Trusted Information for Healthy Pregnancies
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Recalls of children’s medicines spark worries
May 4th
Parents may be worried by this weekend's recall of dozens of versions of Children's Tylenol and several other infants' and children's medications made by Johnson & Johnson's McNeil Consumer Healthcare division.
Parents voiced fears to pediatricians and pharmacists, and asked questions about the affected products - two dozen formulations of Tylenol, known generically as acetaminophen, along with liquid formulations of Motrin (ibuprofen), Benadryl (diphenhydramine), and Zyrtec (cetirizine).
So far, the advice for parents, at least, is clear: McNeil says they should stop using any of the affected products - essentially, any liquid formulation of those medications made by McNeil, which is based in Fort Washington.
Doctors and pharmacists recommend that parents replace the medications with generics of the same drugs or other brand-name versions, none of which are affected by the recall. Consumers can obtain refunds directly from McNeil or from at least some pharmacies.
What went wrong? Little is known. McNeil, in announcing the voluntary recall late Friday "in consultation with the U.S. Food and Drug Administration," says some of the products "may not meet required quality standards."
McNeil says the children's products may have "a higher concentration of active ingredients than is specified." They may also have contaminants that spokesman Marc Boston describes as "solidified product ingredients or manufacturing residue, such as tiny metal specks." He declined to say what metal or metals had been found.
Nor is it clear if McNeil is responding with an abundance of caution or faces greater concerns.
"They've had a lot of problems," says Don Mays, senior director of product safety for Consumer Reports. "It seems like they need better quality control and process control in the manufacture of these products."
This is the second major recall of children's Tylenol products in the last year. In September, more than 20 versions were recalled because of possible bacterial contamination.
Was there a danger to my child? It's impossible to say for sure, but McNeil is suggesting not.
"We have received consumer inquiries," Boston says. "But I can confirm that the recall is not being undertaken on the basis of adverse medical events" reported to the company.
Nor has the FDA so far suggested otherwise.
"While the potential for serious health problems is remote, Americans deserve medications that are safe, effective, and of the highest quality," FDA Commissioner Margaret A. Hamburg said in a statement Saturday. "We are investigating the products and facilities associated with this recall and will provide updates as we learn more."
By contrast, when McNeil voluntarily recalled some related products in January because of a contaminant it said caused "an unusual moldy, musty, or mildew-like odor," the company acknowledged "a small number of cases" of reactions such as nausea, stomach pain, vomiting, or diarrhea.
What if I'm worried? David Pollack, a Children's Hospital pediatrician and senior physician at the hospital's Care Network in Delaware County, says parents should report any concerns to their pediatrician, who will then notify the FDA and McNeil.
Based on the information available, Pollack said, "I could certainly believe that there's been no adverse effects on kids."
Can you substitute an adult version? Pollack and McNeil both warn against doing this, even with older children who can swallow pills, because of the danger of incorrect dosages.
"Every day we're faced with a misdosage when a mother is trying to convert an adult dosage to her kids," Pollack says. "If it's not really designed for children, we would tell them not to use it."
So what are the alternatives? Doctors and pharmacists say generic versions are widely available and considerably less expensive.
For more information on the recall or how to obtain a refund, go to www.mcneilproductrecall.com. You can also call 1-888-222-6036, but the company says it has been overwhelmed with calls and may not be able to answer.
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Less sunlight in first trimester of pregnancy linked to MS
Apr 30th
Region of birth and lower levels of exposure to ultraviolet radiation during the first trimester of pregnancy were both independently associated with an increased risk of multiple sclerosis (MS) in adult life, shows research published in the BMJ.
The study was conducted across five states and one territory in Australia, among people born between 1920 and 1950 who were still alive at the time of the 1981 population census. A prevalence survey of MS had also been carried out in 1981.
There were 1524 patients with multiple sclerosis born in Australia 1920-50 from a total population of 2 468 779. Researchers analyzed their data by sex, month and year of birth and region of birth.
As expected, MS was more than twice as common among women as among men.
Overall, people born in November-December (first trimester in the Australian winter) had a third higher risk of subsequently developing MS than those born in May-June (first trimester in the summer).
When researchers analyzed their data by region of birth, they found that people born in regions with the lowest average levels of ambient ultraviolet radiation had a more than four times greater risk of subsequently developing MS than those born in the sunniest regions.
The association with month of birth was accounted for by the month- and region-specific ambient ultraviolet radiation during the first trimester – the effect of month of birth did not persist after adjustment for first trimester ultraviolet radiation.
The authors discuss the implications for prenatal care, and conclude: “Vitamin D supplementation for the prevention of multiple sclerosis might also need to be considered during in utero development.”
