• More Evidence Linking NSAIDs to Heart Failure Hospitalization
• Heavy Hydrogen (Deuterium) Makes Drugs Last Longer in the Body
• Benefits of Low Sodium Intake Still up in the Air
• Children who've rReceived certain Alternative Therapies appear less likely to get Flu Shot
• Teen Birth Rate Hits All-Time Low
• Screening Colonoscopy Provides Little Benefit to Adults Aged 70–79
• Clinicians Less Likely to Counsel Low-Income Patients About Weight Loss
• DEA: Fewer Opioids to Be Manufactured Next Year
• OnabotulinumtoxinA vs. Sacral Neuromodulation for Urgency Incontinence: No Clear Winner
• FDA Warns Against Use of Homeopathic Teething Tablets and Gels
• Elephant Tranquilizer Implicated in Recent Overdose Deaths
• Taiwan Active Pharmaceutical Ingredient Plant Cited for Filthy, Smelly Rooms and
Uncleaned Equipment
• Early Infant Self-Feeding Does Not Increase Choking Risk
• Early Introduction of Egg and Peanut associated with Reduced Allergy Risks
• Measles Eradicated in the Americas
• Report: First Baby Born with DNA from 3 People
• Genetically Modified Enzymes used in Household Products seen as "Potent Allergens"
• U.N. Tackles Antimicrobial Resistance
• Cases of Acute Flaccid Myelitis Up Again in U.S.
• Morning Sickness associated with Reduced Risk for Pregnancy Loss
• Wearable Fitness Trackers might not Aid in Weight Loss
• FDA Clears Balloon Device to Treat Eustachian Tube Dysfunction
More Evidence Linking NSAIDs to Heart Failure Hospitalization
By Kelly Young
Individual nonsteroidal anti-inflammatory drugs (NSAIDs) are associated with increased risk for heart failure hospitalization, according to a large study in The BMJ.
Using electronic health databases from four European countries, researchers identified 7.7 million adults who started taking prescription NSAIDs in 2000–2010. The 92,000 patients who were admitted for heart failure were matched to controls without heart failure admissions.
Current use of any NSAID was associated with a 19% higher risk for heart failure hospitalization. The following individual, FDA-approved NSAIDs carried higher heart failure risk: ketorolac (odds ratio, 1.83), indomethacin (1.51), piroxicam (1.27), diclofenac (1.19), ibuprofen (1.18), and naproxen (1.16). The results were significant in patients regardless of their history of heart failure. Higher doses were associated with greater risk.
Editorialists conclude: "A more restricted policy by regulatory authorities on the availability of NSAIDs and requirements for healthcare professionals providing advice on their use and potential harm is warranted."
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Heavy Hydrogen (Deuterium) Makes Drugs Last Longer in the Body
Substituting a heavier form of hydrogen into drugs can slow their breakdown by the body, leaving them in the bloodstream longer. In other words, a patient can take the drug less often and this may even reduce the severity of side effects. The technology has been around for 40 years, but it has taken that long to understand it sufficiently to bring such a treatment before the FDA. The FDA is reviewing what would be the first medicine made with deuterium, or heavy hydrogen; a drug to treat a symptom of Huntington's disease. Teva hopes to submit more data to the FDA by the end of the month and hope the drug will reach patients next year.
http://www.bloomberg.com/news/articles/2016-09-16/a-decades-old-drug-technology-finally-nears-its-big-breakthrough?cmpid=yhoo.headline
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Benefits of Low Sodium Intake Still up in the Air
By Kelly Young, Edited by David G. Fairchild, MD, MPH
High sodium intake might be associated with increased mortality, while the effects of low sodium intake remain unclear, according to a study in the Journal of the American College of Cardiology.
Over 3000 pre-hypertensive adults were randomized to active sodium reduction or usual sodium intake for 18 months or 3–4 years. Multiple 24-hour urine samples were collected during the study. During a median follow-up of over 20 years, all-cause mortality was 15% lower with sodium reduction than with usual intake, but this was not statistically significant.
In a sub-analysis of the usual-sodium-intake group, mortality risk was 12% higher for every 1000 mg/24 hr increase in sodium excretion, but this only reached borderline significance. Very low sodium intake was not associated with mortality.
