viernes, 28 de agosto de 2015

U.S. Food & Drug Administration (FDA) Diabetes Update

FDA Diabetes Monitor

OmniPod (Pod) Insulin Management System by Insulet Corporation: Recall - Possibility of a Higher Rate of Failure

AUDIENCE: Risk Manager, Patient, Internal Medicine
ISSUE: Insulet Corporation initiated a lot-specific voluntary recall of 40,846 boxes (10 Pods per box) of the OmniPod (Pod) Insulin Management System. This field corrective action is due to the possibility that some of the Pods from these lots may have a higher rate of failure than Insulet's current manufacturing standards. This recall does not affect the OmniPod Personal Diabetes Manager (PDM).
There are two ways in which these Pods can fail at a rate that is higher than Insulet's current standard. The cannula may either completely retract or fail to fully deploy, which may result in the patient not receiving the expected insulin dose. Or the Pod may trigger an audible alarm indicating it will no longer deliver insulin and will need to be replaced. Both situations can result in the interruption of insulin delivery that can cause hyperglycemia, which, if left untreated, can result in diabetic ketoacidosis (DKA).
OmniPods from the affected lots were distributed to customers from December 2013 to March 2015. See the Press Release for a listing of affected lots.  
BACKGROUND: The affected Pod lots have resulted in 90 Medical Device Reports of which 13 required medical intervention. No serious injuries or deaths have been reported in patients using OmniPod devices from the affected lots.
RECOMMENDATION: Insulet has notified its distributors and customers by email, FedEx, and phone calls and is arranging for return and replacement of all recalled product. Consumers with questions may contact the Company via telephone at 1-855-407-3729 at any time.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Press Release, at:

Ivanhoe.com Top 10 Viewed Stories 8/28/2015

Medical Breakthroughs: Ivanhoe Insider

This Week's Top 10 Viewed Stories
         1. Fewer Moles, More Aggressive Melanoma
Aug. 20, 2015 - According to new research, those with fewer moles may be diagnosed with more aggressive melanoma than those with many ...
         2. Schizophrenia: Retinal Changes May Gives Clues (2nd week)
Aug. 17, 2015 - Schizophrenia is associated with structural and functional alterations of the visual system, including specific structural changes in the eye. Tracking such changes may provide new measures of risk ...
         3. Drinking Coffee Daily for Colon Cancer Patients (2nd week)
Aug. 17, 2015 - Regular consumption of caffeinated coffee may help prevent the return of colon cancer after treatment and improve the chances of a cure, according to a new, large study that reported this striking ...
         4. New Insight On How Parkinson’s Develops
Aug. 20, 2015 - Two proteins that share the ability to help cells deal with their trash appear to need each other to do their jobs and when ...
         5. Milk--Pros and Cons
SAN ANTONIO. (Ivanhoe Newswire) -- It used to be a no-brainer, almost everyone drank milk. Now, not so much. The reasons why are creating a healthy debate.
         6. Don’t Let the Bedbugs Bite
Aug. 20, 2015 - The number of bedbug infestations across the United States has risen over the past several years, and that’s bad news for travelers. Fortunately, there are precautionary measures that everyone can ...
         7. Ring and Sling for the Heart (2nd week)
MIAMI. (Ivanhoe Newswire) --- Atrial fibrillation, or Afib, affects more than one million Americans. It’s the most common form of heart arrhythmia and can greatly increase the risk of stroke. Now, doctors are using a minimally invasive procedure known as the “ring and sling” to treat the heart.
         8. Hammertoe Surgery
BALTIMORE. (Ivanhoe Newswire) -- Hammertoe is a condition where one or more toes are bent downward and frozen in an unnatural and uncomfortable position. The traditional method of fixing the toe can be painful, and require weeks of rehab. Now, a new procedure is making it easier for patients with hammertoe to get back on their feet.
         9. Preventing Flu Without a Vaccine? (2nd week)
Aug. 11, 2015 - Researchers have discovered a way to trigger a preventive response to a flu infection without any help from the usual players - the virus itself or interferon, a powerful infection fighter. The ...
         10. High Calorie Fruit
ORLANDO, Fla. (Ivanhoe Newswire) -- Instead of candy bars or cookies, a lot of diets urge you to eat fruit instead. But that substitution can have its own set of pitfalls, namely calories.

