Day: 05/31/2013

FDA denies approval to Endo’s testosterone drug again

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The Food and Drug Administration has for the third time refused approval to Endo Health Solutions Inc’s injectable testosterone drug Aveed, pressing for a still better plan to manage the risks associated with the drug.

The denial comes as no surprise after an advisory panel to the FDA overwhelmingly agreed in April that Endo’s proposed plan for managing the risks associated with the drug was insufficient.

Testosterone, a hormone produced in the testicles, is responsible for maintaining muscle bulk, bone growth and sexual function. Lack of testosterone can lead to loss of libido, depression, decreased muscle mass and fatigue.

Aveed is made of testosterone and castor oil and the FDA has previously expressed concern of a risk that the oil could cause blockages in blood vessels in the lungs.

Lack of a suitable strategy to address these issues had led the FDA to refuse Aveed’s marketing application the last two times.

On Thursday, Endo said the agency wants it to include a medication guide and other some additional elements to its risk mitigation strategy to ensure the safe use of the drug and to avoid severe complications related to post-injection reactions, the drugmaker said on Thursday.

It, however, did not ask Endo to perform an additional clinical study.

Endo added that it plans to respond to the FDA by the end of the third quarter of this year.

Endo’s shares closed at $35.94 on Thursday on the Nasdaq and declined only marginally to $35.91 after market close.

 

Source: yahoo news

 

C-section OK for pregnant woman in El Salvador.

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El Salvador’s government gave permission Thursday for doctors to perform a premature delivery for a seriously ill woman whose pregnancy attorneys say is putting her life at risk.

The case of the 22-year-old woman known only as Beatriz has drawn international attention as she sought to end the pregnancy in a country with some of the strictest abortion laws in Latin America.

The move by Health Minister Maria Isabel Rodriguez came a day after the Supreme Court ruled that Beatriz, who is six months pregnant, could not have an abortion even though she suffers from lupus and kidney failure. Ultrasound images indicate that her fetus is developing with only a brain stem and is given no chance of surviving.

Because the pregnancy is 26 weeks along, abortion laws are no longer at play, according to women’s groups who have supported her petition. Rather, the health ministry can determine what’s most medically sound for the mother versus the unborn baby.

“She is in the hands of top-notch doctors,” Rodriguez said. “The medical team at the Maternity Hospital is ready to act immediately at the slightest sign of danger.”

The Central American country’s laws prohibit all abortions, even when a woman’s health is at risk, and the woman and any doctor who terminated her pregnancy would face arrest and criminal charges.

The Health Department hasn’t given a day or time for when Beatriz will deliver the baby by cesarean section, said Morena Herrera, a member of the Feminist Collective for Local Development, an organization that has been supporting Beatriz.

“She is going through all the medical exams to be ready for surgery,” Herrera said.

The Supreme Court said physical and psychological exams done on the woman by the government-run Institute of Legal Medicine found that her diseases are under control and she can continue the pregnancy.

The judges voted 4-to-1 to reject the appeal by the woman’s lawyers, who argued that continuing with the pregnancy put her life at risk.

The ruling brought widespread criticism, including a statement by Amnesty International calling the court decision “cruel and callous” and “a potential death sentence for Beatriz.”

Abortion opponents said the case is being used to press for legalized abortion in El Salvador.

 

Source: yahoo news

 

A Radical Self-care Conspiracy to Transform Your Life.

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SELF-CARE

Let us advance on Chaos and the Dark. ~Ralph Waldo Emerson

Each of us views the world through lenses of our choice, and I believe that a closer look at superficial symptoms can reveal a profound underlying root cause. Often people feel broken or lost among an overwhelming amount of inputs.

When this occurs, I like to get to the root cause of suffering, which can often be lifted with a renewal of commitment to self-care. Did you know that the word “radical” actually means root? Equally as interesting is the meaning of the word “conspire”: to breathe together.

