Archive for January, 2011

Cerebral air embolism from a very unusual source

A Case Report of Cerebral Air Embolism after Esophagogastroduodenoscopy:
Diagnosis and Management in the Emergency Department
Published online: 18 January 2011
Ananda V. Pandurangadu, Jose A.P. Paul, Mohammed Barawi, Charlene B. Irvin
DOI: 10.1016/j.jemermed.2010.11.031
Journal of Emergency Medicine

http://www.jem-journal.com/article/S0736-4679%2810%2900999-6/abstract

Warfarin, Trauma & The Risk of Death

http://consumer.healthday.com/Article.asp?AID=648958

Warfarin Use May Raise Risk of Death From Traumatic Injuries

Researchers found chances almost doubled; say ER docs need to check elderly patients

By Ellin Holohan
HealthDay Reporter

MONDAY, Jan. 17 (HealthDay News) — “New research shows that the risk of dying after suffering a traumatic injury is much higher for people taking warfarin…….The study found that of more than 1.23 million patients who went to emergency rooms with serious injuries, those taking warfarin (Coumadin) were almost twice as likely to die (9.3 percent vs. 4.8 percent)……”

Multaq (dronedarone): Risk of Severe Liver Injury

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm240110.htm

Multaq (dronedarone) – Drug Safety Communication: Risk of Severe Liver Injury

[Posted 01/14/2011]

AUDIENCE: Cardiology, Gastroenterology

ISSUE: FDA notified healthcare professionals and patients about cases of rare, but severe liver injury, including two cases of acute liver failure leading to liver transplant in patients treated with the heart medication dronedarone (Multaq). Information about the potential risk of liver injury from dronedarone is being added to the WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS sections of the dronedarone labels.

BACKGROUND: Dronedarone is a drug used to treat abnormal heart rhythm in patients who have had an abnormal heart rhythm during the past six months. Dronedarone was approved with a Risk Evaluation and Mitigation Strategy (REMS) with a goal of preventing its use in patients with severe heart failure or who have recently been in the hospital for heart failure. In a study of patients with these conditions, patients given dronedarone had a greater than two-fold increase in risk of death.

RECOMMENDATION: Healthcare professionals were reminded to advise patients to contact a healthcare professional immediately if they experience signs and symptoms of hepatic injury or toxicity (anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching) while taking dronedarone. Healthcare professionals should consider obtaining periodic hepatic serum enzymes, especially during the first 6 months of treatment. Additional information for Healthcare Professionals, for Patients and a Data Summary is provided in the Drug Safety Communication.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • 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

[01/14/2011 - Drug Safety Communication - FDA]

Lantus & the Big “C”

http://www.fda.gov/Drugs/DrugSafety/ucm239376.htm

FDA Drug Safety Communication: Update to ongoing safety review of Lantus (insulin glargine) and possible risk of cancer

Safety Announcement

[1-12-2011] The U.S. Food and Drug Administration (FDA) is updating the public about its ongoing safety review of Lantus (insulin glargine) and a possible increased risk of cancer. Lantus is a long-acting modified version of human insulin (insulin analog) used to control blood sugar in patients with Type 1 and Type 2 diabetes.

In July 2009, FDA issued an Early Communication About Safety of Lantus (insulin glargine) to inform the public that it was reviewing four published observational studies, three of which suggested an increased risk of cancer associated with the use of Lantus.1-4 FDA has reviewed the four studies and has determined that the evidence presented in the studies is inconclusive, due to limitations in how the studies were designed and carried out and in the data available for analysis. These limitations prevent our ability to attribute the observed cancer risk to Lantus (see Data Summary below).

FDA has also reviewed results from a five-year randomized clinical trial, Evaluation of Diabetic Retinopathy Progression in Subjects with Type 2 Diabetes Mellitus Treated with Oral Agents Plus Insulin, which compared Lantus to Neutral Protamine Hagedorn (NPH) insulin in individuals with Type 2 diabetes. The results did not show an increased risk of cancer in subjects treated with Lantus compared to those treated with NPH insulin; however, this study was not specifically designed to evaluate cancer outcomes.

FDA is continuing to work with the manufacturer of Lantus and the U.S. Department of Veterans Affairs (VA) to further evaluate the long-term risk, if any, for cancer associated with the use of Lantus.

At this time, FDA has not concluded that Lantus increases the risk of cancer. Our review is ongoing, including review of information from a current clinical trial, and the Agency will update the public when it has additional information. 

  • Healthcare professionals should continue to follow the recommendations in the drug label when prescribing Lantus.
  • Patients should continue taking Lantus unless told otherwise by their healthcare professional.
  • Patients who have concerns about using Lantus should talk to their healthcare professional.

 This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety review of drugs.

 

Additional Information for Patients

  • Do not stop taking your Lantus unless told to do so by your healthcare professional.
  • FDA has not concluded that Lantus increases the risk of cancer. The Agency is continuing to review this safety concern and will update the public when additional information is available.
  • Talk to your healthcare professional if you have concerns about Lantus.
  • Report any side effects from the use of Lantus to the FDA MedWatch program, using the information in the “Contact Us” box at the bottom of the page.

 

Additional Information for Healthcare Professionals

  • FDA has not concluded that Lantus increases the risk of cancer. The Agency is continuing to review this safety concern and will update the public when additional information is available.
  • Follow the recommendations in the drug label when prescribing Lantus.
  • Report adverse events involving Lantus to the FDA MedWatch program using the information in the “Contact Us” box at the bottom of this page.

 

Data Summary

In July 2009, FDA issued an Early Communication About Safety of Lantus (insulin glargine) to inform the public that it was reviewing four published observational studies, three of which suggested an increased risk of cancer associated with the use of Lantus.1-4 FDA has completed its review of the studies and has determined that the evidence presented in these studies is inconclusive due to methodological limitations.