CDC MMWR- Morbidity and Mortality Weekly Report

MMWR- Morbidity and Mortality Weekly Report
MMWR News Synopsis for August 27, 2015
National, State, and Selected Local Area Vaccination Coverage Among Children Aged 19-35 Months – United States, 2014

High coverage rates for childhood vaccines explain why most vaccine-preventable diseases are at record low levels. However, it is crucial to maintain these rates to prevent the occurrence of outbreaks. Vaccinating children according to the recommended schedule is one of the best ways to protect them from several harmful and potentially deadly diseases before their second birthday. Following the recommended immunization schedule protects as many children as possible and prevents many potentially life-threatening diseases.According to the 2014 National Immunization Survey, the majority of parents are vaccinating their children against potentially serious diseases. Nationally, there were no significant decreases in vaccination coverage among children ages 19-35 months for routinely recommended childhood vaccines in 2014. As in past years, lower coverage was observed for vaccines recommended during the second year of life. There are still opportunities for improvement. While national coverage was high for most vaccines routinely recommended for young children, vaccination coverage does vary by state and poverty status.

Vaccination Coverage Among Children in Kindergarten — United States, 2014–15 School Year

Maintaining high vaccination coverage among school-age children is critical for protecting children because diseases can quickly spread through schools and communities if children are unvaccinated. Nationally, for the 2014-2015 school year, most kindergarteners were up-to-date on their recommended vaccinations. For the 2014-2015 school year, median exemption levels were low, but vary by state. Although statewide levels of vaccination coverage were high, locally there may be clusters of under-vaccinated or unvaccinated students that put their schools or communities at a higher risk for an outbreak. Maintaining high vaccination coverage among school-age children is critical for protecting children because diseases can quickly spread through schools and communities if children are unvaccinated. CDC urges parents to give their children the best protection from vaccine-preventable diseases like measles and chicken pox by ensuring that their children are vaccinated according to the recommended immunization schedule.

School-Level Practices to Increase Availability of Fruits, Vegetables, and Whole Grains and Reduce Sodium in School Meals — United States, 2014

Most schools in the U.S. are implementing healthy practices to help meet federal school meal standards by offering whole grains, more fruits and vegetables, and reducing sodium content. However, opportunities still exist to improve school nutrition services practices.Students consume almost half of their daily calories at school, often through federal school meal programs. In 2012, USDA published new requirements for school meals including serving more fruits, vegetables, and whole grains and gradually reducing sodium over 10 years. This study found that most schools are implementing practices to help meet the standards, including offering a variety of fruits and vegetables each day at lunch, offering whole grain items each day at breakfast and lunch, and using purchasing and food preparation strategies to reduce sodium content of meals. Although U.S. schools are moving in the right direction, schools should continue striving to provide a quality nutrition environment for students.


Injuries from Methamphetamine-Related Chemical Incidents — Five States, 2001–2012

Recent trends in injuries related to illegal methamphetamine manufacture suggest a need for efforts to protect the general public, particularly children and law enforcement officials. Because individual state legislative actions can result in increased illegal meth production in neighboring states, a regional approach to prevention is recommended. Methamphetamine, a highly addictive drug, can be illegally manufactured using easily acquired chemicals. Meth production can cause fires, explosions, injuries, and environmental contamination. CDC analyzed injury incidence and trends by examining 2001-2012 data on 1,325 meth-related chemical incidents reported to the Agency for Toxic Substances and Disease Registry’s Hazardous Substances Emergency Events Surveillance system and National Toxic Substance Incidents Program by Louisiana, Oregon, Utah, New York, and Wisconsin. Meth-related chemical incidents increased with the drug’s popularity (2001–2004), declined with legislation limiting access to precursor chemicals (2005–2007), and increased again as drug makers circumvented precursor restrictions (2008–2012). Seven percent of meth-related chemical incidents resulted in injuries to 162 persons, mostly members of the general public, including children and law enforcement officials.