Daily, we are invited to participate in stories with others, where sometimes all we can do is breathe together. Is it possible to take a closer look at where we do have power to shape our own stories within a larger community? Recently a loved one sent me the above photograph of a rose bush, which I believe illustrates my point. A single yellow rose, with its own distinct fragrance, stands out among the red roses who expected it to be red also. They are all rooted in the same source and get light from the same source, but one flower has processed the sunlight through very different lenses.

What better way to further illustrate self-care than with a fable by the Brothers Grimm entitled The Handless Maiden?

A father has fallen into poverty and makes a deal with a shady character: Severing his daughter’s hands in exchange for endless material wealth.

After the maiden’s hands are severed, she relegates herself to the forest, eating fruit from the trees like a giraffe. When a charming land baron finds her grazing in his pear orchard, he has hands of silver fashioned for her. The two fall in love and have a child together.

But the shady character begins to stalk the maiden once again, so she has her child lashed to her back and escapes to the forest. As she sits near a stream to attempt to nurse her baby, the baby slips into the stream. The maiden desperately thrusts her silver hands into the water, but as she brings her arms up out of the water, her silver hands have been replaced with real flesh and fingers, with her child clutched inside them. 

She realizes her power for renewal lies in the water, and that in caring for her baby she has ultimately cared for herself.

I love this story for its vivid imagery and creepiness, but also for the message of shaping our own stories despite the overwhelming pressures and inputs we must process. Each of us can see ourselves as the yellow rose from the photograph, breathing together with the rest while also voicing the song that only we can sing.

Source: Purpose Fairy

Lucentis® receives positive opinion for patients with myopic choroidal neovascularization showing vision gains with only two injections.

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  • Lucentis recommended for approval in EU to treat patients with visual impairment due to choroidal neovascularization secondary to pathologic myopia
     
  • Lucentis superior to current standard of care and improves mean visual acuity by around 14 letters at one year with a median of a total of two injections
     
  • Untreated, 90 % of patients with myopic choroidal neovascularization suffer severe visual loss

 

Novartis has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Lucentis® (ranibizumab) to treat patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (myopic CNV).

 

CNV is the most common vision-threatening complication of high myopia[1]. Myopic CNV usually affects patients younger than 50 years old so any associated vision loss can have not only a significant impact on their quality of life but also on their productivity and to society[2]. In patients with untreated myopic CNV the long-term prognosis is poor with approximately 90% of affected patients developing severe vision loss after five years[3].

 

“Lucentis has already transformed the management of wet AMD, and we are very hopeful that if Lucentis receives approval in a fourth major ocular indication that patients with myopic CNV will benefit from this medicine,” said Tim Wright, Global Head of Development, Novartis Pharmaceuticals. “Currently, all we hope to do for these patients is to stabilize vision and prevent further vision loss, so a treatment with the long-term safety profile of Lucentis that actually improves and maintains vision with just a few injections would be of great benefit.”

 

The submission was supported by data from the Novartis-sponsored clinical trial, RADIANCE, that showed Lucentis provides superior improvement in visual acuity compared with the current licensed standard of care, Visudyne® (verteporfin PDT), in patients with myopic CNV. These new data showed around 40% of Lucentis treated patients compared with 15% of Visudyne treated patients gained 15 or more letters of visual acuity at month three[4]. Mean visual acuity gains of approximately 14 letters at one year were demonstrated with Lucentis; this was with a median of 2.0 injections.

 

In this pivotal Phase III study patients were randomized to one of three treatment arms: Lucentis treatment based on visual acuity stability (group 1) or disease activity (group 2); or Visudyne treatment (group 3). Subjects randomized to Visudyne could be given Lucentis after three months based on persistent disease activity. The primary endpoint was Lucentis superiority to Visudyne based on the mean visual acuity change from baseline to month three. Patients were followed for twelve months.

