The 2009 influenza pandemic (flu) has created a new framework of acts and regulations to respond the World Health Organization’s (WHO) phase 6 pandemic alert. Governmentally imposed employment disruptions resulting from regulatory work disruptions to prevent the spread of disease maybe massive. While workers’ compensation was envisioned as a summary and remedial social insurance program, the challenges facing the workers’ compensation system to deliver benefits as promised may be seriously burdened.
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Showing posts sorted by relevance for query flu. Sort by date Show all posts
Showing posts sorted by relevance for query flu. Sort by date Show all posts
Tuesday, September 15, 2009
The Urgent Need for Workers Compensation Flu Pandemic Planning
Wednesday, October 28, 2009
Latex Allergy Adverse Reaction Caused by Swine Flu Shot
Just as health care workers and first responders have started to line up for H1N1 flu shots, an adverse reaction to latex has been reported. This development adds further to to the compensable risks resulting from adverse reactions to the vaccine.
Latex allergy claims have long been held compensable in workers' compensation courts throughout the country. The original claims arose out of exposure to latex protein in gloves that came into use as a result of the AIDS epidemic.
A case of latex allergy reaction has been reported in Australia during a vaccination program. While the vaccine and the vial are supposedly latex free, the packing material may not be, and that may have trigger the reaction. One in 100 people are thought to have an allergy to latex.
Reactions to latex may be mild or transitory or may be a permanent sensitization causing hives, shortness of breath, total disability and possible death.
For more articles on Workers' Compensation and the Flu Pandemic click here.
To read more about compensable latex allergy claims click here.
Latex allergy claims have long been held compensable in workers' compensation courts throughout the country. The original claims arose out of exposure to latex protein in gloves that came into use as a result of the AIDS epidemic.
A case of latex allergy reaction has been reported in Australia during a vaccination program. While the vaccine and the vial are supposedly latex free, the packing material may not be, and that may have trigger the reaction. One in 100 people are thought to have an allergy to latex.
Reactions to latex may be mild or transitory or may be a permanent sensitization causing hives, shortness of breath, total disability and possible death.
For more articles on Workers' Compensation and the Flu Pandemic click here.
To read more about compensable latex allergy claims click here.
Thursday, October 29, 2009
NIOSH: H1N1 Flu Is A Serious Risk to Healthcare Workers
The National Institute for Occupational Safety and Health (NIOSH) has declared that 2009 H1N1 Influenza poses a serious risk for healthcare personnel. With at least 4 deaths of nurses being reported in the media, NIOSH has stepped up its efforts to gather and analyze the prevalence of illness and fatalities among health workers.
"Healthcare personnel are at increased risk of occupational exposure to the 2009 H1N1 virus based on their likelihood for encountering patients with 2009 H1N1 illness. In contrast to seasonal influenza virus, 2009 H1N1 influenza virus has caused a greater relative burden of disease in younger people, which includes those in the age range of most healthcare personnel. For some healthcare personnel, this higher risk of exposure and illness may be compounded by the presence of underlying illness which places them at higher risk of serious flu complications, such as asthma, diabetes, or neuromuscular disease. Of particular concern to the healthcare workforce, which is largely female, is the fact that pregnant women are among those groups considered to be at higher risk of severe infection from 2009 H1N1."
Wednesday, July 14, 2010
Comp Maybe Going Viral in Florida Over Dengue Fever
The Workers' Compensation in Florida may be in for yet another assault of claims as dengue virus rages from Ket West spreading north. The Centers for Disease Control has now issued yet another report and alert concerning this wide spread viral condition.
Viruses have, historically, been a problematic challenge to the Workers' Compensation systems. Last flu season the government Federalized the flu compensation program. As this virus spreads, especially with the challenge of the Gulf Oil spill on the compensation system, the State of Florida will need to gear up to operationalize a response.
An estimated 5 percent of the Key West, Fla., population—over 1,000 people—showed evidence of recent exposure to dengue virus in 2009, according to a report from the Centers for Disease Control and Prevention (CDC) and the Florida Department of Health.
After three initial locally acquired cases of dengue were reported in 2009, scientists from the CDC and the Florida Department of Health conducted a study to estimate the potential exposure of the Key West population to dengue virus.
Dengue is the most common virus transmitted by mosquitoes in the world. It causes an estimated 50 million-100 million infections and 25,000 deaths each year. From 1946 to 1980, no cases of dengue acquired in the continental United States were reported, and there has not been an outbreak in Florida since 1934.
"We're concerned that if dengue gains a foothold in Key West, it will travel to other southern cities where the mosquito that transmits dengue is present, like Miami," said Harold Margolis, chief of the dengue branch at CDC. "The mosquito that transmits dengue likes to bite in and around houses, during the day and at night when the lights are on. To protect you and your family, CDC recommends using repellent on your skin while indoors or out. And when possible, wear long sleeves and pants for additional protection."