World Health Organization Guidelines for Biocontainment of Poliovirus Following Type-Specific Polio Eradication – Worldwide, 2015

After certification of wild poliovirus eradication, the use of all oral poliovirus vaccine (OPV) will cease. Final containment of all polioviruses after polio eradication and OPV cessation will minimize the risk for reintroduction of poliovirus into a polio-free world. The containment of polioviruses in laboratories is a critical component of polio eradication. This report summarizes critical steps for essential laboratory and vaccine production facilities that intend to retain materials confirmed to contain or potentially containing wild poliovirus, vaccine-derived poliovirus, or OPV/Sabin viruses, as well as steps for nonessential facilities that process specimens that contain or might contain polioviruses. National authorities will need to certify that the essential facilities they host meet containment requirements. National authorities in all countries are currently tasked with completing a survey of laboratories and an inventory of where infectious and potentially infectious materials are held, and to prepare for the next phases of containment when only essential facilities will be able to hold such materials.


Notes from the Field:
  • Snowstorm-Related Mortality — Erie County, New York, November 2014
  • Increase in Reports of Strongyloides Infection — Los Angeles County, 2013–2014



QuickStats
  • Percentage of Children and Adolescents Aged 5–17 Years with Diagnosed Attention-Deficit/Hyperactivity Disorder (ADHD), by Race and Hispanic Ethnicity — National Health Interview Survey, United States, 1997–2014

QuickStats: Percentage of Children and Adolescents Aged 5–17 Years with Diagnosed Attention-Deficit/Hyperactivity Disorder (ADHD),* by Race and Hispanic Ethnicity — National Health Interview Survey,† United States, 1997–2014

QuickStats: Percentage of Children and Adolescents Aged 5–17 Years with Diagnosed Attention-Deficit/Hyperactivity Disorder (ADHD),* by Race and Hispanic Ethnicity — National Health Interview Survey,† United States, 1997–2014

MMWR Logo
MMWR Weekly
Vol. 64, No. 33
August 28, 2015
PDF of this issue




QuickStats: Percentage of Children and Adolescents Aged 5–17 Years with Diagnosed Attention-Deficit/Hyperactivity Disorder (ADHD),* by Race and Hispanic Ethnicity — National Health Interview Survey, United States, 1997–2014

Weekly

August 28, 2015 / 64(33);925-925

The figure above is a line chart showing that from 1997-1999 to 2012-2014, the percentage of all children aged 5-17 years with diagnosed attention-deficit/hyperactivity disorder (ADHD) increased significantly from 7.0% to 10.2%, and so did the prevalence among non-Hispanic white children (8.4% to 12.5%), non-Hispanic black children (5.5% to 9.6%), and Hispanic children (3.8% to 6.4%). Throughout 1997-2014, Hispanic children were the least likely to have diagnosed ADHD.

* Based on responses to the question, "Has a doctor or health professional ever told you that (child) had attention-deficit/hyperactivity disorder (ADHD) or attention deficit disorder (ADD)?"
† Estimates are based on household interviews of a sample of the civilian noninstitutionalized U.S. population and are derived from the National Health Interview Survey's Sample Child component.
From 1997–1999 to 2012–2014, the percentage of all children aged 5–17 years with diagnosed attention-deficit/hyperactivity disorder (ADHD) increased significantly from 7.0% to 10.2%, and so did the prevalence among non-Hispanic white children (8.4% to 12.5%), non-Hispanic black children (5.5% to 9.6%), and Hispanic children (3.8% to 6.4%). Throughout 1997–2014, Hispanic children were the least likely to have diagnosed ADHD.
Source: National Center for Health Statistics, CDC. National Health Interview Survey. Available at http://www.cdc.gov/nchs/nhis.htm.
Reported by: Patricia Pastor, PhD, ppastor@cdc.gov, 301-458-4422; Catherine Duran; Cynthia Reuben, MA.
Alternate Text: The figure above is a line chart showing that from 1997-1999 to 2012-2014, the percentage of all children aged 5-17 years with diagnosed attention-deficit/hyperactivity disorder (ADHD) increased significantly from 7.0% to 10.2%, and so did the prevalence among non-Hispanic white children (8.4% to 12.5%), non-Hispanic black children (5.5% to 9.6%), and Hispanic children (3.8% to 6.4%). Throughout 1997-2014, Hispanic children were the least likely to have diagnosed ADHD.