 

Both the Lucentis treatment groups were statistically superior (p<0.00001) to the Visudyne treatment group. Mean letter gains at month three from baseline in the two Lucentis groups (groups 1 and 2) were 12.1 and 12.5 letters, respectively, compared to a 1.4 letter gain in the Visudyne treatment arm (group 3). At twelve months, the mean letter gains from baseline were 13.8 (group 1), 14.4 (group 2) and 9.3 (group 3).

 

The safety profile of Lucentis was consistent with that observed in other studies as well as real-world experience and no new ocular/non-ocular safety risks were identified. The most common adverse events occurring in more than ten percent of patients, at twelve months, were conjunctival hemorrhage (ocular) and nasopharyngitis (non-ocular).

 

About Lucentis® (ranibizumab)

Lucentis is a humanized therapeutic antibody fragment designed to block all biologically active forms of vascular endothelial cell growth factor-A (VEGF-A). Increased levels of VEGF-A are seen in wet AMD and other ocular diseases such as diabetic macular edema (DME) and retinal vein occlusion (RVO). Lucentis was specifically designed for the eye, minimizing systemic exposure.

 

Lucentis is licensed for the treatment of wet AMD in more than 100 countries, in more than 90 countries for the treatment of visual impairment due to DME and in 90 countries for visual impairment due to macular edema secondary to RVO, including both branch- and central-RVO. In many countries, including those in Europe, Lucentis has an individualized treatment regimen with the goal of maximizing visual outcomes while minimizing under- or over-treating patients.

 

Lucentis has a well-established safety profile supported by 43 extensive sponsored clinical studies and real-world experience. Its safety profile has been well established in a clinical development program that enrolled more than 12,500 patients across indications and there is more than 1.7 million patient-treatment years of exposure since its launch in the United States in 2006.

 

Lucentis was developed by Genentech and Novartis. Genentech has the commercial rights to Lucentis in the United States. Novartis has exclusive rights in the rest of the world. Lucentis is a registered trademark of Genentech Inc.

 

Novartis sponsors the eXcellence in Ophthalmology Vision Award (XOVA). XOVA is an annual award launched in 2010 that provides funding to non-profit initiatives and projects that will have a positive impact on improving the quality of eye care and make a significant impact in addressing unmet needs in the fields of ophthalmology and optometry.

 

Source: Novartis Newsletter

Metreleptin improved metabolic parameters in children with lipodystrophy .

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Positive results from an NIH-supported analysis indicate an investigational recombinant analogue of human leptin has potential as a therapy for pediatric lipodystrophy, according to data presented at the 2013 Pediatric Academic Societies Annual Meeting.

The literature has established that lipodystrophy is known to cause metabolic abnormalities (ie, hypertriglyceridemia, insulin resistance, diabetes andsteatohepatitis), which tend to become severe through childhood and adolescence, and may be resistant to current treatment options.

Rebecca Brown, MD, assistant clinical investigator of the diabetes, endocrinology and obesity branch at the National Institute of Diabetes and Digestive and Kidney Diseases, and colleagues included pediatric patients in an ongoing, open-label study at the NIH (2000 to present).

According to abstract data, patients included in the study (n=39; nine male and 30 female; mean age, 11.9 years) had four subtypes of the disease: congenital generalized lipodystrophy (n=26, 67%), acquired generalized lipodystrophy (n=9, 23%), familial partial lipodystrophy (n=2, 5%), and acquired partial lipodystrophy (n=2, 5%).

On average, the researchers administered metreleptin 4.4 mg (Bristol-Myers Squibb and AstraZeneca) subcutaneously once or twice daily for a mean duration of 3.9 years.

Data indicate that baseline HbA1c (9.8%) decreased significantly to 7.7% after 12 months (–2.3; 95% CI, –3.2 to –1.4) in adolescent patients aged 12 to 18 years.

Triglycerides were notably high in the same group at baseline (1,378 mg/dL), but improved significantly to 385 mg/dL after 12 months (–44; 95% CI, –73 to –15), according to data.