The duration of patient follow-up in all four studies was shorter than what is generally considered necessary to evaluate cancer risk from drug exposure. Also, the four studies provided limited information on patients’ use of insulin products. Additionally, some of these studies did not take into account whether the patients used any anti-diabetic drugs before the study time period or whether there were any changes in how patients used these drugs during the study period. Furthermore, risk factors for cancer, such as smoking, family history of cancer, and obesity, may not have been adequately controlled for in these studies. This prevents our ability to attribute the observed cancer risk solely to Lantus.

In addition to the four published observational studies, FDA has reviewed results from the Evaluation of Diabetic Retinopathy Progression in Subjects with Type 2 Diabetes Mellitus Treated with Oral Agents Plus Insulin trial, which was a five-year, randomized trial comparing Lantus to NPH insulin in individuals with Type 2 diabetes. A post-hoc evaluation (examining the data after the trial concluded for outcomes that were not identified a priori) of the occurrence of cancer was conducted. The safety population consisted of over 500 patients per treatment arm with a median exposure of approximately five years. The overall occurrence of all cancers was 5.8% in the Lantus arm versus 9.3% in the NPH insulin arm. The odds ratio for all cancers was 0.60 (95% Confidence Interval 0.36, 0.99). The results did not support an increased risk of cancer associated with Lantus in comparison to NPH insulin; however, the study was not designed or powered to evaluate cancer outcomes and these outcomes were not verified in medical records or reviewed by cancer experts.

FDA continues to work with the manufacturer of Lantus and other scientists to further evaluate the safety of Lantus. The manufacturer’s ongoing Outcome Reduction with Initial Glargine Intervention (ORIGIN) clinical trial has been amended to adjudicate (have a panel of experts in cancer evaluate) all cases of cancer occurring during the trial. The ORIGIN trial is designed to determine if treatment with Lantus to reduce fasting plasma glucose to 95 mg/dL or less would reduce the incidence of cardiovascular events in patients with pre-diabetes or early diabetes versus standard care. An interim review of the data by an independent data monitoring committee did not show evidence of a signal for increased cancer risk. Results from the ORIGIN trial are expected at the end of 2011.

FDA is aware that the manufacturer plans to conduct three epidemiological studies to further evaluate cancer risk associated with the use of Lantus. Results from the epidemiological studies are expected by the end of June 2011.

FDA is also working with the VA to decide whether to use the VA’s patient database to further evaluate any potential cancer risk with Lantus.

FDA will communicate important new data on this issue when they become available.

 

References 

  1. Hemkens LG, Grouven U, Bender R, Günster C, Gutschmidt S, Selke GW, Sawicki PT. Risk of malignancies in patients with diabetes treated with human insulin or insulin analogues: a cohort study. Diabetologia. 2009;52:1732-44.
  2. Jonasson JM, Ljung R, Talbäck M, Haglund B, Gudbjörnsdòttir S, Steineck G. Insulin glargine use and short-term incidence of malignancies-a population-based follow-up study in Sweden. Diabetologia. 2009;52:1745-54.
  3. Colhoun HM; SDRN Epidemiology Group. Use of insulin glargine and cancer incidence in Scotland: a study from the Scottish Diabetes Research Network Epidemiology Group. Diabetologia. 2009;52:1755-65.
  4. Currie CJ, Poole CD, Gale EA. The influence of glucose-lowering therapies on cancer risk in type 2 diabetes. Diabetologia. 2009;52:1766-77.

Poisonings in Children Under Five Years

Pediatric Poisonings in Children Younger than Five Years Responded to by
Paramedics
Published online: 10 January 2011
Gary M. Vilke, Danielle J. Douglas, Holly Shipp, Barbara Stepanski, Alan Smith,
Leslie Upledger Ray, Edward M. Castillo
DOI: 10.1016/j.jemermed.2010.10.018
Journal of Emergency Medicine, The,

http://www.jem-journal.com/article/S0736-4679%2810%2900911-X/abstract

Severe Sepsis

Accuracy of Microscopic Urine Analysis and Chest Radiography in Patients with
Severe Sepsis and Septic Shock
Published online: 10 January 2011
Roberta Capp, Yuchiao Chang, David F.M. Brown
DOI: 10.1016/j.jemermed.2010.10.017
Journal of Emergency Medicine

 

Link:  http://www.jem-journal.com/article/S0736-4679%2810%2900909-1/abstract

Occupant Injuries and Seat Belt Use Among Adults

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5951a3.htm?s_cid=mm5951a3_e&source=govdelivery

Vital Signs: Nonfatal, Motor Vehicle–Occupant Injuries (2009) and Seat Belt Use (2008) Among Adults — United States

MMWR WeeklyJanuary 7, 2011 / 59(51);1681-1686

 

Key Points 
  • Motor vehicle crashes are the leading cause of death in the United States among persons aged 5–34 years. An estimated 2.3 million injuries among adults were treated in emergency departments in 2009.
  • Seat belt use is the most effective method to reduce the risk of injury or death among adults in a crash.
  • Primary seat belt enforcement laws with vigorous police enforcement are an effective tool to increase seat belt use and reduce death rates.
  • In 2008, overall seat belt use reached a high of 85.0%, indicating it is the social norm in the United States.
  • In 2008, seat belt use was higher in states with primary enforcement laws (88.2%) than in states with secondary enforcement laws (79.2%). If seat belt use in states with secondary enforcement laws had matched that in states with primary enforcement laws, an additional 7.3 million adults would have reported seat belt use in 2008.

Abstract

Background: Motor vehicle crashes are the leading cause of death in the United States among persons aged 5–34 years. Seat belts have been shown to be the most effective method for reducing injuries among adults in the event of a crash.