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Mom’s anemia may raise schizophrenia risk in offspring
Feb 10th
Children of mothers who had been diagnosed with anemia during pregnancy, most likely due to iron deficiency, had a significantly elevated risk of developing the mental disorder, the study's lead researcher Dr. Holger Srensen of the University Hospital of Copenhagen in Demark, told Reuters Health by email.
Iron is necessary for the production of hemoglobin, a protein that distributes oxygen throughout the body. Because a pregnant woman carries an additional set of organs and tissues -- and almost 50 percent more blood -- she needs extra iron to ensure that enough oxygen gets around.
"We speculate that maternal iron deficiency may disrupt essential pathways that affect the delivery of oxygen and nutrients to the fetus," Srensen said. Earlier research has suggested that a failure to meet the iron demands of a developing brain might heighten a child's vulnerability to disorders such as schizophrenia.
To further investigate this potential link, Srensen and colleagues analyzed the psychiatric outcomes of a large group of Danish children born between 1978 and 1998 -- the biggest cohort in which the relationship has been examined. Each child was followed from age 10 until the onset of schizophrenia, death or the study's closure on December 31, 2008.
Among 1,115,752 newborns, 17,940 (1.6 percent) were exposed to anemia in the womb. A total of 3,422 -- including 41 from the exposed group -- went on to develop schizophrenia, according to the report published in the journal Schizophrenia Bulletin.
After accounting for differences between the two groups and other relevant factors, including the parents' ages and history of mental illness, exposure to anemia in the womb was associated with a 60 percent increased risk of schizophrenia in offspring during the 20 years of the study.
The researchers further concluded that 0.58 percent of schizophrenia cases (a total of about 20 diagnoses) could have been prevented had there been no cases of anemia among the mothers.
These figures may be underestimates of anemia's true impact, according to Srensen and colleagues. It is possible that some pregnant women received anemia diagnoses and treatment from general practitioners outside the hospital, and therefore outside of the Danish registry used for the study.
Schizophrenia diagnoses may have been under reported as well. Even the oldest cohort members were only followed until age 30. Rates of schizophrenia peak around age 22 or 23, noted Srensen, so the study "may have missed around 50 percent of cases with a later onset."
The researchers also lacked access to the women's precise hemoglobin levels, which prevented assessment of the relative severity of anemia.
Despite its unresolved relationship with schizophrenia, prevention and treatment of maternal anemia remains straightforward. "Checking for iron-deficiency anemia (or anemia from other causes), and correcting a deficit," Srensen said, "is relatively simple in a clinical setting."
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Milk in pregnancy may lower MS risk
Feb 10th
Mothers-to-be can reduce their babies' risk of developing multiple sclerosis in later life by drinking milk, research suggests.
The link emerged from a study of 35,794 female nurses whose mothers provided information about their diet during pregnancy. Of the nurses taking part, 199 developed multiple sclerosis (MS) over a 16-year period.
The researchers found that the risk of MS was lower among women born to mothers who drank a lot of milk while pregnant. A similar trend was seen for vitamin D. Mothers who had a relatively high vitamin D intake during pregnancy also gave birth to daughters with a reduced risk of MS.
Dr Fariba Mirzaei, from the Harvard School of Public Health in Boston, US, who led the study, said: "The risk of MS among daughters whose mothers consumed four glasses of milk per day was 56% lower than daughters whose mothers consumed less than three glasses of milk per month.
"We also found the risk of MS among daughters whose mothers were in the top 20% of vitamin D intake during pregnancy was 45% lower than daughters whose mothers were in the bottom 20% for vitamin D intake during pregnancy."
She added: "There is growing evidence that vitamin D has an effect on MS. The results of this study suggest that this effect may begin in the womb."
Exposure to sunlight, oily fish such as salmon and mackerel and fortified milk are key sources of vitamin D.
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Childhood asthma in premature babies linked to pregnancy bug
Feb 2nd
A common complication during pregnancy may predispose children born prematurely to asthma, a large study reports today.
The condition, chorioamnionitis, is inflammation of the fetal membranes and amniotic fluid from a bacterial infection. It is thought to be linked to more than half of all preterm births, before 37 weeks' gestation, scientists write in today's Archives of Pediatric and Adolescent Medicine.
The infection may have ascended to the uterus from the mother's genital tract or traveled through her bloodstream from a more remote site, such as her gums or upper respiratory tract, says lead author Darios Getahun, a scientist at Kaiser Permanente Southern California's Department of Research and Evaluation in Pasadena.
In animals, chorioamnionitis has been shown to cause lung and brain damage in offspring, Getahun says. Scientists also have found lung scarring in infants who died after pregnancies complicated by the condition.
