ACCF/AHA 2011 Expert Consensus Document on Hypertension in the Elderly

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6015a4.htm?s_cid=mm6015a4_e&source=govdelivery

Announcements: World Malaria Day — April 25, 2011

Weekly

April 22, 2011 / 60(15);481

World Malaria Day is commemorated on April 25, the date in 2000 when 44 African leaders met in Abuja, Nigeria, and signed the Abuja Declaration, committing their countries to cutting malaria deaths in half by 2010. In the decade since, increased funding and efforts have led to a scale-up of effective malaria interventions in many countries. In 2009, malaria caused an estimated 781,000 deaths worldwide, down from an estimated 985,000 in 2000. In 32 of the 56 malaria-endemic countries outside Africa, the number of confirmed malaria cases declined more than 50%. By 2010, 11 countries and one area in the World Health Organization’s African Region showed a reduction of more than 50% in confirmed malaria cases or admissions and deaths (1).

The theme of World Malaria Day, “Achieving Progress and Impact,” highlights the successes worldwide and provides an opportunity to take stock of the current state of malaria globally and to consider how to achieve the U.N Secretary-General’s goal of near zero deaths by 2015. CDC contributes to these efforts through the President’s Malaria Initiative (PMI), a U.S. government interagency initiative to reduce malaria in 17 countries in sub-Saharan Africa and in the Greater Mekong subregion in Asia. PMI is led by the U.S. Agency for International Development (USAID) and is implemented by USAID and CDC, in collaboration with host ministries of health and local and international partners.

CDC also conducts multidisciplinary strategic and applied research globally to better understand malaria and develop safe, effective interventions that can lead to malaria’s elimination and eventual eradication. Additional information regarding CDC’s malaria activities is available at http://www.cdc.gov/malaria.

Reference

1. World Health Organization. World malaria report 2010. Geneva, Switzerland: World Health Organization; 2010. Available at http://www.who.int/malaria/world_malaria_report_2010/en/index.html. Accessed April 18, 2011.

http://www.medicalnewstoday.com/articles/218844.php

Medical New Today

Erectile Dysfunction Drug Improves Exercise Tolerance In Young People With Congenital Heart Disease

“….Sildenafil significantly improved measures of exercise performance during stress testing in patients with single-ventricle heart disease, according to researchers from The Children’s Hospital of Philadelphia.

This study was published online on March 7 in the journal Circulation. It is the first randomized, double-blind, placebo-controlled, crossover trial to evaluate the impact of sildenafil on measures of exercise performance in children and young adults with single-ventricle heart disease…..”

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm252392.htm

FDA NEWS RELEASE

For Immediate Release: April 22, 2011
Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves the first vaccine to prevent meningococcal disease in infants and toddlers

The U.S. Food and Drug Administration today approved the use of Menactra in children as young as 9 months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Menactra already is approved for use in people ages 2 through 55 years.

Meningococcal disease is a life-threatening illness caused by bacteria that infect the bloodstream (sepsis) and the lining that surrounds the brain and spinal cord (meningitis). Neisseria meningitidis is a leading cause of meningitis in young children. Even with appropriate antibiotics and intensive care, between 10 percent and 15 percent of people who develop meningococcal disease die from the infection. Another 10 percent to 20 percent suffer complications such as brain damage or loss of limb or hearing.

Although the rates of meningococcal disease are low in the United States, infants and toddlers are more susceptible to getting this serious illness. Meningococcal disease is particularly dangerous because it progresses rapidly and can cause death within hours. Early symptoms are often difficult to distinguish from influenza and other common illnesses.

“The highest rate of meningococcal disease occurs in children under one year of age. With today’s approval, Menactra can now be used in children as young as 9 months of age to help prevent this potentially life-threatening disease,” said Karen Midthun, M.D., director of FDA’s Center for Biologics Evaluation and Research.

The safety of Menactra in children as young as 9 months was evaluated in four clinical studies in which over 3,700 participants received the vaccine. The most common adverse events reported in children who received Menactra at 9 months and 12 months of age were injection-site tenderness and irritability. Occurrence of fever was comparable to other vaccines routinely recommended for young children.

Menactra is given as a two-dose series beginning at 9-months, three months apart; and the study results showed the vaccine produces antibodies in the blood that are protective against the disease.

Menactra was originally approved on Jan. 14, 2005, for use in individuals ages 11 years through 55 years and was approved in October 2007 for children as young as 2 years. Menactra is manufactured by Sanofi Pasteur Inc. of Swiftwater, Pa.