Methods: CDC used 2009 data from the National Electronic Injury Surveillance System–All Injury Program (NEISS-AIP) to provide U.S. estimates of the number and rate of nonfatal, motor vehicle–occupant injuries treated in emergency departments among adults aged ≥18 years. In addition, CDC used 2008 data from the Behavioral Risk Factor Surveillance System (BRFSS) to estimate the prevalence of self-reported seat belt use among adults in the United States. Seat belt use was examined further by type of state seat belt enforcement law.

Results: In 2009 in the United States, an estimated 2.3 million adult motor vehicle–occupants had nonfatal injuries treated in emergency departments. The nonfatal, motor vehicle–occupant injury rate declined 15.6% from 1,193.8 per 100,000 population in 2001 to 1,007.5 per 100,000 population in 2009. In 2008, self-reported seat belt use was higher in states with primary enforcement laws (88.2%), compared with states with secondary enforcement laws (79.2%). If the secondary law states had achieved 88.2% seat belt use in 2008, an additional 7.3 million adults would have been belted. From 2002 to 2008, self-reported seat belt use increased overall from 80.5% to 85.0%.

Conclusions: Nonfatal, motor vehicle–occupant injuries treated in emergency departments have declined in recent years but still affect a substantial proportion of the adult U.S. population each year. Self-reported belt use increased from 2002 to 2008, and was higher in states with primary enforcement laws compared with states with secondary enforcement laws.

Implications for Public Health Practice: Seat belt use is a proven method to reduce motor vehicle–occupant injuries, and the results of this analysis demonstrate that states with primary enforcement laws have higher prevalence of self-reported seat belt use. To help reduce the number of motor vehicle–occupant injuries, 19 states without primary enforcement laws should consider enacting them.

Ventilator-associated pneumonia in trauma patients

http://www.medwire-news.md/43/90676/Infectious_Disease_News/Prehospital_intubation_cleared_of_raising_pneumonia_risk.html

Timing of Intubation and Ventilator-Associated Pneumonia Following Injury

Heather L. Evans, MD, MS; David H. Zonies, MD, MPH; Keir J. Warner, BS; Eileen M. Bulger, MD; Sam R. Sharar, MD; Ronald V. Maier, MD; Joseph Cuschieri, MD

Arch Surg. 2010;145(11):1041-1046. doi:10.1001/archsurg.2010.239

Abstral (fentanyl) transmucosal tablets

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm239490.htm

FDA PRESS RELEASE

For Immediate Release: Jan 7, 2011
Media Inquiries
: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries
: 888-INFO-FDA

FDA approves opioid analgesic to help cancer patients manage pain
Enrollment in REMS program required for health care professionals

The U.S. Food and Drug Administration today approved Abstral (fentanyl) transmucosal tablets to manage breakthrough pain for adults with cancer.  Fentanyl immediate-release transmucosal medications are administered on the soft surfaces of the mouth (inside of the cheek, gums, tongue), or the nasal passages or throat where they dissolve and are absorbed.

“This is an important step for patients with cancer pain to have options for the treatment of their breakthrough pain,” said John Jenkins, M.D., director of FDA’s Office of New Drugs in the Center for Drug Evaluation and Research.

Abstral is indicated for the management of breakthrough pain in patients with cancer, ages 18 years and older, who already use opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medicine.  Breakthrough pain is pain that comes on suddenly for short periods of time and is not alleviated by a patient’s normal pain management plan. These patients are considered opioid tolerant because of their current opioid medication use.  Only health care professionals skilled in the use of Schedule II opioids to treat pain should prescribe this drug product. 

Abstral is available only through a Risk Evaluation and Mitigation Strategy (REMS) program, which is intended to minimize the risk of misuse, abuse, addiction and overdose.  Under this program, pharmacies, distributors, and health care professionals who prescribe to outpatients are required to enroll in the program to prescribe, dispense and distribute this product.  FDA has standardized key components of the REMS program to facilitate the adoption of a single shared system. These components include the REMS document, the Patient-Prescriber Agreement, and the enrollment form. These components can be used by all sponsors of immediate release transmucosal fentanyl products to develop individual REMS programs  such as the program approved for Abstral.  FDA has also directed the sponsors of this class of products to work together on a single shared system to implement the REMS. 

“This approval is also a significant step toward reducing the burden on the health care system of implementing REMS programs,” added Dr. Jenkins. “When fully implemented, FDA expects that prescribers, pharmacies, and distributors of all immediate release transmucosal fentanyl products will be able to use standardized materials and a single shared system to implement the REMS.”

The safety of Abstral was evaluated in 311 opioid-tolerant cancer patients with breakthrough pain.  Two hundred and seventy of these patients were treated in multiple-dose studies. The duration of therapy for patients in multiple-dose studies ranged from 1-405 days with an average duration of 131 days and with 44 patients treated for at least 12 months.

Common adverse reactions include nausea, constipation, drowsiness and headache. Serious adverse events, including deaths, have been reported in patients with other immediate-release transmucosal fentanyl products. The deaths occurred as a result of improper patient selection and/or improper dosing. 

Consumers and health care professionals are encouraged to report adverse side effects or medication errors from the use of Abstral to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.
Abstral is manufactured by ProStraken Inc., based in Bedminister, N.J.

Obesity: A death-dealing risk factor with H1N1

MedNewsToday

http://www.medicalnewstoday.com/articles/213169.php

Extremely Obese People More Likely To Die From H1N1 Swine Flu

08 Jan 2011   
“Extremely obese individuals, those with a BMI (body mass index) of over 40, have a significantly higher chance of dying from 2009 A(H1N1) swine flu infection compared to other people, researchers revealed in the journal Clinical Infectious Diseases. The scientists gathered data from a public health surveillance database in California and found extreme obesity to be a “powerful risk factor for death”…..”

