Trusted Information for Healthy Pregnancies
medication
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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Antidepressant tied to risk of newborn heart defect
May 4th
Women who use the antidepressant bupropion during early pregnancy may have an increased risk of having a baby with a particular type of heart defect, a new study suggests.
Researchers caution that it is not clear whether the medication, marketed as Wellbutrin, is the cause. And even if it is, they say, the absolute risk of the heart defect would be small -- affecting just 2 out of every 1,000 infants born to women who used bupropion during the first trimester.
But the findings, published in the American Journal of Obstetrics & Gynecology, do add to questions about the risks of using antidepressants during early pregnancy.
Some studies have already linked other antidepressants -- including some of the commonly used selective serotonin reuptake inhibitors (SSRIs) -- to higher-than-average, though small, risks of certain birth defects.
A study last year, for example, found that among nearly half a million Danish children born between 1996 and 2003, the risk of heart defects was elevated among those whose mothers had used SSRIs such as fluoxetine (Prozac), sertraline (Zoloft) and citalopram (Celexa) during early pregnancy.
In this latest study, researchers found that among more than 12,700 U.S. infants born between 1997 and 2004, those whose mothers used bupropion during early pregnancy had more than double the risk of heart defects known as left outflow tract defects, compared with infants whose mothers had not used the drug.
Left outflow defects affect the flow of blood from the heart's left chambers to the rest of the body. In this study, the most common type of this defect was coarctation of the aorta -- a narrowing in the body's main artery that, in children, typically requires surgical repair.
The findings do not mean, however, that depressed women on bupropion should stop taking it if they are planning a pregnancy, according to the researchers.
"I think it's important that women understand that they should not just stop taking their medication," said Dr. Jennita Reefhuis, a senior epidemiologist at the U.S. Centers for Disease Control and Prevention and one of the researchers on the study.
Instead, she told Reuters Health, women should talk with their doctors, ideally when they are planning a pregnancy rather than after they conceive.
The potential risk of birth defects from using antidepressants must be weighed against the risks of a woman stopping her current depression therapy, Reefhuis said.
"This study needs to be replicated before we can say anything conclusive," Reefhuis said, noting that the findings point to an association between bupropion and left outflow defects, but cannot by itself prove cause-and-effect.
If the association is causal, she said, the absolute risk to any one woman would be small. For every 1,000 births, there are an estimated 0.8 cases of left outflow tract heart defects; based on the current findings, that rate would be 2 per 1,000 among women who use bupropion in the first trimester.
Reefhuis also pointed out that with any pregnancy, the overall risk of having a baby with some form of birth defect is 3 percent.
Guidelines released last year by the American Psychiatric Association and the American College of Obstetricians and Gynecologists state that psychotherapy may be an effective alternative to antidepressants for pregnant women with mild to moderate depression.
However, the guidelines say, women with a history of more severe depression, or other major psychiatric disorders, may need to continue with their medication.
Bupropion is also prescribed for smoking cessation, under the brand-name Zyban. In the case of smoking cessation, Reefhuis said, it may be easier for women to find an effective alternative to the drug.
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Mother-daughter pregnancy sickness link found
Apr 30th
Pregnant women are three times more likely to suffer from severe morning sickness if their mothers did, say Norwegian researchers,
Around 2% of women suffer excessive nausea and vomiting in pregnancy - known as hyperemesis gravidarum - which can require hospital treatment.
But a study of 2.3 million births showed a threefold higher rate in those whose mothers had the condition.
Experts said the results could help women better understand their risk.
Hyperemesis is defined as excessive sickness which starts before the 22nd week of pregnancy and in its most serious form it can lead to dehydration and weight loss because women cannot keep food or water down.
It can be extremely debilitating, women can't work, can't look after their families and they need to be admitted to hospital.
It is the most common cause of admission to hospital in early pregnancy and can be a cause of low birth weight and premature birth.
The researchers said that previous studies have attributed the condition to "psychological causes".
They analyzed birth records, which included information on pregnancy complications, from 1967 to 2006.
It found the daughters of women who had the condition during their pregnancy had a 3% risk compared with 1% in those whose mothers did not have it.
But there was no increased risk to the female partners of sons whose mothers had suffered from the illness.
The researchers said although the results suggest a genetic link between mothers and daughters, it is also possible that there are lifestyle or environmental factors shared between mother and daughter that increase the risk.
Dr Catherine Nelson-Piercy, a consultant obstetric physician at Guy's and St Thomas' Foundation Trust in London, said that better understanding of the genetic risks of hyperemesis may help clinicians when counseling women about the risk of recurrence in future pregnancies.