Editorialists conclude that these findings, along with past studies, “support modest reductions in sodium intake among persons consuming high-sodium diets.... However, the null effect of low sodium intake on mortality rates adds to the growing uncertainty about the health effects of low sodium intake.”
https://content.onlinejacc.org/article.aspx?articleID=2557459
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Children Who've Received Certain Alternative Therapies Appear Less Likely to Get Flu Shot
By Amy Orciari Herman, Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH
Children who receive certain complementary and alternative medicine (CAM) therapies might be less likely to get vaccinated against the flu, finds a Pediatrics study.
Researchers examined CAM use among some 9000 children whose parents completed the 2012 National Health Interview Survey. The proportion of children who’d ever used CAM ranged from roughly 4% for alternative medical systems (e.g., homeopathy, acupuncture) to about 7.5% for manipulative and body-based therapies (e.g., chiropractic or osteopathic manipulation) or biologically based therapies (e.g., herbals, vegetarian diet).
Influenza vaccination in the prior year was less common among children who’d ever used alternative medical systems (33%) or manipulative and body-based therapies (35%) than among children who hadn’t used these therapies (43%). Other types of CAM were not significantly associated with flu vaccination.
The authors write, “Opportunity exists for … medical professionals to improve child health by better engaging parents of children using particular domains of CAM."
http://pediatrics.aappublications.org/content/early/recent
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Teen Birth Rate Hits All-Time Low
By Kelly Young, Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS
The birth rate among adolescents hit a record low in 2015, dropping 8% from 2014, according to new data from the CDC's National Center for Health Statistics.
The birth rate in 2015 was 22.3 births per 1000 females aged 15 to 19 years. This rate has fallen 64% since 1991. Significant reductions have been seen for all races and ethnicities, although the rate remains highest in black and Hispanic teens.
Researchers say the decline could be explained by reductions in sexual activity among teens, increases in contraceptive use among sexually active teens, and increases in programs that aim to prevent teen pregnancy.
Despite these improvements, the report notes that the U.S. teen birth rate is still higher than that of other industrialized nations.
http://www.cdc.gov/nchs/products/databriefs/db259.htm
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Screening Colonoscopy Provides Little Benefit to Adults Aged 70–79
By Amy Orciari Herman
Screening colonoscopy appears to offer a modest benefit to adults aged 70–74 and little to no benefit to those aged 75–79, according to a study in the Annals of Internal Medicine. The U.S. Preventive Services Task Force recommends routine colorectal cancer screening for those aged 50–75, and screening on a case-by-case basis for those aged 76–85.
Researchers used Medicare data to follow a large group of older adults who hadn't undergone colonoscopy in the 5 years before baseline. Among adults aged 70–74, the estimated 8-year risk for colorectal cancer was 2.19% among those who subsequently underwent screening colonoscopy, versus 2.62% among those who did not. Among those aged 75–79, this modest benefit was even smaller: 2.84% versus 2.97%.
Screening colonoscopy was associated with an excess 30-day risk for adverse events requiring hospitalization or an emergency department visit: 5.6 excess events per 1000 adults aged 70–74 and 10.3 per 1000 among those aged 75–79.
http://annals.org/article.aspx?articleid=2556139
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Clinicians Less Likely to Counsel Low-Income Patients about Weight Loss
By Kelly Young, Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS
Low-income adults who are overweight or obese are less likely to be counseled to lose weight than adults with higher incomes, according to a study in Preventing Chronic Disease.
Researchers surveyed over 1100 overweight or obese adults from New Jersey about whether their healthcare provider had advised them in the past year about weight loss. A substantial proportion of participants had low incomes and were of a racial or ethnic minority.
Only 35% said they had recently been advised by a clinician to lose weight. After adjustment for health insurance status and other variables, participants whose household incomes were above 400% of the federal poverty level had a 64% increased odds of receiving weight loss advice, compared with those at or below the federal poverty level. Participants at 200–399% of that level had 56% higher odds.
https://www.cdc.gov/pcd/issues/2016/16_0183.htm
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DEA: Fewer Opioids to Be Manufactured Next Year
By the Editors of Journal Watch
The Drug Enforcement Administration has cut the amount of Schedule II opioid medications that can be legally manufactured in the U.S. by at least 25% for 2017. Production of hydrocodone in particular will be reduced even further, by 34% from the 2016 levels.