“A Novel Risk Factor for a Novel Virus: Obesity and 2009 Pandemic Influenza A(H1N1)”                                                                                                                                                                                                                                                                                             Janice K. Louie, Meileen Acosta, Michael C. Samuel, Robert Schechter, Duc J. Vugia, Kathleen Harriman, Bela T. Matyas, and the California Pandemic (H1N1) Working Group
Clin Infect Dis. (2011) doi: 10.1093/cid/ciq152

http://cid.oxfordjournals.org/content/early/2011/01/04/cid.ciq152.full.pdf+html

Flu season not going well in the UK… a precursor for the Colonies?

The Brits are getting nervous about this flu season.  They are experiencing shortages of seasonal influenza vaccine. There aremore cases and deaths.  British health officials are telling docs  that they can use stockpiled monovalent 2009 H1N1 vaccine to immunize high-risk patients.

http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=19760

Citation: Ellis J, Galiano M, Pebody R, Lackenby A, Thompson C, Bermingham A, McLean E, Zhao H, Bolotin S, Dar O, Watson JM, Zambon M. Virological analysis of fatal influenza cases in the United Kingdom during the early wave of influenza in winter 2010/11. Euro Surveill. 2011;16(1):pii=19760.

Available online: http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=19760

Abstract:  “….Clinical influenza activity has been increasing. Severe illness, resulting in hospitalisation and deaths, has occurred in children and young adults and has predominantly been associated with influenza A(H1N1)2009, but also influenza B viruses.” 

On Prescription Drug Abuse

http://www.nytimes.com/2011/01/06/health/06drugs.html?pagewanted=all

NY Times

January 5, 2011
Prescription Drug Abuse Sends More People to the Hospital
By ABBY GOODNOUGH

“The number of emergency room visits resulting from misuse or abuse of prescription drugs has nearly doubled over the last five years, according to new federal data, even as the number of visits because of illicit drugs like cocaine and heroin has barely changed.

The Substance Abuse and Mental Health Services Administration found there were about 1.2 million visits to emergency rooms involving pharmaceutical drugs in 2009, compared with 627,000 in 2004….”

Coughs and Flu Crap

 

Citation: Lindsley WG, Blachere FM, Thewlis RE, Vishnu A, Davis KA, et al. (2010) Measurements of Airborne Influenza Virus in Aerosol Particles from Human Coughs. PLoS ONE 5(11): e15100. doi:10.1371/journal.pone.0015100

 

http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.00

15100

 

CDC: Updated Recommendations for Obstetric Health Care Providers Related to Use of Antiviral Medications in the Treatment and Prevention of Influenza for the 2010-2011 Season

 

http://www.cdc.gov/flu/professionals/antivirals/avrec_ob2011.htm?s_cid=ccu010311_007

Updated Recommendations for Obstetric Health Care Providers Related to Use of Antiviral Medications in the Treatment and Prevention of Influenza for the 2010-2011 Season

December 29, 2010

These recommendations provide guidance for obstetric health care providers in prescribing antiviral medications for treatment and prevention of influenza during the 2010-2011 season. These recommendations are consistent with current recommendations for antiviral treatment from the Advisory Committee on Immunization Practices. In addition, CDC convened a meeting of experts on August 12-13, 2010, to review the evidence and provide input on treatment and prevention of influenza during pregnancy. Experts in the fields of influenza, obstetrics, pediatrics, pharmacy, teratology, maternal-fetal medicine, preventive medicine, public health, emergency response, and others participated in the meeting. Data from the 2009-2010 influenza season showed that women who were treated early with antiviral medications were less likely to be admitted to an intensive care unit and less likely to die (Siston et al., 2010; Louie et al., 2010). In addition, available data suggest that neuraminidase inhibitors (oseltamivir and zanamavir) are not teratogenic (Rasmussen et al., 2009; Tanaka et al., 2009; Greer et al., 2010). These treatment recommendations will be updated as needed.