Errata: Vol. 63, No. 45

Errata: Vol. 63, No. 45

MMWR Logo
MMWR Weekly
Vol. 64, No. 33
August 28, 2015
PDF of this issue


Errata: Vol. 63, No. 45

Weekly

August 28, 2015 / 64(33);924-924


In the report, "Tobacco Use Among Middle and High School Students — United States, 2013," two errors occurred on page 1024 in the third and fourth footnotes under Table 2. Those footnotes should read as follows:
§ Any tobacco product use is ever use of cigarettes, cigars, smokeless tobacco, tobacco pipes, bidis, kreteks, hookah, snus, dissolvable tobacco, and/or electronic cigarettes.
Two or more tobacco product use is ever use of products from two or more of the following categories: cigarettes, cigars, smokeless tobacco, tobacco pipes, bidis, kreteks, hookah, snus, dissolvable tobacco, and/or electronic cigarettes.

Errata: Vol. 64, No. RR-3

Errata: Vol. 64, No. RR-3

MMWR Logo
MMWR Weekly
Vol. 64, No. 33
August 28, 2015
PDF of this issue


Errata: Vol. 64, No. RR-3

Weekly

August 28, 2015 / 64(33);924-924


In the MMWR Recommendations and Reports entitled "Sexually Transmitted Diseases Treatment Guidelines, 2015," several errors occurred.
On page 50 in the box, the bullet under "Positive Control" should read: "Commercial histamine for scratch testing (1.0 mg/mL)"
On page 93, the second sentence under the heading "Anal Cancer" should read: "However, an annual digital anorectal examination may be useful to detect masses on palpation that could be anal cancer in persons with HIV infection and possibly HIV-negative MSM with a history of receptive anal intercourse."
On page 101, in the recommendations box under "Alternative Regimens," it should read: "Malathion 0.5% lotion applied to affected areas and washed off after 8–12 hours OR Ivermectin 250 ug/kg orally, repeated in 2 weeks."
On page 102, in the recommendations box, the dagger footnote should be placed after "Lindane."
On page 103, the fifth sentence under the heading "Crusted Scabies," should read: "Combination treatment is recommended with a topical scabicide, either 25% topical benzyl benzoate or 5% topical permethrin cream (full-body application to be repeated daily for 7 days then two times weekly until discharge or cure), and treatment with oral ivermectin 200 ug/kg on days 1,2,8,9, and 15."