The DEA maintains an Aggregate Production Quota for controlled substances "necessary to meet the estimated medical, scientific, research, industrial, and export needs for the year and for the maintenance of reserve stocks." The reduction addresses the 25% buffer that was added in recent years to protect against shortages.
https://www.dea.gov/divisions/hq/2016/hq100416.shtml
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OnabotulinumtoxinA vs. Sacral Neuromodulation for Urgency Incontinence: No Clear Winner
By Amy Orciari Herman, Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
OnabotulinumtoxinA (Botox) confers small improvements in urgency incontinence relative to sacral neuromodulation, but it also carries significant adverse effects, a JAMA study finds.
Over 350 women with persistent urgency urinary incontinence, despite treatment with behavioral or physical therapy plus at least two anticholinergics, were randomized to receive onabotulinumtoxinA or sacral neuromodulation. OnabotulinumtoxinA (one 200-U dose) was given via cystoscopic intradetrusor injection, while neuromodulation involved permanent implantation of a neurostimulator. Participants averaged roughly five urgency incontinence episodes daily at baseline.
Over 6 months, the daily number of incontinence episodes decreased more with onabotulinumtoxinA than with neuromodulation; however, the difference between groups, while statistically significant, was small (reductions of 3.9 vs. 3.3 episodes/day).
Urinary tract infections were more common with onabotulinumtoxinA than with neuromodulation (35% vs. 11% of patients). In addition, 20% of onabotulinumtoxinA recipients required intermittent self-catheterization.
The researchers conclude: "Overall, these findings make it uncertain whether onabotulinumtoxinA provides a clinically important net benefit compared with sacral neuromodulation."
http://jamanetwork.com/journals/jama/article-abstract/2565290
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FDA Warns Against Use of Homeopathic Teething Tablets and Gels
By Amy Orciari Herman, Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH
Homeopathic teething tablets and gels should not be used as they might put infants and children at risk for seizures and other adverse events, the FDA warned on Friday. The products are distributed by CVS, Hyland's, and "possibly others," the agency said.
The FDA is testing product samples and evaluating adverse events that have been reported since 2010, when Hyland's Teething Tablets were recalled over potential safety issues. The agency notes that it has not approved such products, and it is "not aware of any proven health benefit."
Parents should be advised to seek medical care for their child immediately if he/she has any of the following after using homeopathic teething tablets or gels: seizures, trouble breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/
SafetyAlertsforHumanMedicalProducts/ucm523435.htm
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Elephant Tranquilizer Implicated in Recent Overdose Deaths
By the Editors of Journal Watch
The Drug Enforcement Administration is blaming a spate of recent overdose deaths on carfentanil, a synthetic opioid that is roughly 100 times as potent as fentanyl. Just 2 mg of fentanyl can be fatal, while the lethal dose of carfentanil is unknown.
Carfentanil is estimated to be 5000 times as potent as heroin and 10,000 times as potent as morphine.
A Schedule II substance, carfentanil is used to sedate large animals like elephants. It is often sold on the streets as heroin. Like with fentanyl, multiple doses of naloxone may be needed.
https://www.dea.gov/divisions/hq/2016/hq092216.shtml
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Taiwan Active Pharmaceutical Ingredient Plant Cited for Filthy, Smelly Rooms and Uncleaned Equipment
The FDA issued a warning letter to a Taiwanese active pharmaceutical ingredient (API) company, Taoyuan City-based Cheng Fong Chemical, after an inspection where investigators found a foul-smelling, filthy plant with insects and layers of unidentified material on the floors of rooms that had never been cleaned. The investigators found equipment that was corroded, dirty, pitted on the product surface of the equipment and leaking on and around the equipment. They also found cold rooms storing raw materials and intermediates used to make APIs that had foul odors and which officials acknowledged "had never been cleaned."
http://www.fiercepharma.com/manufacturing/fda-cites-taiwan-api-plant-for-its-filthy-smelly-rooms-uncleaned-equipment
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Early Infant Self-Feeding Does Not Increase Choking Risk
By Martin T. Stein, MD
Dr. Stein is an associate editor with NEJM Journal Watch Pediatrics and Adolescent Medicine, from which this story was adapted. Full coverage is available to subscribers at the link below.
Choking and gagging incidents are similar among infants who start solid food by self-feeding and those who are spoon-fed, according to aPediatrics study. Early infant self-feeding is seen as a potential strategy to allow babies to self-regulate caloric intake and reduce childhood obesity.