Getahun and his co-authors analyzed electronic health records for all singleton children born at Kaiser's Southern California hospitals in 1991 to 2007, a total of 397,852. Of those, 28,869 were preterm.
Among children born full-term, chorioamnionitis wasn't linked to an increased risk of being diagnosed with asthma by age 8. But among those born prematurely, the condition was associated with double the risk of childhood asthma in blacks, a 70% increase in Hispanics and a 66% increase in whites. The researchers observed these differences even after accounting for other possible risk factors such as whether the mother smoked or had asthma herself. Only in Asian/Pacific Islanders preemies did chorioamnionitis not seem to make a difference in childhood asthma risk.
Getahun speculates that chorioamnionitis wasn't related to asthma risk in full-term children because their mothers might not have had it as long as those born prematurely. But, he adds, his team didn't have information about how early in their pregnancy women were diagnosed.
Diagnosing the condition is tricky, Getahun says, because symptoms — fever in the mother, tenderness or pain in the uterus, foul-smelling amniotic fluid — aren't definitive, and some women never exhibit symptoms. Getahun's team is now trying to find a marker in the mother's blood that would signify her symptoms are because of chorioamnionitis.
A study of 1,096 children published in 2008 found a higher risk of wheezing by age 2 in preemies whose mothers had had chorioamnionitis.
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Mothers with Celiac Disease Face a Higher Risk of Underweight and Early-term Births
Jan 25th
Women with celiac disease face greater risks for adverse pregnancy outcomes. A team of researchers recently set out to examine the effects of treated and untreated maternal celiac disease on infant birthweight and preterm birth. Among their findings are that expectant mothers with celiac disease face a higher risk of underweight and early-term birth than those without celiac disease.
For their data, researchers used a population-based cohort study of all live births in Denmark between 1 January 1979 and 31 December 2004. During that period, 836,241 mothers gave birth to a total of 1,504,342 babies. Mothers with diagnosed celiac disease gave birth to 1105 of those babies, while 346 were born to women with undiagnosed celiac disease.
The team considered mothers with diagnosed celiac disease to be following a gluten free diet, and those with undiagnosed celiac disease to be on a gluten-inclusive diet. The team measured outcomes based on birthweight, small for gestational age, very small for gestational age and preterm birth. They then compared the results for the treated and untreated celiac disease mothers with those of a celiac-free reference group.
The research team found that mothers with untreated celiac disease gave birth to smaller babies [difference = –98 g (95% CI: –130, –67)], with a higher risk of SGA [OR = 1.31 (95% CI: 1.06, 1.63)], VSGA [OR = 1.54 (95% CI: 1.17, 2.03)] and early birth [OR = 1.33 (95% CI: 1.02, 1.72)] compared with women with no celiac disease.
The good news is that mothers with treated celiac disease showed no increased risk of reduced mean birthweight, or of delivering SGA and VSGA infants or preterm birth compared with mothers with no celiac disease.
From the results, the research team concluded that untreated maternal celiac disease increases the risk of low birthweight, SGA and VSGA, and preterm birth.
Diagnosis and treatment of maternal celiac disease with a gluten-free diet seems to return the birthweight and preterm birth rate to one comparable to women without celiac disease.
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Pregnancy in Winter Months Increases Risk of Newborn Neurological Problems
Jan 11th
Sunlight is important for our health. In these days when people are afraid of skin cancer and smother on sunscreen, Vitamin D absorption has been reduced. Vitamin D is also vital to infant development, and new research suggests that mothers who are pregnant during winter months have an increased risk of delivering babies with neurological issues. Of particular concern is the increase in babies with multiple sclerosis (MS) born in April.
According to research published in the European Journal of Neurology, lack of vitamin D in pregnancy "predisposes" individuals to MS. The Telegraph reports:
Vitamin D, which is largely gained through sunlight and food, is known to regulate a gene that can predispose individuals to MS. If the gene is passed on to the unborn child, without being regulated by a sufficient amount of vitamin D, it could “hard wire” them to develop the disease in later life…
Professor George Ebers, from Oxford University’s department of clinical neurology at the John Radcliffe Hospital, said: “The difference [in developing MS in Scotland] between being born in April versus November is an astounding 50per cent. This is real, there’s no doubt of a seasonal link. There are different theories, but I think the April excess of births could be linked to a sunlight deficiency.
Should parents living in climates that lack winter sun try to conceive at times to avoid winter pregnancies? Researchers believe this may be prudent if there is a family history of neurological disorders, such as MS, but most women can simply take a vitamin D supplement.
Vitamin D has also been shown to be important in preventing the flu.