Treatment

  • Pregnant women are at higher risk for severe complications and death from influenza. Changes in the immune, respiratory, and cardiovascular systems that occur during pregnancy result in pregnant women being more severely affected by certain pathogens, including influenza.
  • Postpartum women, who are in transition to normal immune, cardiac, and respiratory function, should be considered to be at increased risk of influenza-related complications up to 2 weeks postpartum (including following pregnancy loss).
  • Treatment with antiviral medications is recommended for pregnant women or women who are up to 2 weeks postpartum (including following pregnancy loss) with suspected or confirmed influenza and can be taken during any trimester of pregnancy.
  • For treatment of pregnant women or women who are up to 2 weeks postpartum with suspected or confirmed influenza, oseltamivir is currently preferred. The duration of antiviral treatment is 5 days. See Table 1 (below) for dosing information.
  • Hospitalized patients with severe infections (such as those with prolonged infection or who require intensive care unit admission) might require longer treatment courses. Some experts have advocated use of increased (doubled) doses of oseltamivir for some severely ill patients, although there are no published data demonstrating that higher doses are more effective.
  • Oseltamivir and zanamivir are antiviral medications that are FDA approved for treatment of influenza. Pregnancy should not be considered a contraindication to oseltamivir or zanamivir use. These medications are “Pregnancy Category CExternal Web Site Icon ” medications, indicating that no clinical studies have been conducted to assess the safety of these medications for pregnant women. However, the available risk-benefit data indicate that pregnant women with suspected or confirmed influenza should receive prompt antiviral therapy.
  • Treatment should be initiated as early as possible because studies show that treatment initiated early (i.e., within 48 hours of illness onset) is more likely to provide benefit. However, some studies of hospitalized patients with influenza, including an analysis of hospitalized pregnant women, have suggested benefit of antiviral treatment even when treatment was started more than 48 hours after illness onset.
  • Treatment should not wait for laboratory confirmation of influenza because laboratory testing can delay treatment and because a negative rapid test for influenza does not rule out influenza. Pregnant women are considered to be at higher risk of influenza complications by the Advisory Committee on Immunization Practices, and thus, empiric treatment is recommended. Treatment decisions, especially those involving empiric treatments, should be informed by knowledge of influenza activity in the community.
  • At this time, nearly all influenza viruses are susceptible to oseltamivir and zanamivir. However, antiviral treatment regimens might change depending on new antiviral resistance or viral surveillance information.
  • Since rapid access to antiviral medications is important, health care providers who care for pregnant and postpartum (including following pregnancy loss) women should develop methods to ensure that treatment can be started quickly after symptom onset. Actions that will support early treatment initiation include:
    • Informing pregnant and postpartum (including following pregnancy loss) women of signs and symptoms of influenza and the need for early treatment after onset of symptoms. Typical manifestations of influenza include fever, cough, rhinorrhea, sore throat, headache, shortness of breath, and myalgia. Some patients with influenza have vomiting, diarrhea, or conjunctivitis, and some have respiratory symptoms without fever.
    • Ensuring rapid access to telephone consultation and clinical evaluation for pregnant and postpartum (including following pregnancy loss) women
    • Considering empiric treatment of pregnant women and women who are up to 2 weeks postpartum (including following pregnancy loss) based on telephone contact if hospitalization is not indicated and if this will substantially reduce delay before treatment is initiated
  • Fever in pregnant women should be treated because of the risk that it appears to pose to the fetus. Acetaminophen appears to be the best option for treatment of fever during pregnancy.

Chemoprophylaxis

  • Post-exposure antiviral chemoprophylaxis can be considered for pregnant women and women who are up to 2 weeks postpartum (including following pregnancy loss) who have had close contact with someone likely to have been infectious with influenza. Close contact, for the purposes of this document, is defined as having cared for or lived with a person who has confirmed, probable, or suspected influenza, or having been in a setting where there was a high likelihood of contact with respiratory droplets and/or body fluids of such a person, including having talked face-to-face with a person with suspected or confirmed influenza illness.
  • The drug of choice for chemoprophylaxis of pregnant women and women who are up to 2 weeks postpartum (including following pregnancy loss) is less clear. Zanamivir may be the preferable antiviral for chemoprophylaxis of pregnant women because of its limited systemic absorption. However, respiratory complications that may be associated with zanamivir because of its inhaled route of administration need to be considered, especially in women at risk for respiratory problems. For these women, oseltamivir is a reasonable alternative. The duration of antiviral chemoprophylaxis post-exposure is 10 days after the last known exposure. See Table 1 (below) for dosing information.
  • Early treatment is an alternative to chemoprophylaxis for some pregnant and postpartum (including following pregnancy loss) women who have had contact with someone likely to have been infectious with influenza. Clinical judgment is an important factor in treatment decisions. Pregnant women and women who are up to 2 weeks postpartum (including following pregnancy loss) who are given post-exposure chemoprophylaxis should be informed that the chemoprophylaxis lowers but does not eliminate the risk of influenza and that protection stops when the medication course is stopped. Those receiving chemoprophylaxis should be encouraged to seek medical evaluation as soon as they develop a febrile respiratory illness that might indicate influenza.
  • All pregnant women should be counseled about the early signs and symptoms of influenza infection and advised to immediately call for evaluation if clinical signs or symptoms develop while these women are pregnant or are in the first two weeks after delivery or pregnancy loss.

Table 1. Antiviral medication dosing recommendations for treatment or chemoprophylaxis of influenza infection
(Table extracted from IDSA guidelines for seasonal influenza .)
Agent, group Treatment Chemoprophylaxis
Oseltamivir
Adults 75-mg capsule twice daily for 5 days 75-mg capsule once daily for 10 days
Zanamivir
Adults 10 mg (2 inhalations) twice daily for 5 days 10 mg (2 inhalations) once daily for 10 days

References:

Greer LG, Sheffield JS, Rogers VL, Roberts SW, McIntire DD, Wendel GD, Jr. Maternal and neonatal outcomes after antepartum treatment of influenza with antiviral medications. Obstet Gynecol 2010;115:711-6.

Louie JK, Acosta M, Jamieson DJ, Honein MA. Severe 2009 H1N1 influenza in pregnant and postpartum women in California. N Engl J Med 2010;362:27-35.

Rasmussen SA, Jamieson DJ, MacFarlane K, et al. Pandemic influenza and pregnant women: Summary of a meeting of experts. Am J Public Health 2009;99 S248-54.

Siston AM, Rasmussen SA, Honein MA, et al. Pandemic 2009 influenza A(H1N1) virus illness among pregnant women in the United States. JAMA 2010;303:1517-25.

Tanaka T, Nakajima K, Murashima A, Garcia-Bournissen F, Koren G, Ito S. Safety of neuraminidase inhibitors against novel influenza A (H1N1) in pregnant and breastfeeding women. CMAJ 2009;181:55-8.

US: Nonfatal, Motor Vehicle–Occupant Injuries (2009) and Seat Belt Use (2008) Among Adults

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm59e0104a1.htm?s_cid=mm59e0104a1_e&source=govdelivery

Vital Signs: Nonfatal, Motor Vehicle–Occupant Injuries (2009) and Seat Belt Use (2008) Among Adults — United States

Early Release

January 4, 2011 / 59(Early Release);1-6

ABSTRACT

Background: Motor vehicle crashes are the leading cause of death in the United States among persons aged 5–34 years. Seat belts have been shown to be the most effective method for reducing injuries among adults in the event of a crash.