She said many women were undertreated because of the legacy of thalidomide - a drug given for morning sickness in the 1960s which caused birth defects - despite the availability of safe drugs.
"It is safe to take anti-sickness drugs and it's better for the baby and the pregnancy to treat this condition than let the woman get very severely ill and risk complications."
Patrick O'Brien, spokesman for the Royal College of Obstetrics and Gynaecology, said the study added to growing evidence that many conditions in pregnancy, such as diabetes or high blood pressure, were linked to a "genetic predisposition".
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When Health Care Providers Say the Wrong Thing
Apr 14th
With increasing frequency, postpartum women who have taken antidepressants during pregnancy have shared – usually in tears – that while in the hospital for their labor and delivery hospitalization, a health care provider at the hospital said something judgmental about their being on an antidepressant. For example, one woman said that a nurse told her, [...]
Very premature twins do just as well as singletons
Feb 18th
Overall, very premature twins fare just as well as single babies born very early, and they may even face a lower risk of certain complications, new research shows.
But for twin pairs of the same sex but sharply different sizes who are born before 28 weeks, the risks of death and bleeding on the brain are higher than they are for single babies born at the same time, Dr. Jennifer Zeitlin of the Hopital Saint-Vincent de Paul in Paris and her colleagues found.
Premature birth is much more common among twins than singletons, Zeitlin and her team note; while one in every 10 twin pairs is born before 32 weeks' gestation, just one in 100 singletons is born this early. There is evidence that preemie twins do better than singles of the same gestational age, they add.
A full-term pregnancy lasts for 39 weeks, while babies born between 28 and 31 weeks are considered "very preterm." Babies born between 24 and 27 weeks' gestation are "extremely preterm."
To investigate outcomes for very premature and extremely premature twins compared to those of singletons born equally early, Zeitlin and her colleagues looked at births and stillbirths in nine European countries in 2003. Their analysis included 1,254 twins and 3,586 singletons born between 24 and 31 weeks' gestation.
The women carrying twins were less likely to develop high blood pressure during pregnancy than those with singletons, the researchers found: about 8 percent of those carrying twins, compared to about 22 percent of those carrying single babies.
They also found that severe bleeding and restrictions on the growth of the fetus were also less common in twin pregnancies.
Twins' mothers were also more likely to have been given corticosteroids before delivery; these drugs are administered to speed up premature newborns' lung development.
Among the very premature babies, the likelihood of dying in the first few weeks of life was lower for twins, who were also less likely to need oxygen. But once the researchers took factors such as mother's age, pregnancy complications, and infant health problems into account, the difference disappeared.
For the extremely premature infants, however, the researchers calculated that the risk of death or serious bleeding in the brain was about 1.5 times higher for twins than it was for single babies. While about 17 percent of singletons suffered from such bleeding, roughly 24 percent of twins did.
The greater risks were only seen for same-sex twins in which one twin weighed at least 15 percent more than the other twin at birth.
"Why the effects of these twin-specific complications were so much more pronounced for extremely preterm births is an area for further study," the researchers conclude.
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Migraine drugs don’t up birth defect risk: study
Feb 16th
A study in nearly 70,000 pregnant women has found no link between migraine drugs called triptans and the risk of birth defects.
However, the researchers did find a "slight increase" in the risk of excessive bleeding during labor, and the failure of the uterus to contract normally after delivery, for women who used the drugs while pregnant.
Triptans are among the most powerful drugs used for migraine; others include aspirin, Excedrin, and ibuprofen.
While as many as three in 10 women may develop migraines during their childbearing years, women often shy away from using such drugs during pregnancy because of safety concerns, according to study co-author Katerina Nezvalova-Henriksen of the University of Oslo in Norway and her colleagues.
However, the authors of the study in Headache note, untreated migraine may itself carry risks for mother and child; some studies have linked it to pre-eclampsia, a potentially deadly pregnancy complication.
"While it is important to exert caution when using any medications during pregnancy, this study indicates" that pregnant women can either start or continue taking triptans without "any major risk" of miscarriage, premature delivery, or other bad outcomes, the authors conclude.
Nezvalova-Henriksen and her team studied nearly 70,000 women. Two percent, or 1,535, had used sumatriptan (Imitrex), rizatriptan (Maxalt), zolmitriptan (Zomig), or eletriptan (Relpax) in pregnancy.
Less than one percent -- 373 women -- had used the drugs before getting pregnant but not during pregnancy.
The overall birth defect rate, which encompasses everything from large birthmarks to serious heart problems, was the same among women who had taken triptans during pregnancy and those who didn't have migraines: 5 percent. Among those who had used triptans in the past but not during pregnancy, it was slightly higher: 6 percent.