To evaluate the choking risk with this method, researchers randomized 206 infants to begin self-feeding with solid foods at age 6 months or to be fed the usual way. Mothers received a list of solid foods that pose a choking risk.
Between 6 and 8 months of age, 35% of infants choked at least once; there were no significant differences between the groups at any age through 12 months. Compared with controls, self-feeding infants gagged more frequently at 6 months but less frequently at 8 months. Infants self-resolved most choking incidents.
Comment: Until we have more randomized controlled trials and evidence that early self-feeding has a role in preventing obesity, I do not recommend initiating the early self-feeding program. Why change without known long-term benefits?
http://pediatrics.aappublications.org/content/early/2016/09/15/peds.2016-0772
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Early Introduction of Egg and Peanut Associated with Reduced Allergy Risks
By David J. Amrol, MD
Dr. Amrol is a contributing editor with NEJM Journal Watch Pediatrics and Adolescent Medicine, from which this story was adapted. Full coverage is available to subscribers at the link below.
Introducing infants to egg at ages 4–6 months and to peanut at ages 4–11 months was associated with reduced risk for allergy to those foods in a JAMA meta-analysis.
These findings were based on moderate-certainty evidence from randomized trials involving children at high or normal risk for each food allergy (five trials involving about 1900 children for early egg introduction and two trials involving some 1600 children for early peanut introduction).
Researchers also found high-certainty evidence of no association between timing of gluten introduction and celiac disease risk. Early food introduction was not associated with increased risk for allergic or autoimmune diseases in any of the 146 studies reviewed.
Comment: Although we still don’t know if this applies to other foods or in low-risk children, these data should reassure parents and pediatricians that children can start all foods between ages 4 and 12 months with no increased risk for allergic or autoimmune disease.
http://jamanetwork.com/journals/jama/article-abstract/2553447
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Measles Eradicated in the Americas
The Editors of Journal Watch
Measles has been eliminated in the Americas, the Pan American Health Organization/World Health Organization declared on Tuesday. It is the first region in the world to be free of endemic measles transmission. This follows a mass vaccination campaign against measles, mumps, and rubella.
The most recent endemic case of measles in the Americas occurred in Venezuela in 2002. Since then, 5000 cases have been imported from other regions.
Given the high number of cases in Africa and Asia, the PAHO/WHO recommends that countries in the Western Hemisphere strengthen their measles surveillance and continue vaccinating against the disease.
http://www.paho.org/hq/index.php?option=com_content&view=article&id=12528:region-americas-declared-free-measles&Itemid=1926&lang=en
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Report: First Baby Born with DNA from 3 People
By Kelly Young, Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
The first infant with DNA from three parents has been born, New Scientist reports.
A U.S. team performed the procedure, called spindle nuclear transfer, on a couple from Jordan in Mexico. The procedure is not approved in the U.S.
The mother has genes for Leigh syndrome and had four pregnancy losses and two children die from the neurological disorder. About a fourth of her mitochondria have the genetic mutation.
During the procedure, the nucleus of a donor egg was removed. The nucleus from the mother's egg was placed into the donor egg. The father's sperm fertilized this egg, which contained the mother's nuclear DNA and the donor's mitochondrial DNA. The fertilized egg was then implanted in the mother. The male infant is now 5 months old.
The team will present their work the American Society for Reproductive Medicine’s Scientific Congress in October.
https://www.newscientist.com/article/2107219-exclusive-worlds-first-baby-born-with-new-3-parent-technique/
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Genetically Modified Enzymes Used in Household Products Seen as "Potent Allergens"
By Amy Orciari Herman, Edited by Susan Sadoughi, MD
Genetically modified enzymes — used increasingly to create flavors and fragrances and to enhance the strength of detergents and medications — appear to be "potent allergens" for the industrial workers exposed to them, according to a pilot study in Occupational and Environmental Medicine.
Researchers tested blood samples for IgE antibodies from some 800 people exposed to enzymes in factories where they work. Roughly one-quarter of participants tested positive for antibodies against their particular workplace enzymes. In a subgroup of workers for whom clinical data were available, 17% reported wheezing/asthmatic dyspnea and 19% reported rhinitis/conjunctivitis associated with their jobs. Participants with higher antibody levels were more likely to report such symptoms.
Sensitization was particularly common for workers exposed to enzymes used in cleaning and home-care products.