Methods: CDC used 2009 data from the National Electronic Injury Surveillance System–All Injury Program (NEISS-AIP) to provide U.S. estimates of the number and rate of nonfatal, motor vehicle–occupant injuries treated in emergency departments among adults aged ≥18 years. In addition, CDC used 2008 data from the Behavioral Risk Factor Surveillance System (BRFSS) to estimate the prevalence of self-reported seat belt use among adults in the United States. Seat belt use was examined further by type of state seat belt enforcement law.

Results: In 2009 in the United States, an estimated 2.3 million adult motor vehicle–occupants had nonfatal injuries treated in emergency departments. The nonfatal, motor vehicle–occupant injury rate declined 15.6% from 1,193.8 per 100,000 population in 2001 to 1,007.5 per 100,000 population in 2009. In 2008, self-reported seat belt use was higher in states with primary enforcement laws (88.2%), compared with states with secondary enforcement laws (79.2%). If the secondary law states had achieved 88.2% seat belt use in 2008, an additional 7.3 million adults would have been belted. From 2002 to 2008, self-reported seat belt use increased overall from 80.5% to 85.0%.

Conclusions: Nonfatal, motor vehicle–occupant injuries treated in emergency departments have declined in recent years but still affect a substantial proportion of the adult U.S. population each year. Self-reported belt use increased from 2002 to 2008, and was higher in states with primary enforcement laws compared with states with secondary enforcement laws.

Implications for Public Health Practice: Seat belt use is a proven method to reduce motor vehicle–occupant injuries, and the results of this analysis demonstrate that states with primary enforcement laws have higher prevalence of self-reported seat belt use. To help reduce the number of motor vehicle–occupant injuries, 19 states without primary enforcement laws should consider enacting them.

Introduction

In addition to being the leading cause of death among U.S. residents aged 5–34 years, motor vehicle–occupant injuries account for approximately 15% of all nonfatal injuries treated in U.S. emergency departments (1). In 2005, the lifetime costs of fatal and nonfatal motor vehicle–occupant injuries were estimated at approximately $70 billion, including costs for medical care, treatment, rehabilitation, and lost productivity (2). Motor vehicles account for approximately 90% of all trips taken in the United States, and the vast majority of persons killed and injured while traveling are occupants of motor vehicles (3). Seat belts, which reduce the risk for fatal injuries from motor vehicle crashes by approximately 45% and serious injuries by approximately 50% (4), are the most effective intervention for protecting motor vehicle occupants (5). Primary seat belt enforcement laws and enhanced enforcement of such laws have been shown to increase the use of seat belts and reduce death rates (6).

For this report, CDC used 2009 data from NEISS-AIP to provide estimates of the number and rate of nonfatal, motor vehicle–occupant injuries treated in emergency departments among adults aged ≥18 years. CDC also used 2008 BRFSS to analyze state-level information regarding self-reported seat belt use. In addition, trends in motor vehicle–occupant injuries and seat belt use were examined over time.

Methods

NEISS-AIP is a collaborative effort of CDC and the Consumer Product Safety Commission, and an extension of the National Electronic Injury Surveillance System (NEISS), which collects detailed data abstracted from medical records of initial emergency department visits for all types and causes of nonfatal injuries and poisonings treated in the United States. NEISS-AIP data are a nationally representative, stratified probability sample taken annually from approximately 66 hospitals with at least six beds and 24-hour emergency department services.

NEISS-AIP data were accessed via CDC’s Web-based Injury Statistics Query and Reporting System (WISQARS) online database, which provides customized reports of injury data (1). Motor vehicle–occupant injuries among adults aged ≥18 years were examined for the period 2001–2009. Nonfatal injury rates were calculated for adult motor vehicle occupants by age group and sex. Bridged race postcensal population estimates from the U.S. Census Bureau were used to calculate injury rates. All injury rates were age-adjusted to the 2000 standard U.S. population. A weighted linear regression was used to analyze the trend in occupant injury rates over time.

BRFSS is an ongoing, state-based, random-digit–dialed telephone survey that collects self-reported data on health-related behaviors and conditions. Data are collected from noninstitutionalized, civilian adults aged ≥18 years in all 50 states, the District of Columbia (DC), and three territories (Guam, Puerto Rico, and U.S. Virgin Islands). In 2008, the median Council of American Survey Research Organizations (CASRO) response rate among states was 53%.

One question on seat belt use is included periodically on the BRFSS survey of each state. Participants are asked “How often do you use seat belts when you drive or ride in a car? Would you say: always, nearly always, sometimes, seldom, never, or don’t know?” For this analysis, only those who responded “always” were categorized as seat belt users. Data were examined for the most recent years available: 2002, 2006, and 2008. The prevalence of always wearing seat belts in 2008 was stratified by type of state seat belt enforcement law (primary or secondary) and reported by sex, age group, race/ethnicity, education level, household income, and residential area. Primary enforcement laws allow police officers to stop drivers and issue tickets solely because occupants are unbelted. Secondary enforcement laws only allow police officers to issue tickets for seat belt violations if drivers have been stopped for violating some other law. In 2008, 26 states, DC, and the three territories had primary laws, 23 states had secondary laws, and one state (New Hampshire) had no seat belt law (7).* For this analysis, New Hampshire was grouped with the secondary law states. The t-test was used to determine the trend in seat belt use during 2002–2008.