Both age groups displayed significantly elevated mean alanine aminotransferase (ALT; ≤12 years: 193 U/L; adolescents: 105 U/L) and aspartate aminotransferase (AST; ≤12 years: 119 U/L; adolescents: 87 U/L) at baseline. However, ALT (≤12 years: 155 U/L; adolescents: 59 U/L) and AST (≤12 years: 90 U/L; adolescents: 57 U/L) decreased after metreleptin therapy, according to data.

“Metabolic disorders resulting from lipodystrophy can develop in childhood and adolescence and are exacerbated over time,” Brown said in a press release. “This new analysis supports the continued study of investigational metreleptin as a potential treatment option for pediatric patients with lipodystrophy.”

Overall, metreleptin was well tolerated, and the most common adverse events reported were decreased weight (n=3, 7.7%) and hypoglycemia (n=3, 7.7%), followed by fatigue (n=2, 5.1%) and nausea (n=2, 5.1%), the researchers wrote.

According to the press release, metreleptin has acquired orphan designation from the FDA, and the European Medicines Agency is evaluating the agent.

  • o    Source: Endocrine Today

 

Researchers assess multiple vitamin D doses in healthy breast-fed infants.

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Researchers in Canada suggest that vitamin D supplementation of 1,600 IU per day increased plasma 25-hydroxyvitamin D concentrations to at least 75 nmol/L among 97.5% of infants aged 3 months. However, this dosage also increased concentrations associated with hypocalcemia, according to data.

The literature has established that vitamin D supplementation for infants is required to support healthy bone mineral accretion. However, conflicting recommendations for this patient population have led to further research.

“We have generated strong support using evidence-based dose response studies that the 400 IU dosage is quite satisfactory and that this is recommended now by the Institute of Medicine, Health Canada, Canadian Pediatric Society and the American Academy of Pediatrics,” researcher Hope Weiler, RD, PhD, of the School of Dietetics and Human Nutrition at McGill University in Quebec, said during a media telebriefing. “We also know that the higher dose recommended by the Canadian Pediatrics Society was well received by our infants and did generate a nice response in 25-hydroxyvitamin D, and the upper limits of 1,000 IU and 1,200 IU would be suitable as safety markers across the first year of life.”

According to data from a double blind, randomized study published in JAMA, Weiler and colleagues investigated the efficacy of various dosages of vitamin D supplements in supporting plasma 25-(OH)D concentrations in healthy, breast-fed infants (n=132) aged 1 month. The patients were randomly assigned to oral cholecalciferol (vitamin D3) supplements of 400 IU per day (n=39), 800 IU per day (n=39), 1,200 IU per day (n=38) or 1,600 IU per day (n=16), and they were followed for 11 months.

According to 3-month data, 55% (95% CI, 38-72) of infants in the 400-IU group demonstrated a 25-(OH)D concentration of at least 75 nmol/L vs. 81% (95% CI, 65-91) in the 800-IU group, 92% (95% CI, 77-98) in the 1,200-IU group and 100% in the 1,600-IU group. Due to elevations in 25-(OH)D concentrations, the 1,600 IU dosage was discontinued, researchers wrote. Moreover, the concentration did not continue in 97.5% of the infants at age 12 months in any of the groups.

Further data indicate that all dosages established 25-(OH)D concentrations of at least 50 nmol/L among 97% (95% CI, 94-100) of the infants at 3 months. This continued in 98% (95% CI, 94-100) at 12 months, the researchers wrote.

“Future studies should be larger and, hopefully, be able to detect early, as well as [determine], long-term benefits to bone. We may also consider other health benefits such as the immune system. Our future studies should consider other populations,” Weiler said. “We should also consider those at higher risk for deficiency, whether it’s due to geographic location where a mother’s exposure to sunshine is limited or the infant is born with vitamin D deficiency.”