For more information:

• Menactra Product Page 

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm199965.htm

Tysabri (natalizumab): Update of Healthcare Professional Information

Audience: Neurological healthcare professionals, patients

[UPDATED Posted 04/22/2011] FDA has updated the Tysabri (natalizumab) Prescribing Information to give new information about the size of the risk of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection, associated with use of Tysabri for the treatment of multiple sclerosis (MS) and Crohn’s disease. The update includes new safety information about patients who have taken other drugs that suppress the immune system, who may be at a higher risk for PML. Tysabri, in a class of medications called immunomodulators, has been approved by the FDA for the treatment of relapsing forms of multiple sclerosis since November 2004 and for the treatment of moderately to severely active Crohn’s disease since January 2008. The revised label includes a table summarizing rates of PML with Tysabri use according to the number of infusions (how long the drug is taken or duration of exposure) and information on a newly identified PML risk factor.

[Posted 02/05/2010] FDA notified healthcare professionals and patients that the risk of developing progressive multifocal leukoencephalopathy (PML) increases with the number of Tysabri infusions received. This new safety information, based on reports of 31 confirmed cases of PML received by the FDA as of January 21, 2010, will now be included in the Tysabri drug label and patient Medication Guide. Information about the occurrence of Immune Reconstitution Inflammatory Syndrome (IRIS) in patients who have developed PML and subsequently discontinued Tysabri has also been added to the drug label. IRIS is a rare condition characterized by a severe inflammatory response that can occur during or following immune system recovery, causing an unexpected decline in a patient’s condition after return of immune function.

Based on the available information, FDA believes that the clinical benefits of Tysabri continue to outweigh the potential risks. Revisions to the drug label and patient Medication Guide, with the continued use of the TOUCH Prescribing Program, are intended to maximize the safe use of Tysabri and the identification of new PML cases.

[04/22/2011 - Drug Safety Communication¹ - FDA]

[02/05/2010 - Drug Safety Communication² - FDA]

Previous MedWatch Alerts:
[09/17/2009³]
[08/25/2008⁴]

Defining the Limits of Resuscitative Emergency Department Thoracotomy: A Contemporary Western Trauma Association Perspective

http://www.dailyrecord.com/article/20110416/NJNEWS/104160311/1002/NJSPORTS/Health-officials-issue-measles-alert-after-2-people-from-France-treated-St-Clare-s-Denville?odyssey=nav|head

Daily Record, NJ

Health officials issue measles alert after 2 people from France are treated at St. Clare’s in Denville

2 French youths may have exposed others

6:19 PM, Apr. 16, 2011

“Two young people from France showed up this week at St. Clare’s emergency room with measles……

The diagnosis of measles was confirmed by a state laboratory and prompted state and local health officials to issue an alert warning people to be aware of signs of the illness.

“They were staying with friends,” said Donald Allegra, an infectious disease doctor at St. Clare’s. “I’m not sure how much exposure to the community they had.”

Allegra said the two young adults are related and came together from France, arriving at Newark Liberty International Airport on April 7, three days before they developed a rash, a symptom of measles. They came to the St. Clare’s emergency room this past Tuesday evening and returned the next day, when Allegra said he examined them and diagnosed measles…..”

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6013a6.htm?s_cid=mm6013a6_e&source=govdelivery

Measles Outbreak — Hennepin County, Minnesota, February–March 2011

 MMWR Weekly

April 8, 2011 / 60(13);421

On March 2, 2011, the Minnesota Department of Health (MDH) confirmed measles in a Hennepin County resident aged 9 months. As of April 1, investigation of contacts and heightened surveillance had revealed a total of 13 epidemiologically linked cases in Hennepin County residents. Of those cases, 11 were laboratory confirmed, and two were in household contacts of confirmed cases and met the clinical case definition for measles.

The patients included children aged 4 months–4 years and one adult aged 51 years; seven of the 13 were of Somali decent. Eight patients were hospitalized. Vaccination status was known for 11 patients: five were too young to have been vaccinated, and six (all of Somali descent) had not been vaccinated because of parental concerns about the safety of the measles, mumps, and rubella (MMR) vaccine. The most recent rash onset was March 28. An additional, unrelated case of measles was confirmed in a Hennepin County resident aged 34 years who was exposed in Orlando, Florida, sometime during March 1–10.

The investigation determined that the index patient was a U.S.-born child of Somali descent, aged 30 months, who developed a rash February 15, 14 days after returning from a trip to Kenya. The patient attended a drop-in child care center 1 day before rash onset; measles developed in three contacts at the center and in one household contact. Secondary and tertiary exposures occurred in two congregate living facilities for homeless persons (four patients), an emergency department (two patients), and households (two patients). A virus isolate from the index patient was genotyped at CDC as B3, which is endemic in sub-Saharan Africa.