The women who used triptans were also more likely than non-triptan users to take other drugs during pregnancy, including acetaminophen (Tylenol) with codeine and non-steroidal anti-inflammatory drugs such as ibuprofen.
However, the rate of major birth defects - such as serious problems of the limbs or internal organs -- was 3 percent for all three groups. That rate - about one in 33 births - is about what would be expected for all birth defects in the general population.
The researchers did find that women who used triptans in their second or third trimester were more likely to develop a condition called atonic uterus, in which the uterus fails to contract back to its normal size after delivery. This is the leading cause of excessive bleeding after delivery. They were also more likely to lose significant amounts of blood during labor and delivery.
And during pregnancy, they were more likely to suffer from vomiting than women who had never used the drug; they were also more likely to develop pre-eclampsia or eclampsia, and more likely to have deficiencies in the B-vitamin folate.
While many women who suffer migraines will experience improvements in their symptoms after their first trimester, Nezvalova-Henriksen and her team note, those whose symptoms don't improve by then aren't likely to get better.
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Use of Acetaminophen in Pregnancy Associated With Increased Asthma Symptoms in Children
Feb 5th
Children who were exposed to acetaminophen prenatally were more likely to have asthma symptoms at age five in a study of 300 African-American and Dominican Republic children living in New York City. Building on prior research showing an association between both prenatal and postnatal acetaminophen and asthma, this is the first study to demonstrate a direct link between asthma and an ability to detoxify foreign substances in the body. The findings were published this week in the journal Thorax.
The study, conducted by the Columbia Center for Children's Environmental Health at Columbia University's Mailman School of Public Health, found that the relationship was stronger in children with a variant of a gene, glutathione S transferase, involved in detoxification of foreign substances. The variant is common among African-American and Hispanic populations. The results suggest that less efficient detoxification is a mechanism in the association between acetaminophen and asthma.
The researchers assessed the use of analgesics during pregnancy and found that 34 percent of mothers reported acetaminophen use during pregnancy, and 27 percent of children had wheeze, an asthma-related symptom. The children whose mothers had taken acetaminophen were more likely to wheeze, visit the emergency room for respiratory problems, and develop allergy symptoms, compared to those children whose mothers did not take acetaminophen. The risk increased with increasing number of days of prenatal acetaminophen use. The children in this study live in neighborhoods of New York City that have been the hardest hit by the asthma epidemic: Northern Manhattan and the South Bronx.
Acetaminophen use among children in the U.S. has increased substantially since the early 1980s and has become increasingly common among women during pregnancy so that most women in the U.S. take acetaminophen during pregnancy. This increase coincided with a doubling of the prevalence of asthma among children in the country between 1980 and 1995.
"These findings might provide an explanation for some of the increased asthma risk in minority communities and suggest caution in the use of acetaminophen in pregnancy," says Matthew S. Perzanowski, PhD, assistant professor of Environmental Health Sciences at the Mailman School of Public Health.
Reasons for prenatal acetaminophen use vary, but in this study population the observed associations with headaches suggest pain management as likely; however, other host factors that caused mothers to take acetaminophen and also cause asthma may explain their association. While infection is one such potential confounder, the Mailman School researchers found no association between the reported use of antibiotics and acetaminophen, and adjustment for antibiotic use during pregnancy did not affect the results.
According to the researchers, the prevalence of current wheeze diminished as the children aged, from 40 percent at age one year to 25 percent, 17 percent and 27 percent at ages two, three, and five, respectively. However, the association between prenatal acetaminophen exposure and current wheeze strengthened as the children aged.
The Columbia Center for Children's Environmental Health study adjusted relative risks for sex, race/ethnicity, birth order, maternal asthma, maternal hardship, exposure to environmental tobacco smoke, antibiotic use and postnatal acetaminophen use.
In a similar study conducted in the UK, the frequency of acetaminophen use during pregnancy and the magnitude of association in the UK study were similar to that in New York City.
Source
Acupuncture Found Effective Against Depression During Pregnancy
Feb 4th
In a study to be presented February 4 at the Society for Maternal-Fetal Medicine's (SMFM) annual meeting, The Pregnancy Meeting ™, in Chicago, researchers will unveil findings that show that acupuncture may be an effective treatment for depression during pregnancy.
"Depression during pregnancy is an issue of concern because it has negative effects on both the mother and the baby as well as the rest of the family," said Dr. Schnyer, one of the study's authors.
