• More Evidence that Cranberry Products don't Prevent Urinary Tract Infections
• New Testosterone Label Warns Clinicians of Abuse Potential
• New Guideline says Calcium, Vitamin D intake doesn't Adversely
Affect Cardiovascular Health
• Pregnancy might Increase Stroke Risk in Younger, but not Older, Women
• USPSTF Finalizes Recommendation on Breast-Feeding Promotion in Primary Care
• Obstetrics Group Recommends Against Giving Birth in Water
• No Increased Breast Cancer Risk Seen with GLP-1 Receptor Agonists
• DOJ Demands Information on Pharma Deals from Express Scripts
• Interpharm's Czech Plant gets FDA Warning Letter
• New Diabetes Guidelines Recommend that Patients Move Every 30 Minutes
• Chinese Pharmaceutical Plants Slammed by FDA
• Alternative Epinephrine Auto-Injector Returning to Market — Price Unknown
More Evidence that Cranberry Products don't Prevent Urinary Tract Infections
By Amy Orciari Herman, Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS
Cranberry capsules did not help prevent bacteriuria plus pyuria in a study of nursing home residents published in JAMA. An editorialist concludes that the evidence to date "is convincing that cranberry products should not be recommended as a medical intervention for the prevention of UTI."
Some 185 women aged 65 and older and living in nursing homes were randomized to receive two cranberry capsules or placebo capsules daily. Each cranberry capsule contained 36 mg of proanthocyanidin, about the amount found in 10 oz of cranberry juice.
During 1 year of follow-up, the incidence of bacteriuria plus pyuria did not differ between the groups (about 29%). In addition, secondary outcomes — including death, hospitalization, multidrug-resistant gram-negative bacilli bacteriuria, antibiotics given for suspected urinary tract infection, and overall antimicrobial use — did not differ significantly between the groups.
http://jamanetwork.com/journals/jama/fullarticle/2576822
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New Testosterone Label Warns Clinicians of Abuse Potential
The FDA is updating the labels for all prescription testosterone products to warn of their potential for abuse and dependence. Adverse effects linked to testosterone abuse include myocardial infarction, heart failure, stroke, male infertility, depression, and aggression.
Testosterone abuse often occurs with other anabolic androgenic steroids and at higher doses than what is prescribed. Withdrawal symptoms have included fatigue, irritability, loss of appetite, reduced libido, and insomnia.
If abuse is suspected, clinicians should measure serum levels of testosterone.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/
SafetyAlertsforHumanMedicalProducts/ucm526151.htm
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New Guideline says Calcium, Vitamin D Intake doesn't Adversely Affect Cardiovascular Health
By Kelly Young
The National Osteoporosis Foundation and the American Society for Preventive Cardiology have determined that calcium in food or supplements doesn't have an effect on incident cardiovascular or cerebrovascular disease, disease-related mortality, or all-cause mortality in most healthy adults.
The new guideline, based on a meta-analysis also published in the Annals of Internal Medicine, says that the addition of vitamin D also appears to have no effect.
The groups recommend that total calcium consumption less than the tolerable upper level of intake (2000–2500 mg daily) "should be considered safe from a cardiovascular standpoint."
Editorialists conclude: "Most persons require no more than 500 mg of supplemental calcium to meet their daily needs, if not met by diet alone. Achieving the recommended intakes of vitamin D (600 IU/d for adults up to age 70 and 800 IU/d for those aged 70 or older) also is essential. Based on the totality of evidence for both calcium and vitamin D, more is not better."
We ran a poll with this story earlier this week. Thanks to the 1,562 of you who voted. Here are the results:
Do you generally recommend that your healthy adult patients take calcium supplements?
Yes, with vitamin D: 24%
Yes, without D: 1%
No: 37%
Only certain patients: 38%
http://annals.org/aim/article/2571714/lack-evidence-linking-calcium-without-vitamin-d-supplementation-cardiovascular-disease
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Pregnancy might Increase Stroke Risk in Younger, but not Older, Women
By Amy Orciari Herman, Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD
Pregnancy is associated with increased stroke risk among women younger than 35, but not among older women, according to a retrospective study in JAMA Neurology.