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Readmissions After Cesarean Higher Than Vaginal Delivery
Jan 8th
Hospital readmissions for women in the postpartum period are often due to infections, and women have a higher risk of readmission after cesarean than vaginal deliveries, according to research published in the January issue of the American Journal of Obstetrics & Gynecology.
Michael A. Belfort, M.D., of the Hospital Corporation of America (HCA) in Nashville, Tenn., and colleagues analyzed 222,751 deliveries in 2007 in 114 HCA hospitals to evaluate reasons for readmission after delivery.
Of this group, the researchers found that 2,655 women (1.2 percent) were readmitted within six weeks. Readmission was more common after cesarean than vaginal delivery (1.8 versus 0.83 percent). Hypertension and uterine and wound infections were the most common reasons for readmission, though readmissions for cholecystitis, appendicitis, and pneumonia were also notable.
"Our data confirm that, although readmissions in the first six weeks after delivery are uncommon, cesarean delivery carries with it roughly twice the risk for readmission as does vaginal birth," the authors write. "Perhaps of most interest was our observation of a significantly higher rate of hospital readmission for cholecystitis, appendicitis, and pneumonia in the first few postpartum weeks than would be expected by chance. None of these conditions has ever before been linked causally to pregnancy or delivery."
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Prompt treatment beneficial for pregnant and postpartum women with H1N1
Dec 31st
Delayed treatment of suspected influenza A (H1N1) illness among pregnant women may result in a four-fold risk of intensive care admission or death, according to results of a recent study.
Regardless of rapid antigen test results, prompt evaluation and antiviral treatment should be considered for pregnant or postpartum women displaying influenza A (H1N1)-like symptoms, according to researchers from the California Department of Public Health.
The study was a review of records for women of reproductive age who had been hospitalized or died from influenza A (H1N1) between April 23 and August 11, 2009.
The study involved 94 pregnant women, 137 non-pregnant women and 8 postpartum women who had delivered <2 weeks prior. False negative results for rapid antigen tests were observed in 38% of patients.
Among 94 pregnant women, 95% were in the second or third trimester. Risk factors for complications from influenza other than pregnancy were observed in 32 of 93 (34%) of those pregnant women.
Early antiviral treatment was defined as treatment <2 days after the onset of symptoms. Pregnant women treated later than this had an RR of 4.3 for admission to an ICU or death.
Intensive care was required for 18 pregnant women and four postpartum women (total, 22 of 102 [22%]). There were eight deaths (8%).
Of six deliveries which took place in the ICU, four were emergency cesarean deliveries.
The specific mortality ratio associated with influenza A (H1N1), which the researchers defined as the number of maternal deaths per 100,000, was 4.3.
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No Link Seen Between Acetaminophen, Birth Defects
Dec 21st
New study findings offer reassurance to pregnant women that acetaminophen does not appear to raise the risk of birth defects.
Acetaminophen is the active ingredient in Tylenol and certain other painkillers, and is often found in over-the-counter cold and flu remedies. Taken as directed, acetaminophen is considered safe during pregnancy, making it the medication of choice for pregnant women's body aches and fevers.
However, there are still some questions about whether the drug can contribute to birth defects. Studies looking at birth defects as a broad group have either found no link to acetaminophen use or have yielded inconclusive findings.
Some research, meanwhile, has suggested that the drug may be linked to a higher risk of a birth defect called gastroschisis -- but other studies have found no such connection. Gastroschisis refers to a defect in the abdominal wall that allows the intestines to protrude; it has been linked to aspirin use during pregnancy.
In the new study, researchers analyzed data from a large U.S. study that included more than 11,600 children born with congenital defects such as spina bifida, cleft lip and various defects affecting the brain, heart, lungs, limbs and gastrointestinal system. They were compared with 4,500 children born with no major anomaly.
Overall, the study found, there was no evidence linking mothers' acetaminophen use in the first trimester to a heightened risk of any birth defect.
In fact, women who took the medication to treat a first-trimester fever had a lower risk of certain birth defects -- including gastroschisis -- than women who did not treat their fevers with acetaminophen.
Researchers led by Dr. Marcia L. Feldkamp, of the University of Utah in Salt Lake City, report the findings in the January 2010 issue of the journal Obstetrics & Gynecology.Among women who had fevers in early pregnancy, babies born to those who used acetaminophen had a 65 percent to 83 percent lower risk of certain birth defects of the brain, a 56 percent lower risk of cleft lip and a 59 percent lower risk of gastroschisis.
The researchers note that hyperthermia, or excessively high body temperature, has been implicated in the risks of certain birth defects. More studies, they conclude, are needed to confirm whether treating fevers with acetaminophen does in fact prevent some birth defects.
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