Increase in Reports of Strongyloides Infection — Los Angeles County, 2013–2014

Increase in Reports of Strongyloides Infection — Los Angeles County, 2013–2014

MMWR Logo
MMWR Weekly
Vol. 64, No. 33
August 28, 2015
PDF of this issue




Increase in Reports of Strongyloides Infection — Los Angeles County, 2013–2014

Weekly

August 28, 2015 / 64(33);922-923


Curtis Croker, MPH1Rosemary She, MD2
During the 1990s, reports of infection with the nematode (roundworm) Strongyloides stercoralis submitted to the Los Angeles County Department of Public Health (LACDPH) ranged from 40 to 50 per year, but by 2000, reports had decreased to five per year; in 2006, Strongyloides infection was removed from the LACDPH reportable disease list. Currently, it is only reported at the discretion of Los Angeles County clinicians and laboratories as an unusual disease occurrence. LACDPH currently only monitors case counts and does not investigate reported Strongyloides cases. During 2013–2014, an increase in Strongyloides cases occurred, with 43 cases reported.
Although Strongyloides infects humans worldwide, typically through skin contact with contaminated soil (1), infection is rare in the United States. Persons at risk for infection include immigrants, refugees, military veterans who have lived in areas where Strongyloides is endemic, (1) and persons who have lived in rural areas of the southeastern United States (2). Most infections are asymptomatic and might remain latent for decades. Persons with latent infection who receive immunosuppressive treatments or are otherwise immunosuppressed are at risk for a severe hyperinfection syndrome and disseminated disease, which is associated with a high mortality rate (3). During 1991–2006, the number of Strongyloides-associated deaths in the United States listed on death certificates ranged from 14 to 29 annually (4). Eosinophilia is the most common indicator of infection, but it is not specific to this disease and is not always present (5).
Beginning in 2013, Strongyloides case reports in Los Angeles County increased; no cases were reported in 2012, but 14 were reported in 2013 and 29 in 2014. Twenty-five (58%) of these reports were submitted by CDC's parasitic serology reference laboratory, for patients examined at Los Angeles County–University of Southern California Medical Center (LAC-USC). Sixteen reports were submitted by refugee health clinics, and two by other health care providers. The increase in case reports prompted a review of the 25 patients with Strongyloides examined at LAC-USC, a facility that accounts for 3% of all hospitalizations in a county of nearly 10 million residents.
The patients with Strongyloides examined at LAC-USC were mostly male (76%), Hispanic (80%), or Asian (16%). Most were foreign born (75%), primarily from a Latin American country (60%). The average patient age was 50 years (median = 55 years; range = 25–73 years). All patients tested positive for Strongyloides-specific antibody by enzyme immunoassay (EIA) testing performed by the CDC reference laboratory, indicating current or recent infection (6). The average test reaction value was 25.76 units/µl (range = 2.37–75.58 units/µl; reference 1.7 units/µl). Four were immunocompromised. Three patients were hospitalized at the time of testing; no patient had a diagnosis of disseminated disease or hyperinfection.
Of the 25 patients, 21 (88%) had peripheral eosinophilia (>450 eosinophils/µl) at the time of Strongyloides testing; the average eosinophil count was 1,297/µl (range = 201–3,472/µl). Nearly all patients (96%) had documentation of eosinophilia at some point during the 6 months preceding Strongyloides testing. Most were tested in an outpatient facility (88%), and many were being followed for other chronic health conditions such as hypertension (52%) or diabetes (48%), where eosinophilia appeared to be an incidental finding. Treatment was documented for 17 patients (68%), consisting of ivermectin alone for 15 patients, albendazole alone for one patient, and both drugs for one patient.
The recent increase in reports of Strongyloides in Los Angeles County is likely the result of screening guidelines published in 2012, which recommend screening all persons with a potential Strongyloides exposure history who are at risk for disseminated disease, including persons requiring immunosuppressive therapy (7), and changes in existing screening protocols, rather than an actual increase in disease prevalence. The high prevalence of eosinophilia among persons with latentStrongyloides infection in Los Angeles County highlights the importance of screening persons with eosinophilia for whom more common causes have been ruled out. Diagnosis of latent infection is important so that treatment can be initiated and the risk for more severe disease eliminated, and is crucial for persons with unexplained eosinophilia who will be placed on immunosuppressive drug regimens (7).
The burden of disseminated disease and hyperinfection in Los Angeles County remains unknown. Further research is needed to better characterize the at-risk group in Los Angeles County and enhance screening policies.
1Acute Communicable Disease Control Program, Los Angeles County Department of Public Health, California; 2Keck School of Medicine of the University of Southern California, Los Angeles, California.
Corresponding author: Curtis Croker, ccroker@ph.lacounty.gov, 213-240-7941.

References

  1. CDC. Traveler's health. Chapter 3: infectious disease related to travel. Atlanta, GA: US Department of Health and Human Services, CDC; 2015. Available athttp://wwwnc.cdc.gov/travel/yellowbook/2014/chapter-3-infectious-diseases-related-to-travel/strongyloidiasis.
  2. CDC. Notes from the field: strongyloidiasis in a rural setting—southeastern Kentucky, 2013. Morb Mortal Wkly Rep 2013;62:843.
  3. CDC. Parasites. Strongyloides: resources for health professionals. Atlanta, GA: US Department of Health and Human Services, CDC; 2015. Available athttp://www.cdc.gov/parasites/strongyloides/health_professionals/.
  4. Croker C, Reporter R, Redelings M. Strongyloidiasis-related deaths in the United States, 1991–2006. Am J Trop Med Hyg 2010;83:422–6.
  5. Naidu P, Yanow SK, Kowalewska-Grochowska KT. Eosinophilia: a poor predictor of Strongyloides infection in refugees. Can J Infect Dis Med Microbiol 2013;24:93–6.
  6. Loutfy MR, Wilson M, Keystone JS, Kain KC. Serology and eosinophil count in the diagnosis and management of strongyloidiasis in a non-endemic area. Am J Trop Med Hyg 2002;66:749–52.
  7. Mejia R, Nutman TB. Screening, prevention, and treatment for hyperinfection syndrome and disseminated infections caused by Strongyloides stercoralis.Curr Opin Infect Dis 2012;25:458–63.