Using a New York state inpatient database, researchers identified over 19,000 females aged 12–55 who were hospitalized with a cerebrovascular event over a decade. Stroke events included transient ischemic attack, ischemic and hemorrhagic stroke, and cerebral venous thrombosis.
Overall, 4% of strokes occurred during pregnancy or in the 6 weeks afterward. Among females aged 12–24, the incidence of pregnancy-associated stroke was 14 per 100,000 pregnant or postpartum women, while non-pregnancy-associated stroke occurred in just 6 per 100,000 nonpregnant women. Pregnancy also conferred higher stroke risk in those aged 25–34: roughly 21 strokes per 100,000 pregnant/postpartum women, versus 14 per 100,000 nonpregnant women. Similar risk increases were not observed among women aged 35–55.
Dr. Allison Bryant of NEJM Journal Watch Women's Health weighed in: "It is not surprising that the prothrombotic state of pregnancy elevates the risk for stroke, particularly among young women, in whom the baseline risk is low. Clinicians should remain vigilant about the risk factors, signs, and symptoms of stroke in pregnancy and the postpartum period."
http://jamanetwork.com/journals/jamaneurology/fullarticle/2570547
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USPSTF Finalizes Recommendation on Breast-Feeding Promotion
in Primary Care
By Amy Orciari Herman, Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
Primary care clinicians should provide interventions during a woman's pregnancy and after delivery to promote breast-feeding, the U.S. Preventive Services Task Force advises in a new recommendation statement. The grade B recommendation aligns with the group's 2008 guidance.
Upon reviewing the evidence, the group concluded "with moderate certainty" that the benefits of interventions — including one-to-one counseling by a clinician and peer support — outweigh the risks. Such interventions can increase breast-feeding rates and duration, which in turn are associated with improved infant, child, and maternal outcomes. Risks, meanwhile, "are no greater than small."
The recommendation doesn't apply to women who deliver prematurely, nor to those with medical conditions that may interfere with breastfeeding. Additionally, the USPSTF offers this caveat: "Not all women choose to or are able to breastfeed. Clinicians should, as with any preventive service, respect the autonomy of women and their families to make decisions that fit their specific situation, values, and preferences."
http://jamanetwork.com/journals/jama/fullarticle/2571249
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Obstetrics Group Recommends Against Giving Birth in Water!
By Amy Orciari Herman
The second stage of labor and delivery should take place "on land, not in water," according to a new statement from the American College of Obstetricians and Gynecologists.
The group says there aren't enough data to assess the benefits and risks of water immersion during this stage of labor, and serious adverse outcomes have been reported, including infection with Pseudomonas aeruginosa and Legionella pneumophila.
ACOG also advises the following:
- Water immersion may be offered during the first stage of labor in healthy women with uncomplicated pregnancies between 37 and 42 weeks' gestation. Data from randomized trials suggest immersion at this stage may decrease the duration of labor and the use of spinal and epidural analgesia.
- Women who ask for a water delivery should be informed of the inadequate data regarding the benefits and risks.
- Sites that choose to offer water immersion during delivery "need to establish rigorous protocols" regarding candidate selection, pool cleaning, and infection control.
http://www.acog.org/Resources-And-Publications/Committee-Opinions/Committee-on-Obstetric-Practice/Immersion-in-Water-During-Labor-and-Delivery
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No Increased Breast Cancer Risk Seen with GLP-1 Receptor Agonists
By Kelly Young, Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH
Use of glucagon-like peptide-1 (GLP-1) receptor agonists is not associated with elevated breast cancer risk, compared with use of dipeptidylpeptidase-4 (DPP-4) inhibitors, suggests an observational study in The BMJ. (Earlier studies have suggested a possible risk increase.)
Using data from a UK general practice database, researchers studied 45,000 women aged 40 and older who were newly prescribed a noninsulin diabetes drug (e.g., GLP-1 receptor agonists, DPP-4 inhibitors). After a mean follow-up of 3.5 years, 550 women were diagnosed with breast cancer.
Rates of incident breast cancer were similar between users of GLP-1 receptor agonists and DPP-4 inhibitors (4.4 vs. 3.4 per 1000 person years). Increased risk was observed with 2–3 years' of GLP-1 receptor agonist use, but that returned to null levels after longer use.