Results

In 2009, an estimated 2,317,000 nonfatal, motor vehicle–occupant injuries occurred among adults in the United States. The motor vehicle–occupant age-adjusted injury rate was highest among persons aged 18–24 years (1,939.2 per 100,000 population), followed by persons aged 25–34 years (1,322.4) (Table 1). From 2001 to 2009, the injury rate declined 15.6% (p<0.001) from 1,193.8 injuries per 100,000 population to 1,007.5 (Figure); this decline represents an estimated 231,000 fewer injuries in 2009 compared with 2001. During the same period, the injury rate also declined for men, from 1,137.5 per 100,000 population in 2001 to 906.6 in 2009 (p<0.001) and for women, from 1,246.9 in 2001 to 1,104.2 in 2009 (p<0.001).

In 2008, the overall prevalence of self-reported seat belt use in the United States was 85.0%, a 5.6% increase from 80.5% in 2002 (p<0.001). Significant increases in seat belt use from 2002 were observed both in states with primary enforcement laws (p<0.001) and states with secondary enforcement laws (p<0.001). In 2008, among states, self-reported seat belt use ranged from 59.2% (North Dakota) to 93.7% (Oregon) (Table 2). In 2008, seven states and territories had ≥90% prevalence of seat belt use (Table 2). After Oregon, the highest prevalence of self-reported seat belt use was in California (93.2%), Washington (92.0%), Hawaii (91.4%), Texas (91.1%), Puerto Rico (91.1%), and New Jersey (90.3%) (Table 2). Overall, the prevalence of self-reported seat belt use in states with primary enforcement laws was 88.2%, compared with 79.2% for states with secondary enforcement laws (Table 2). If the states with secondary laws had achieved 88.2% seat belt use in 2008, an additional 7,345,000 adults would have been belted. Although the states with secondary laws represented 35% of the total U.S. adult population, 49% of unbelted adults lived in these states.

Persons in certain sociodemographic categories were less likely to report seat belt use than others, such as men (compared with women), persons aged 18–24 years (compared with all other age groups), residents of rural areas (compared with urban or suburban areas), and whites, blacks, and American Indian/Alaska Natives (compared with Hispanics or Asians/Hawaiian or Pacific Islanders) (Table 3). However, for every sociodemographic category examined, prevalence of self-reported seat belt use was higher among residents of states with primary enforcement laws, compared with residents of states with secondary enforcement laws (Table 3).

Conclusions and Comment

Self-reported seat belt use has continued to increase, reaching a high of 85.0% in 2008, until it is now the social norm among residents of the United States. In contrast, in 1982, only 11% of U.S. residents reported seat belt use (8), and the first state law mandating seat belt use was not passed until 1984. Despite the upward trend, the overall prevalence of self-reported seat belt use among residents of states with secondary enforcement laws trails that among residents of states with primary enforcement laws (79.2% versus 88.2%). If the overall prevalence of seat belt use in states with secondary enforcement laws had matched the higher prevalence in states with primary enforcement laws, an additional 7.3 million adults would have reported seat belt use in 2008. Further, a disproportionate number of adults who did not report seat belt use (49%) lived in states with secondary enforcement laws, which made up 35% of the total U.S. adult population. The higher levels of seat belt use associated with primary enforcement laws have been demonstrated to reduce serious injuries and deaths (6).

This analysis shows that persons in certain sociodemographic categories are less likely than others to use seat belts (e.g., men, young adults, residents of rural areas, and certain racial/ethnic populations). However, even among these persons, self-reported seat belt use was higher among those in states with primary laws. This finding supports previous research that showed that primary enforcement laws can increase seat belt use, even among those persons less likely to use seat belts and more likely to be killed in motor vehicle crashes (9).

From 2001 to 2009, a period during which 14 additional states passed primary seat belt laws, the nonfatal, motor vehicle–occupant injury rate declined. Motor vehicle–occupant fatality rates also declined during this period (10). The results of this report indicate that rates of nonfatal injury declined with age, a finding consistent with earlier findings that drivers aged 16–24 years had the highest rates of crash-related injury and death (10). This report found no significant difference in the nonfatal, motor vehicle–occupant injury rates for men and women. However, crash-related injuries sustained by men tend to be more severe than those for women, leading to a higher case-fatality rate for men (11).

Increases in seat belt use likely have contributed to the observed declines in motor vehicle–occupant injuries. Seat belt use reduces the likelihood of serious injury in a crash by approximately 50% (4). The National Highway Traffic Safety Administration (NHTSA) investigated the long-term trend of declining nonfatal traffic injuries and found that increases in seat belt use were a major factor in the reduction in injuries (12). Other contributing factors included declines in alcohol-impaired driving and improvements in vehicle safety (e.g., air bags and electronic stability control) (12). NHTSA estimates that, in 2009, nearly 450 additional lives would have been saved, 12,000 nonfatal injuries prevented, and $1.6 billion in societal costs saved if all states had primary seat belt enforcement laws (NHTSA, 2009, unpublished data). Many high-income countries in Europe have achieved high levels of seat belt use with primary enforcement laws that cover all vehicle occupants. Front-seat estimates of seat belt use are >90% in France (98%), Sweden (96%), Germany (95%), Netherlands (94%), Norway (93%), and United Kingdom (91%)] (13). Notably, the traffic fatality rate per 100,000 population in the United States is nearly double that of 21 selected European high-income countries (13).

Primary enforcement laws are strongly recommended by the U.S. Task Force on Community Preventive Services to increase seat belt use (6). Other components of seat belt laws also can increase seat belt use. Enhanced enforcement of seat belt laws has been shown to increase seat belt use and reduce injuries and fatalities (6). In addition, NHTSA has estimated that the prevalence of seat belt use in rear seats is nearly 20 percentage points higher in states with laws requiring belt use in all seating positions versus states with laws requiring belt use only in the front seating positions (14).