In an accompanying editorial, Steven A. Abrams, MD, of the department of pediatrics at the US Department of Agriculture/Agricultural Research Service Children’s Nutrition Research Center at Baylor College of Medicine and Texas Children’s Hospital in Houston, said the study did not answer the question of what the target should be for plasma 25-(OH)D concentrations.

“Of importance, higher vitamin D dosages in this study did not lead to improved bone outcomes as reflected by DXA results for bone mineral content,” Abrams wrote.

He suggested that higher vitamin D intake and target plasma 25-(OH)D concentrations should be tested in clinical trials with markedly defined outcomes and precise safety monitoring.

 

Weiler H. JAMA. Theme Issue on Child Health: New research on the optimal dosing and possible adverse effects of different levels of vitamin D supplementation, important for bone health, for infants. Presented at: the JAMA Network 2013 Media Briefing; April 30, 2013; New York.

Disclosure: Abrams reports payment for lectures’/speakers’ bureaus from Mead-Johnson Nutrition and Abbott Nutrition and grants to his institution from Mead-Johnson Nutrition. Gallo reports travel support from CIHR Human Development Child and Youth Health and the American Society for Bone and Mineral Research. Sharma reports consulting fees for analyses prepared for Rodd and Weiler. Jones reports being cofounder and scientific advisory board member for Cytochroma Inc., and for receiving payment for speakers’ bureaus from Genzyme/Sanofi.

 

 

PERSPECTIVE

 

  • I  think it’s a helpful study in terms of the fact that they had different groups of newborn children treated with vitamin D with 400 IU being the recommended dose up to 12 months according to the Institute of Medicine and Endocrine Society guidelines. It was a well-designed study and relevant because vitamin D is a very hot topic right now due to the deficiencies in children and adults.

I agree with the editorial. This group of patients was a mostly white group with relatively high socioeconomic status. In the group that was administered 400 IU per day, researchers found that those infants reached 25(OH)D level of at least 20 ng/mL. That is a big debate. The IOM thinks 25(OH)D levels of 20 ng/mL are adequate for most, and I think a lot of endocrinologists and the Endocrine Society says most people need a level of 30 ng/mL.

This study shows that infants who were administered up to 400 IU per day reached a level of at least 20 ng/mL by 3 months. The whole group did not attain the level of 30 ng/mL, which again is what some endocrinologists think is an optimal level. To achieve a level of 30 ng/mL, perhaps 400 IU is not enough per day for some infants (especially those with darker skin pigmentation or at higher risk for deficiencies).

In addition to looking at the levels or how much vitamin D is needed to achieve a level of 20 ng/mL or 30 ng/mL, they also looked at the bone mineral content but found no significant difference in the groups. I think the editorial comment summed up this point. In treating infants with higher doses of vitamin D corresponding to higher serum levels above 30 ng/mL; does that confer other benefits? There are many early studies now looking at the relationship between vitamin D and asthma, food allergies, incidence of type 1 diabetes and autoimmune disease.

The important point Abrams raises is that we need more long-term studies to see if there is a skeletal benefit in terms of having a higher vitamin D level which would correspond to having a higher dose of vitamin D administered.

  • Dominique Noё Long, MD
  • Instructor of pediatric endocrinology
    The Johns Hopkins Children’s Center
    Baltimore, Md.

PERSPECTIVE

 

  • The strengths and usefulness of the study are the quantification of serum 25-OH vitamin D levels with various doses of vitamin D supplementation. The currently recommended dose of vitamin D, 400 IU daily, was chosen because historically this dose has proven to prevent rickets, which as pediatric endocrinologists, is our main objective. Therefore this study helps provide information in the ongoing debate regarding the optimal serum level of 25(OH) D. Interestingly, all doses of cholecalciferol increased serum levels of 25(OH) D to >50 nmol/L. Higher doses of cholecalciferol correlated with higher levels of 25(OH) D, however no group sustained >97.5% of infants to vitamin D levels >75 nmol/L. No one truly knows the ideal serum level of vitamin D, but this study suggests that >50 nmol/L was sufficient in this patient population. This study also provides information on the safety of higher doses of vitamin D supplementation. It may be harder to extrapolate in the darker-skin pigmented population who may need more vs. the white population. It’s just another piece to the puzzle of the debate on vitamin D.
  • Janet Crane, MD
  • Clinical research fellow in pediatric endocrinology
    The Johns Hopkins Children’s Center
    Baltimore, Md.