Outbreak control efforts have included following up with potentially exposed persons, providing immune globulin to persons without evidence of immunity, and recommending that persons without evidence of immunity who have been exposed to measles not leave their residence while potentially infectious (21 days). Multiple vaccination clinics have been held or scheduled at community venues and in the congregate living facilities.

In the United States, MMR vaccine normally is given as a 2-dose series, with the first dose at age 12–15 months and a second dose at age 4–6 years.* However, this series may be accelerated during outbreaks. In response to the current outbreak, MDH has recommended that children aged 6–11 months living in selected congregate living facilities receive a dose of MMR vaccine,† and that older children and adults in these facilities receive vaccine if they are susceptible and have had less than 2 doses of MMR vaccine. MDH also has recommended an accelerated vaccination schedule (a total of 2 doses of MMR vaccine separated by at least 28 days) for all children aged ≥12 months living in Hennepin County and all children of Somali descent living in the wider Minneapolis-St. Paul metropolitan area.

Measles was declared eliminated from the United States in 2000. However, importations of measles from other countries still occur, and low vaccination coverage associated with parental concerns regarding the MMR vaccine puts persons and communities at risk for measles. Public health and health-care providers should work with parents and community leaders to address concerns about the MMR vaccine to ensure high vaccination coverage and prevent measles.

Hot, blind, and mad: avoidable geriatric anticholinergic delirium
Published online: 04 April 2011
Kristen L. Ochs, Michele Zell-Kanter, Mark B. Mycyk, TOXIKON Consortium
DOI: 10.1016/j.ajem.2011.01.007
American Journal of Emergency Medicine, The, http://www.ajemjournal.com/article/S0735-6757%2811%2900016-7/abstract

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm250498.htm

FDA NEWS RELEASE

For Immediate Release: April 8, 2011
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA clears test for bacteria that can cause serious intestinal disease
Clostridium difficile can lead to diarrhea, colitis

The U.S. Food and Drug Administration today cleared a test called the Cepheid Xpert C. difficile/Epi assay that is designed to rapidly detect the toxin B gene associated with Clostridium difficile infection (CDI), a cause of diarrhea that can lead to colitis, other serious intestinal conditions and death in severe cases.

Clostridium difficile (C. difficile) bacteria are found in the stool of an infected person. Others can become infected if they touch items or surfaces contaminated with the bacteria or spores and then touch their mouth.

The Cepheid Xpert C. difficile/Epi assay is automated and works on the Cepheid GeneXpert Dx System to detect toxin gene sequences associated with toxigenic C. difficile. The Cepheid GeneXpert Dx System consists of an instrument that houses single-use disposable cartridges, a personal computer, and software that allow a laboratory technician to run tests and view test results quickly.

The test, Cepheid Xpert C. difficile/Epi assay, determines if C. difficile is in a patient’s stool and also detects if the C. difficile is the epidemic 027/NAP1/BI strain, which has been associated with a marked increase in the severity and incidence of CDI in North America and Europe over the past decade.

The test is intended for use as an aid in the diagnosis of CDI. The detection of the 027/NAP1/B1 strain is for epidemiological purposes only and should not be used to determine or monitor treatment. Health care facilities should monitor the number of C. difficile infections and, especially if rates at the facility increase, the severity of disease and patient outcomes.

“Health care professionals in the infectious disease community who have seen various outbreaks of CDI associated with aggressive strains in recent years now have a new testing tool to detect this disease,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health.

People at risk of developing the bacterial infection include the elderly, patients in hospitals or living in a nursing home, and people taking antibiotics for another infection. The most effective way to prevent CDI is thorough hand-washing with soap and warm water.

The Cepheid Xpert C. difficile/Epi test is made by Cepheid of Sunnyvale, Calif.

For more information:

FDA: Medical Devices
¹

FDA: Device Approvals and Clearances
²

CDC: Prevent Clostridium difficile Infection³

http://consumer.healthday.com/Article.asp?AID=651828

Abusive Head Trauma in Infants Doubled During Recession

Financial stress may trigger violent behavior toward babies, researchers say

By Madonna Behen,  HealthDay

WEDNESDAY, April 13 (HealthDay News) — “Recession-related stress may have triggered an alarming increase in non-accidental head injuries among infants, new research suggests.

The number of babies hospitalized for non-accidental head trauma — a form of child abuse previously known as shaken baby syndrome — doubled during the recent recession, according to the study by researchers at University Hospitals Rainbow Babies and Children’s Hospital in Cleveland…..”

http://consumer.healthday