The authors conclude: "Enzymes should be tested like any other potentially hazardous chemical."
http://oem.bmj.com/content/early/2016/08/23/oemed-2015-103442
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U.N. Tackles Antimicrobial Resistance
World leaders on Wednesday vowed to work together to solve the root causes of antimicrobial resistance during the U.N. General Assembly.
In the organization's history, it is only the fourth time the General Assembly has devoted time to a health issue. Others included HIV, non-communicable diseases, and Ebola.
Countries agreed to work on strengthening antimicrobial regulations, developing national plans to address antimicrobial resistance, and encouraging innovation in developing both alternatives to antimicrobials as well as new diagnostic technologies and vaccines.
http://www.who.int/mediacentre/news/releases/2016/commitment-antimicrobial-resistance/en/
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Cases of Acute Flaccid Myelitis Up Again in U.S.!
By Kelly Young
The U.S. has seen 50 confirmed cases of acute flaccid myelitis in 24 states from January through August this year.
The neurologic illness, which causes limb weakness, gained notice in 2014 with 120 confirmed cases, often in children; however, the number of cases waned the following year, down to 21. The CDC says that greater awareness of acute flaccid myelitis may have led to higher reporting recently.
Acute flaccid myelitis can be caused by enteroviruses, adenoviruses, and the West Nile virus (and other viruses in that same family), but the CDC still doesn't know the exact cause or risk factors for these recent cases.
Given the increase this year, the CDC reminds clinicians to be alert for potential acute flaccid myelitis and to report cases to their local health department.
http://www.cdc.gov/acute-flaccid-myelitis/afm-surveillance.html
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Morning Sickness Associated with Reduced Risk for Pregnancy Loss
By Kelly Young, Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD
Nausea and vomiting during pregnancy are associated with reduced risk for miscarriage, even in the earliest weeks of pregnancy, according to a JAMA Internal Medicine study.
Women with one or two prior pregnancy losses who were trying to conceive kept symptom logs and provided urine samples for pregnancy tests daily. Roughly 800 women who became pregnant were included; about one-fourth subsequently miscarried.
Women with nausea alone or nausea with vomiting in a given week had respectively 50% and 75% lower risks for pregnancy loss than women without symptoms. The results were statistically significant for clinically recognized pregnancy losses, but not for peri-implantation losses.
JAMA Internal Medicine commentators write: "As common as nausea and vomiting are in the first trimester, researchers and clinicians should be cautious about deeming it to have a protective effect against pregnancy loss. [Women] should not be discouraged from seeking treatment for a condition that can have a considerable negative effect on their quality of life."
http://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2553283
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Wearable Fitness Trackers Might Not Aid in Weight Loss
By Amy Orciari Herman, Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
Among young adults attempting to lose weight, adding a wearable device that tracks exercise and energy expenditure offers no benefit over a standard weight-loss intervention — and might even lead to less weight loss — a JAMA study finds.
Some 470 overweight or obese young adults were randomized to a standard or enhanced weight-loss intervention. All participants received a behavioral intervention that included calorie reduction, physical activity prescription, and group counseling. At 6 months, participants in the enhanced intervention group also began wearing a sensor (FIT Core) on their upper arms that tracked and offered feedback on physical activity and energy expenditure. The standard intervention group, meanwhile, simply started monitoring their diet and activity on a website at the 6-month mark.
At 24 months, the enhanced intervention group had lost significantly less weight than the standard intervention group (mean, 3.5 vs. 5.9 kg). Of interest, neither physical activity nor diet differed significantly between the groups during the study.
http://jamanetwork.com/journals/jama/article-abstract/2553448
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FDA Clears Balloon Device to Treat Eustachian Tube Dysfunction
By Amy Orciari Herman, Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH
The FDA has cleared for marketing a balloon device to treat persistent Eustachian tube dysfunction.
With the Aera Eustachian Tube Balloon Dilation System, a catheter is used to pass a small balloon through the patient's nose and into the Eustachian tube. The balloon is then inflated to open the tube, thus creating a path for mucus and air and potentially restoring normal middle-ear function. The balloon is removed after the Eustachian tube is dilated.
In a trial of some 300 patients, 52% of those treated with the balloon system achieved normal middle-ear function at 6 weeks, versus just 14% of those treated with nasal spray.
The device should not be used for patients younger than 22 years.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm521063.htm
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