 

 

Iodine deficiencies during pregnancy linked to lower IQ in offspring.

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Iodine deficiencies during pregnancy may have negative neurocognitive outcomes among offspring, according to findings by researchers in the United Kingdom that were published in The Lancet.

“Pregnant women and those planning a pregnancy should ensure adequate iodine intake; good dietary sources are milk, dairy products and fish. Women who avoid these foods and are seeking alternative iodine sources can consult the iodine fact sheet that we have developed, which is available on the websites of the University of Surrey and the British Dietetic Association. Kelp supplements should be avoided, as they may have excessive levels of iodine,” Sarah C. Bath, PhD, RD, of the department of nutritional sciences at the University of Surrey, said in a press release.

Bath and colleagues analyzed stored samples of urinary iodine concentrations from 1,040 first-trimester pregnant women, measures of IQ from the offspring aged 8 years and reading ability at age 9 years. The mother-child pairs were collected from the Avon Longitudinal Study of Parents and Children (ALSPAC).

The researchers defined mild-to-moderate iodine deficiency as a median urinary iodine concentration of 91.1 mcg/L (interquartile range [IQR], 53.8-143; iodine-to-creatinine ratio of 110 mcg/g; IQR, 74-170).

After adjusting for 21 socioeconomic, parental and child factors as confounders, data indicated that children of women with an iodine-to-creatinine ratio of less than 150 mcg/g were more likely to have scores in the lowest quartile for verbal IQ (OR=1.58; 95% CI, 1.09-2.3), reading accuracy (OR=1.69; 95% CI, 1.15-2.49) and reading comprehension (OR=1.54; 95% CI, 1.06-2.23) vs. those of mothers with ratios of at least 150 mcg/g. Furthermore, scores continued to dwindle when the less than 150-mcg/g group was subdivided, researchers wrote.

In an accompanying commentary, Alex Stagnaro-Green, MD, MHPE,professor of medicine and obstetrics and gynecology at the George Washington University School of Medicine and Health Sciences, andElizabeth N. Pearce, MD, associate professor of medicine at Boston University School of Medicine, wrote that this study, along with previous research, represents a call-to-action because of the documented link between iodine deficiency and poor neurocognitive outcomes.

 “Absence of a public health policy in the face of clear documentation of moderate iodine deficiency and strong evidence of its deleterious effect on the neurodevelopmentof children is ill advised,” they wrote. “Nor should unmonitored and adventitious dietary iodine sources continue to be relied on.”

Source: Endocrine Today

Effect of inadequate iodine status in UK pregnant women on cognitive outcomes in their children: results from the Avon Longitudinal Study of Parents and Children (ALSPAC)

Summary

Background

As a component of thyroid hormones, iodine is essential for fetal brain development. Although the UK has long been considered iodine replete, increasing evidence suggests that it might now be mildly iodine deficient. We assessed whether mild iodine deficiency during early pregnancy was associated with an adverse effect on child cognitive development.