Since 1980, a few locally acquired U.S. cases have been confirmed along the Texas-Mexico border, which coincided with large outbreaks in neighboring Mexican cities. In recent years, there has been an increase in epidemic dengue in the tropics and subtropics, including Puerto Rico.
"These cases represent the reemergence of dengue fever in Florida and elsewhere in the United States after 75 years," Margolis said. "These people had not travelled outside of Florida, so we need to determine if these cases are an isolated occurrence or if dengue has once again become endemic in the continental United States."
Click here for more information on how Jon L Gelman can assist you in a claim for workers' Compensation claim benefits. You may e-mail Jon Gelman or call 1-973-696-7900.
Thursday, May 7, 2009
OSHA Head Announces Strategy To Protect American Workers From Flu Pandemic
Testifying before the US Congress, Jordan Barab, Acting Assistant Secretary for Occupational Safety and Health (OSHA), declared that the agency had a strategy for protecting American workers. He declared that, "The full range of OSHA’s training, education, enforcement, and public outreach programs will be used to help employers and workers protect themselves at work."
Barab further stated, " ....addressing an influenza pandemic that threatens the workplaces of this nation, we are confronting an unprecedented hazard. In OSHA’s 38-year history, America has never experienced a flu pandemic. However, I would characterize this situation for the workforce just as the President has described it for the nation: “Cause for deep concern, but not panic.” I am very confident in the expertise of OSHA’s medical, scientific, compliance assistance and enforcement personnel. OSHA is prepared to address this threat and we will protect our workforce. I will keep you informed about OSHA efforts to protect America’s working men and women from pandemic flu exposure."
Barab further stated, " ....addressing an influenza pandemic that threatens the workplaces of this nation, we are confronting an unprecedented hazard. In OSHA’s 38-year history, America has never experienced a flu pandemic. However, I would characterize this situation for the workforce just as the President has described it for the nation: “Cause for deep concern, but not panic.” I am very confident in the expertise of OSHA’s medical, scientific, compliance assistance and enforcement personnel. OSHA is prepared to address this threat and we will protect our workforce. I will keep you informed about OSHA efforts to protect America’s working men and women from pandemic flu exposure."
Friday, September 19, 2014
Definitions of health care personnel groups for National Healthcare Safety Network reporting — United States, 2013–14 influenza season
The Advisory Committee on Immunization Practices recommends annual influenza vaccination for all health care personnel (HCP) to reduce influenza-related morbidity and mortality in health care settings. What is added by this report? Nationally, 81.8% of HCP included in National Healthcare Safety Network data were reported as receiving influenza vaccination during the 2013–14 influenza season. Reported proportion of HCP vaccinated was highest among employees (86.1%) and... |
* The American Hospital Association defines community hospitals as all nonfederal, short-term general, and other special hospitals (including obstetrics and gynecology; eye, ear, nose, and throat; rehabilitation; orthopedic; and other individually described specialty services) accessible by the general public. † Data for the 2012–13 season will not be published by CDC or CMS because reporting was required beginning January 1, 2013; therefore, reported data for 2012–13 might not cover the entire influenza season. § Estimates of influenza vaccination coverage among health care personnel working in settings other than acute care hospitals can be obtained for selected states via the optional industry and occupation module of the Behavioral Risk Factor Surveillance System (BRFSS). This module was implemented in the 2013 BRFSS survey; module questions are available at http://www.cdc.gov/brfss/questionnaires/pdf-ques/2013%20brfss_english.pdf. What is already known on this topic? |
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- The Flu Is One Gift That We Don't Have To Keep On Giving For People With Cancer (workers-compensation.blogspot.com)
- US data show higher flu vaccine uptake in kids, adults, health workers (workers-compensation.blogspot.com)
- Fatal Meningococcal Disease in a Laboratory Worker - California, 2012 (workers-compensation.blogspot.com)
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Monday, November 16, 2009
Sick Leave Pay Law For H1N1 Advances
US Senator Chris Dodd (D-CT) has announced that he is preparing legislation to pay sick workers 7 days of sick leave for H1N1 flu. While workers' compensation benefits may be paid to disabled H1N1 flu workers, the threat of delay and denial has created an emergency that Senator Dodd indicates requires immediate Congressional attention.
“This isn’t just a workers’ rights issue – it’s a public health emergency. Families shouldn’t have to choose between staying healthy and making ends meet,” said Dodd. “But if staying home means you don’t get paid, that’s an impossibility, especially for families struggling to make ends meet in this tough economy.”