The findings in this report are subject to at least six limitations. First, NEISS-AIP provides data at the national level but prevents examination of injury estimates by state. The injury estimates reported likely are underestimates of all nonfatal motor vehicle–occupant injuries because NEISS-AIP does not include physician offices, clinics, urgent-care facilities, or any medical facilities other than hospital emergency departments. Additionally, NEISS-AIP does not collect factors that might relate to the injuries, such as seating position, seat belt use, air bag deployment, or whether injuries occurred in states with primary or secondary enforcement laws. Second, 2008 BRFSS was a landline telephone survey, and as such, excluded a small percentage of households with no telephone and approximately 15% of households with wireless telephones only. Third, the BRFSS response rate was only 53%. Fourth, the BRFSS data are self-reported; however, a recent evaluation of self-reported data on seat belt use found little evidence of overestimation of use because of social desirability bias (15). Fifth, the analysis did not consider other components of enforcement laws that might affect seat belt use (e.g., amount of fine, whether all occupants or only those in the front seat are covered, and the length of time law has been in effect). Finally, the data presented from both surveillance systems are cross-sectional and cannot be used to assess causality regarding seat belt enforcement laws, seat belt use, and nonfatal injuries.

To reduce the number of crash-related injuries, all motor vehicle occupants should wear seat belts (or age-appropriate and size-appropriate restraints for children) on every trip. Although primary enforcement laws are a proven strategy for increasing seat belt use and reducing the number of injuries, as of January 2011, 19 states still do not have such laws in effect. States should consider enacting primary enforcement seat belt laws that are vigorously enforced and that cover all motor vehicle occupants of appropriate age and size, regardless of seating position in the vehicle (6,14).

Reported by

LF Beck, MPH, BA West, MPH, Div of Unintentional Injury Prevention, National Center for Injury Prevention and Control, CDC.

 

References

  1. CDC. WISQARS (Web-based Injury Statistics Query and Reporting System). Atlanta, GA: US Department of Health and Human Services, CDC; 2010. Available at http://www.cdc.gov/injury/wisqars. Accessed October 12, 2010.
  2. Naumann RB, Dellinger AM, Zaloshnja E, Lawrence BA, Miller TR. Incidence and total lifetime costs of motor vehicle-related fatal and nonfatal injury by road user type, United States, 2005. Traffic Inj Prev 2010;11:353–60.
  3. Beck LF, Dellinger AM, O’Neil ME. Motor vehicle crash injury rates by mode of travel, United States: using exposure-based methods to quantify differences. Am J Epidemiol 2007;166:212–8.
  4. National Highway Traffic Safety Administration. Final regulatory impact analysis amendment to Federal Motor Vehicle Safety Standard 208. Passenger car front seat occupant protection. Washington, DC: US Department of Transportation, National Highway Traffic Safety Administration; 1984. Publication no. DOT-HS-806-572. Available at http://www-nrd.nhtsa.dot.gov/pubs/806572.pdf Adobe PDF fileExternal Web Site Icon. Accessed December 13, 2010.
  5. National Highway Traffic Safety Administration. Lives saved in 2009 by restraint use and minimum-drinking-age laws. Washington, DC: US Department of Transportation, National Highway Traffic Safety Administration; 2010. Publication no. DOT-HS-811-383. Available at http://www-nrd.nhtsa.dot.gov/pubs/811383.pdf Adobe PDF fileExternal Web Site Icon. Accessed December 13, 2010.
  6. Dinh-Zarr TB, Sleet DA, Shults RA, et al. Reviews of evidence regarding interventions to increase the use of safety belts. Am J Prev Med 2001;21(4 Suppl):48–65.
  7. Insurance Institute for Highway Safety. Safety belt use laws. Arlington, VA: Insurance Institute for Highway Safety; 2010. Available at http://www.iihs.org/laws/safetybeltuse.aspxExternal Web Site Icon. Accessed December 13, 2010.
  8. Williams AF, Wells JK. The role of enforcement programs in increasing seat belt use. J Safety Res 2004;35:175–80.
  9. Beck LF, Shults RA, Mack K, Ryan G. Associations between sociodemographics and safety belt use in states with and without primary enforcement laws. Am J Public Health 2007;97:1619–24.
  10. National Highway Traffic Safety Administration. Traffic safety facts 2008. Washington, DC: US Department of Transportation, National Highway Traffic Safety Administration; 2009. Publication no. DOT-HS-811-170. Available at http://www-nrd.nhtsa.dot.gov/pubs/811170.pdf Adobe PDF fileExternal Web Site Icon. Accessed December 13, 2010.
  11. CDC. Surveillance for fatal and nonfatal injuries—United States, 2001. MMWR 2004;53(No. SS-7).
  12. National Highway Traffic Safety Administration. Trends in non-fatal traffic injuries: 1996–2005. Washington, DC: US Department of Transportation, National Highway Traffic Safety Administration; 2008. Publication no. DOT-HS-810-944. Available at http://www-nrd.nhtsa.dot.gov/pubs/810944.pdf Adobe PDF fileExternal Web Site Icon. Accessed December 13, 2010.
  13. World Health Organization. Global status report on road safety: time for action. Geneva: World Health Organization, 2009. Available at: http://www.who.int/violence_injury_prevention/road_safety_status/2009External Web Site Icon.
  14. National Highway Traffic Safety Administration. Seat belt use in rear seats in 2008. Washington, DC: US Department of Transportation, National Highway Traffic Safety Administration; 2009. Publication no. DOT-HS-811-133. Available at http://www-nrd.nhtsa.dot.gov/pubs/811133.pdf Adobe PDF fileExternal Web Site Icon. Accessed December 13, 2010.
  15. Ibrahimova A. Have self-reported and observed seatbelt use in the United States converged? Presented at the 59th Annual Epidemic Intelligence Service Conference, April 19–23, 2010, Atlanta, GA.

* Arkansas, Florida, Kansas, Minnesota, and Wisconsin subsequently passed primary enforcement laws in 2009 or 2010.