be generalized to other populations with similar or higher rates of maternal obesity or preterm delivery.

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Pregnant Women Under Stress May Be at Higher Risk for Stillbirth

Title: Pregnant Women Under Stress May Be at Higher Risk for Stillbirth
Category: Health News
Created: 3/29/2013 2:35:00 PM
Last Editorial Review: 4/1/2013 12:00:00 AM

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Working While Pregnant Won't Harm the Baby, Study Finds

Title: Working While Pregnant Won't Harm the Baby, Study Finds
Category: Health News
Created: 3/25/2013 4:35:00 PM
Last Editorial Review: 3/26/2013 12:00:00 AM

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Bowel Issues Affect 3 Out of 4 Pregnant Women

These problems don't significantly affect quality of life, study says

By Mary Elizabeth Dallas

HealthDay Reporter

FRIDAY, May 24 (HealthDay News) -- Nearly three out of four pregnant women experience bowel problems such as constipation and diarrhea, but these issues don't significantly affect their quality of life, a new study finds.

Researchers from Loyola University Medical Center in Maywood, Ill., noted that these bowel issues are due to physiological and hormonal changes that occur during pregnancy. Nutritional supplements that women take during pregnancy also can play a role. The study authors added that since women expect these problems to arise during pregnancy, they're better able to tolerate them.

The study included 104 women in their first trimester of pregnancy and 66 women in their third trimester. They completed two questionnaires: one asking about the bowel disorders they experienced and another on how these problems affected their quality of life. Specifically, the women were asked if their bowel issues made life less enjoyable, limited what they could wear or eat, or made them feel embarrassed, vulnerable, angry, isolated or depressed.

The study revealed that 72 percent of the first-trimester respondents and 61 percent of the third-trimester respondents had one or more bowel disorders, including constipation, diarrhea, bloating and irritable bowel syndrome.

On a scale of one to 100, with 100 being the least impact on quality of life, the women's average score was 94.9. The researchers said two issues had a measurable effect on quality of life: Both constipation and bloating reduced the quality-of-life score by approximately four points.

Study senior author Dr. Scott Graziano, associate professor of obstetrics and gynecology at the Loyola University Chicago Stritch School of Medicine, advises pregnant women to drink plenty of fluids and consume 25 to 30 grams of fiber daily. The study found that pregnant women consume only 16 to 17 grams of fiber a day. Stool softeners and suppositories are safe for pregnant women, Graziano said.

The study's findings were presented earlier this month at the American College of Obstetricians and Gynecologists' annual meeting in New Orleans. Data and conclusions from studies presented at medical meetings should be viewed as preliminary until published in a peer-reviewed journal.

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Pregnant Kate Middleton holiday photos set to be published by Italian magazine

St. James’s Palace has condemned an Italian magazine’s plans to publish new holiday photos of a pregnant Kate Middleton.

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Whooping Cough Vaccine for Pregnant Women Among New Recommendations

MONDAY, Jan. 28 (HealthDay News) -- The U.S. Centers for Disease Control and Prevention and the American Academy of Pediatrics have released new vaccine guidelines for 2013.

One change is a recommendation for women to receive a dose of the whooping cough (pertussis) vaccine with each pregnancy. Another is the suggestion that mild egg allergy need no longer prevent people from getting the flu vaccine under certain circumstances.

The guidelines also clarify the use of the pneumococcal vaccine -- which protects against sometimes life-threatening meningitis, pneumonia and blood infections -- in certain vulnerable populations.

Current levels of vaccination in adults are low, according to the CDC's Advisory Committee on Immunization Practices. Because of this, the committee recommended that providers review patients' vaccination records and recommend needed vaccines.

"It's so important to adhere to these immunization schedules. People need to understand: These schedules are put together with great care and discussion and review of scientific data," said Dr. H. Cody Meissner, a member of the American Academy of Pediatrics committee that makes vaccine recommendations.

Meissner said sometimes parents will ask to alter the way vaccines are given, requesting things like a half-dose now and the rest of the dose at a later time. "We just don't know if vaccines work at half-doses. It's critically important to adhere to the schedule," he said.

The latest vaccine recommendations can be found in the Feb. 5 issue of the journal Annals of Internal Medicine and the February issue of the journal Pediatrics.

The most notable change is the new recommendation that pregnant women -- whether adolescent or adult -- receive a booster dose of the tetanus, diphtheria and acellular pertussis (TDaP) vaccine during each pregnancy. Ideally, this booster will be given between 27 and 36 weeks of gestation.

"We're seeing more pertussis now than we have in earlier years. When the final numbers are in for 2012, the number of reported cases will probably be around 35,000," Meissner said. "But the actual number could be far more than that, because they don't all get documented. There were about 20 deaths last year, primarily children in the first two to three months of life."

Meissner, who also is chief of pediatric infectious disease at the Floating Hospital for Children at Tufts Medical Center in Boston, said that children in this age group don't yet have protection from vaccines. Since the vaccine crosses through the placenta, an immunization given later in the pregnancy should offer a high level of immunity to the baby.

He added that it's also a good idea for anyone who will be around the baby, including the father, siblings and grandparents, to be sure they're up to date on their vaccines.

Another expert said the resurgence of whooping cough is most likely due to a change in vaccine design that got rid of many side effects, but did so at the cost of long-term effectiveness.

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