Methods

We analysed mother—child pairs from the Avon Longitudinal Study of Parents and Children (ALSPAC) cohort by measuring urinary iodine concentration (and creatinine to correct for urine volume) in stored samples from 1040 first-trimester pregnant women. We selected women on the basis of a singleton pregnancy and availability of both a urine sample from the first trimester (defined as ≤13 weeks’ gestation; median 10 weeks [IQR 9—12]) and a measure of intelligence quotient (IQ) in the offspring at age 8 years. Women’s results for iodine-to-creatinine ratio were dichotomised to less than 150 μg/g or 150 μg/g or more on the basis of WHO criteria for iodine deficiency or sufficiency in pregnancy. We assessed the association between maternal iodine status and child IQ at age 8 years and reading ability at age 9 years. We included 21 socioeconomic, parental, and child factors as confounders.

Findings

The group was classified as having mild-to-moderate iodine deficiency on the basis of a median urinary iodine concentration of 91·1 μg/L (IQR 53·8—143; iodine-to-creatinine ratio 110 μg/g, IQR 74—170). After adjustment for confounders, children of women with an iodine-to-creatinine ratio of less than 150 μg/g were more likely to have scores in the lowest quartile for verbal IQ (odds ratio 1·58, 95% CI 1·09—2·30; p=0·02), reading accuracy (1·69, 1·15—2·49; p=0·007), and reading comprehension (1·54, 1·06—2·23; p=0·02) than were those of mothers with ratios of 150 μg/g or more. When the less than 150 μg/g group was subdivided, scores worsened ongoing from 150 μg/g or more, to 50—150 μg/g, to less than 50 μg/g.

Interpretation

Our results show the importance of adequate iodine status during early gestation and emphasise the risk that iodine deficiency can pose to the developing infant, even in a country classified as only mildly iodine deficient. Iodine deficiency in pregnant women in the UK should be treated as an important public health issue that needs attention.

Source: Lancet

 

 

Teenage pregnancy increased risk for obesity .

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 According to data from the National Health and Nutrition Examination Survey, researchers have determined that teenage mothers are more likely to develop obesity later in life.

“For the first time, we’ve identified our youngest moms as a high-risk group for obesity, which we know to be one of the most debilitating, long-term health issues we face,”Tammy Chang, MD, MPH, MS, clinical lecturer at the University of Michigan Medical School and a Robert Wood Johnson Foundation Clinical Scholar, said in a press release.

Chang and colleagues used the 2001-2010NHANES to investigate associations between overweight and obesity and teenage births among women aged 20 to 59 years. The patients were included if they had at least one live birth, were not pregnant at the time of the survey or recently pregnant (unweighted, n=5,220; weighted, n=48.4 million), researchers wrote.

After performing bivariate analyses, the researchers found that women with a teen birth were significantly more likely to become overweight (RR=1.61; 95% CI, 1.37-1.90) or obese (RR=1.84; 1.56-2.16) compared with women who did not have a teen birth. Adjusted data indicate women with a teen birth continued to be more susceptible for becoming overweight (aRR=1.33; 95% CI, 1.10-1.62) or obese (aRR=1.32, 95% CI, 1.09-1.61) compared with women without a teen birth, they wrote.

“We know that teen pregnancy is tied to certain immediate risks, such as babies having low birth weight and mothers struggling to complete high school — and now we know that it is also associated with poor long-term health outcomes,” Chang said. “Obesity is a prevalent, expensive health problem with detrimental health consequences and it’s difficult to reverse, which is why it’s incredibly important to identify at-risk groups early so that we can intervene.”

The researchers suggest further studies on modifiable physiologic and sociomedical reasons behind early pregnancy and subsequent risk forobesity.

 

PERSPECTIVE

 

  • This study is unique in that it  investigates whether teen pregnancy could be a risk factor for obesity later in life. The researchers looked at data on about 5200  women aged 20 to 59.

The investigators  sought to examine the difference in the prevalence of obesity or overweight status in women who gave birth between ages 13 and 19 years  vs. those who gave birth at age 20 or later. They found that women who gave birth during their teen years were 32% more likely to be obese compared to women who gave birth at or after age 20

Clearly, this study establishes teen pregnancy as a risk factor for obesity later in life. However, we’ve  to recognize that this is an association study and it doesn’t necessarily suggest cause-and-effect link between teen pregnancy and development of obesity in later life.