Nevertheless, editorialists caution: "Before prescribing, providers should discuss the balance of risks and benefits with all eligible patients, including a possible small increase in risk of breast cancer."
http://www.bmj.com/content/355/bmj.i5340
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DOJ Demands Information on Pharma Deals from Express Scripts
Congressional pharma critics are starting to investigate pharmacy benefit managers. Turns out the U.S. Justice Department already had one of the industry's largest under a microscope. Express Scripts has disclosed that the U.S. Attorney's offices in New York and Massachusetts had demanded information about two different issues: 1) financial ties with pharma companies, and 2) relationships among drugmakers, patient assistance programs, and the specialty pharmacies that fill prescriptions. Specifically requested is information about money changing hands between Express Scripts and pharma companies, including rebates that drugmakers pay to win favorable reimbursement deals for their products.
http://www.fiercepharma.com/pharma/doj-turns-tables-express-scripts-demands-info-pharma-deals
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Interpharm's Czech Plant gets FDA Warning Letter
A Czech drugmaker that ships both active pharmaceutical ingredients and finished products to the U.S. has come under fire from the FDA in a warning letter for data integrity issues. It lists about a dozen steps it wants the company to take to improve its systems. There is a lack of controls and routine purging of data by analysts; the company's quality-control unit does not have all of the information it needs to make informed decisions about whether products are safe and effective and meet U.S. standards.
http://www.fiercepharma.com/manufacturing/interpharm-gets-fda-warning-letter-for-czech-plant
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New Diabetes Guidelines Recommend that Patients Move Every 30 Minutes
By Kelly Young, Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM
The American Diabetes Association now recommends that patients with diabetes take a break from prolonged sitting every 30 minutes, citing blood glucose benefits. This could mean 3 or more minutes of standing, walking, or doing light-intensity activities like office chair swivels. Previously, the group recommended movement breaks every 90 minutes.
The group's first comprehensive physical activity guidelines, published inDiabetes Care, also make the following recommendations:
- Physical activity should be prescribed to all patients with diabetes.
- Patients should aim to get at least 150 minutes of physical activity every week. Both resistance and aerobic training are encouraged. Patients should go no more than 2 consecutive days without activity.
- Older adults with diabetes should aim for 2–3 days a week of flexibility or balance training, such as tai chi or yoga.
The document also provides guidance for youth, pregnant patients, physical activity considerations with various diabetes complications, and suggested carbohydrate intake before exercise.
http://care.diabetesjournals.org/content/39/11/2065
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Chinese Pharmaceutical Plants Slammed by FDA
Two Chinese companies with ties to Western drugmakers have been called
Two Chinese companies with ties to Western drugmakers have been called on the mat to account for problems in their manufacturing plants. Shanghai Desano Chemical Pharmaceutical and Chongqing Lummy Pharmaceutical were caught manipulating testing and turning in falsified batch test results on active pharmaceutical ingredients. The FDA found 8,400 unofficial chromatographic analyses at the Desano plant. The FDA states that all data needs to be reviewed by the plant's quality unit before deciding whether to release batches. The FDA also found many electronic logs of production deviations in a folder titled "GMP Anomalies" that had never been investigated.
http://www.fiercepharma.com/manufacturing/fda-slams-two-chinese-drugmakers-warning-letters
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Alternative Epinephrine Auto-Injector Returning to Market — Price Unknown
By Joe Elia, Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM
Auvi-Q, an alternative to the epinephrine autoinjector EpiPen, will return to the market in early 2017, its manufacturer Kaléo announced on Wednesday. Indicated for severe allergic reactions, the device uses audio prompts to guide the user through the process of injection.
Auvi-Q was taken off the market in 2015 owing to concerns over quality control. It is now manufactured using an automated system that mandates over 100 quality checks on each device, the company said.
In a conversation with Physician's First Watch, Kaléo CEO Spencer Williamson said the company was still "working with stakeholders" to set the price. He said that "the most important price is the price to the patient."
When taken off the market last year, Auvi-Q was priced close to Mylan's EpiPen, then selling for over $500 for a two-pack.
Meanwhile on Wednesday, a Texas law firm announced a class-action suit against Mylan over EpiPen's marketing.
http://www.multivu.com/players/English/7940951-auvi-q-epinephrine-auto-injector-comeback/
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