About 10% of pregnant women meet criteria for major depression and almost 20% have increased symptoms of depression during pregnancy. The rates of depression in pregnant women are comparable to rates seen among similarly aged non-pregnant women and among women during the postpartum period, but there are far fewer treatment studies of depression during pregnancy than during the postpartum period.
Dealing with depression is difficult for pregnant women because the use of anti-depressants poses concerns to the developing fetus and women are reluctant to take medications during pregnancy.
In the study, an evaluator-blinded randomized trial, 150 participants who met the Diagnostic & Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for Major Depressive Disorder were randomized to receive either acupuncture specific for depression (SPEC, n=52) or one of two active controls: control acupuncture (CTRL, n=49) or massage (MSSG, n=49). Treatments lasted eight weeks (12 sessions). Junior acupuncturists masked to treatment assignment needled participants at points prescribed by senior acupuncturists. Massage therapists and patients were not blinded. The primary outcome was the Hamilton Rating Scale for Depression, administered by blinded raters at baseline and after four and eight weeks of treatment. Data were analyzed using mixed effects models and by intent-to-treat.
The results showed that the women who received SPEC experienced a significantly greater decrease in depression severity compared to the combined controls or CTRL acupuncture alone. They also had a higher response rate (63.0%) than the combined controls or CTRL acupuncture alone. Symptom reduction and response rates did not differ significantly between controls (CTRL 37.5% and MSSG 50.0%). Mild and transient side effects were reported by 43/150 participants (4 in MSSG; 19 in CTRL, 20 in SPEC). Significantly fewer participants reported side-effects in MSSG than the two acupuncture groups.
"The results of our study show that the acupuncture protocol we tested could be a viable treatment option for depression during pregnancy" said Dr. Schnyer.
Source
Drugs for depression, anxiety tied to preterm birth
Jan 21st
Pregnant women who take certain drugs for depression or anxiety may have heightened risks of preterm delivery or other birth complications, according to a new study.
Researchers found that among nearly 3,000 women who gave birth in Washington State, those who started taking antidepressants known as selective serotonin reuptake inhibitors (SSRIs) in the second or third trimester had a higher risk of preterm birth.
Compared with their counterparts not on the medications, these women were nearly five times more likely to deliver prematurely.
The same risk was not seen, however, among women who started on an SSRI before pregnancy or during the first trimester. SSRIs include drugs like sertraline (Zoloft), paroxetine (Paxil) and fluoxetine (Prozac).
The researchers also found a higher risk of preterm delivery among women who took anti-anxiety drugs known as benzodiazepines, regardless of when they began treatment.
Those drugs, which include medications like lorazepam (Ativan) and alprazolam (Xanax), were linked to higher risks of other complications as well - including low birth weight, newborn respiratory distress and a low Apgar score, a standard measure of newborn health.
The findings of the study are published in the American Journal of Obstetrics & Gynecology.
Exactly what the study means for women on SSRIs or benzodiazepines is not entirely clear. A major limitation is that it could not estimate the benefits of treatment, lead researcher Dr. Ronit Calderon-Margalit, of the Hebrew University-Hadassah School of Public Health in Jerusalem, noted in an email to Reuters Health.
Any risks of using the medications during pregnancy need to be balanced against the risks of leaving depression and anxiety disorders untreated.
"It is very important to have other studies of the risks associated with (these) drugs, but also of benefits associated with treating mothers," said Calderon-Margalit, who was at the University of Washington in Seattle at the time of the study.
In addition, SSRIs did not appear to present equal risks for all women. Calderon-Margalit described the antidepressant findings as "mostly reassuring" for women who start the drugs before pregnancy or in the first trimester -- as most SSRI users in the study had.
The study included 2,793 pregnant women, 11 percent of whom used a psychiatric medication during pregnancy. Of these, 138 were on an SSRI, while 85 used a benzodiazepine.
Among women who were not on any medication, 9 percent gave birth prematurely, versus nearly half of women on benzodiazepines.
Meanwhile, 14 percent of women on SSRIs had a preterm birth, but the elevated risk turned out to be concentrated among those who started an antidepressant after the first trimester. Of those 21 women, 16 delivered prematurely.
Several other birth complications, often related to preterm birth, were also higher-than-average among women on benzodiazepines.
Seventeen percent of their newborns suffered respiratory distress syndrome and one-third ended up in the neonatal intensive care unit. Those figures were 3 percent and 6 percent, respectively, among newborns whose mothers had not used psychiatric medications during pregnancy.
Calderon-Margalit pointed out that most women on benzodiazepines used lorazepam (Ativan), so it is possible that the risks are associated mainly with that drug. However, further research is needed to determine whether any particular medications carry particular risks.
Source
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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