The findings are not necessarily surprising because there are common sociographic factors that predispose patients to teen pregnancy as well as obesity (i.e., lower socioeconomic status, school and home environments with limited access to healthy  to healthy foods, limited places to exercise, poor understanding of health in general, or poor access to health care).

The researchers also point out that avoiding teen pregnancy might be one of the ways we can  decrease development of  obesity in adults. We often think about teen pregnancy and short-term consequences such as interruption in  education of the mother and poor access to health care and adequate resourcesbut this study  highlights a long term health risk teen pregnancy may have has on these  teens later in life.

 

Source: Endocrine Today

 

 

Early maternal smoking linked to daughters’ risk for obesity, diabetes.

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Women who smoke cigarettes in the early stages of pregnancy could put their daughters at risk for developing gestational diabetes and obesity in adulthood, according to recent study data published in Diabetologia.

Previous data have suggested that smokingis a preventable environmental exposure that may lead to various adverse outcomes among children that continue through adulthood. In this study, researchers from Sweden and the NIH collected data from the Medical Birth Register of Sweden for women born in 1982 or later who also gave birth to at least one child (n=80,189).

The women were categorized into three groups: non-smokers, moderate smokers (1-9 cigarettes per day) and heavy smokers (>9 cigarettes per day). Available data on daughters demonstrated that 291 developed gestational diabetes, 280 developed non-gestational diabetes and 7,300 developed obesity.

Upon further analysis, researchers determined that the adjusted risk forgestational diabetes was increased among women who were moderately (OR=1.62; 95% CI, 1.24-2.13) and heavily (OR=1.52; 95% CI, 1.12-2.06) exposed to cigarette smoke. Regarding obesity, these risks also increased among women who were moderately (OR=1.36; 95% CI, 1.28-1.44) and heavily (OR=1.58; 95% CI, 1.48-1.68) exposed, according to data.

Conversely, data indicated a reduced risk for non-gestational diabetes among the offspring of heavy smokers (OR=0.66; 95% CI, 0.45-0.96), the researchers wrote.

“Although short-term detrimental effects of smoking on the individual and her offspring are well known, such associations might extend into adulthood, making the incentive stronger for undertaking preventable measures, particularly as numbers in some countries point to an increase in daily smoking among young women,” the researchers concluded.

Source: Endocrine Today

FDA Warns Against Prolonged Use of Magnesium Sulfate to Stop Preterm Labor.

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The FDA is changing the label of magnesium sulfate to warn against its use for more than 5 to 7 days to stop preterm labor. Long-term use can lead to hypocalcemia, osteopenia, and fractures in the infant. In addition, the drug’s pregnancy category is being changed from A to D, indicating “positive evidence of human fetal risk.”

The FDA reemphasizes that magnesium sulfate is not approved to stop preterm labor. It is unknown whether a shorter treatment duration would result in harm to the fetus.

The warning comes after the FDA reviewed epidemiologic data and 18 cases of skeletal abnormalities in infants exposed to magnesium sulfate in utero (average duration of exposure, 10 weeks). The epidemiologic data indicate that laboratory results normalize within days of birth, but long-term clinical effects on bone health aren’t known.

Asked to comment, Allison Bryant of Journal Watch Women’s Healthwrote: “The use of magnesium sulfate as a tocolytic persists in many institutions. In addition, data suggesting its effectiveness in providing neuroprotection for fetuses exposed in utero and born at early gestational ages have led to a resurgence in use. However, there are no data suggesting value to using magnesium sulfate for tocolysis for longer than 48 hours, for neuroprotection beyond when delivery is felt to be imminent, or for seizure prophylaxis in the setting of preeclampsia beyond 24 hours postpartum. Therefore, this FDA warning is unlikely to greatly alter current clinical practice.”

Source: FDA