“This isn’t just a workers’ rights issue – it’s a public health emergency. Families shouldn’t have to choose between staying healthy and making ends meet,” said Dodd. “But if staying home means you don’t get paid, that’s an impossibility, especially for families struggling to make ends meet in this tough economy.”
“Workers should have paid sick leave as a matter of basic fairness,” Dodd continued. “But now sick leave is a matter of keeping Americans safe from this pandemic – and from the next one, whatever it may be.”
He said, "It’s a matter of fairness for workers. It’s a matter of safety."
The CDC reports that H1N1 flu is now widespread in 48 states and may have infected as many as 5.7 million Americans. Fatalities amount to 672 Americans, which includes 129 children.
Wednesday, May 6, 2009
California Workers Compensation Fund Alerts Employers and Employees as to Flu
The California Workers' Compensation Fund has taken the initiative of alerting employers and employees as to preventative measures that should be taken to prevent the spread of Swine Flu.
"To protect California workers and businesses, State Fund advises employers to educate their employees about swine flu facts, symptoms, and preventative measures and to prepare their business operations should a pandemic outbreak significantly reduce their workforce or disrupt their business operation. "
As of today there are 403 reported cases and one death according to the CDC. Numbers are expected to rise as testing has now been shifted from the CDC to the States. California has 49 reported cases.
The novel influenza outbreak (H1N1) has given rise to concern on the impact what a pandemic would cause. The Department of Homeland Security has posted information that workers' compensation programs would probably become involved in responding to the emergency. NIOSH has issued an alert concerning the impact upon psychological and social workers comparing a potential pandemic to the 911 tragedy.
US Congress to Hold Hearing on Helping Schools and Workplaces Prepare For Flu Virus
Taking urgent actions in light of the threat of a pandemic, The Hon. George Miller, Chairman of the Committee on Education and Labor has scheduled a hearing this week.
On Thursday, May 7, the Committee will hold a hearing to examine how federal agencies can help child care, schools, colleges and workplaces prepare for the H1N1 flu virus and future pandemics. The hearing will also provide an update on how schools and workplaces are being affected by and responding to the current outbreak.
WHAT: Hearing on “Ensuring Preparedness Against the Flu Virus at School and Work"
WHO:
Jordan Barab, Acting Assistant Secretary, Occupational Safety and Health Administration, Washington, DC
Ann Brockhaus, Occupational Safety and Health Consultant, ORC Worldwide, Washington, DC
Jack O'Connell, Superintendent of Public Instruction, California Department of Education, Sacramento, CA
Miguel Garcia, Registered Nurse and member, American Federation of State, County and Municipal Employees, Los Angeles, CA
Bill Modzeleski, Associate Assistant Deputy Secretary, Office of Safe and Drug-Free Schools, Department of Education, Washington, DC
Dr. Anne Schuchat, Deputy Director for Science and Program (Interim), Centers for Disease Control, Atlanta, GA
WHEN: Thursday, May 7, 2009 10:00 a.m. ET
Please check the Committee schedule for potential updates »
WHERE: House Education and Labor Committee Hearing Room 2175 Rayburn House Office Building Washington, D.C.
On Thursday, May 7, the Committee will hold a hearing to examine how federal agencies can help child care, schools, colleges and workplaces prepare for the H1N1 flu virus and future pandemics. The hearing will also provide an update on how schools and workplaces are being affected by and responding to the current outbreak.
WHAT: Hearing on “Ensuring Preparedness Against the Flu Virus at School and Work"
WHO:
Jordan Barab, Acting Assistant Secretary, Occupational Safety and Health Administration, Washington, DC
Ann Brockhaus, Occupational Safety and Health Consultant, ORC Worldwide, Washington, DC
Jack O'Connell, Superintendent of Public Instruction, California Department of Education, Sacramento, CA
Miguel Garcia, Registered Nurse and member, American Federation of State, County and Municipal Employees, Los Angeles, CA
Bill Modzeleski, Associate Assistant Deputy Secretary, Office of Safe and Drug-Free Schools, Department of Education, Washington, DC
Dr. Anne Schuchat, Deputy Director for Science and Program (Interim), Centers for Disease Control, Atlanta, GA
WHEN: Thursday, May 7, 2009 10:00 a.m. ET
Please check the Committee schedule for potential updates »
WHERE: House Education and Labor Committee Hearing Room 2175 Rayburn House Office Building Washington, D.C.
Wednesday, October 14, 2009
CDC Issues H1N1 Flu Guidance to Healthcare Personnel-"stay home"
In an urgent need to protect healthcare workers from H1N1 Flu, the today CDC has issued guidance on infection control measures to prevent transmission of 2009 H1N1 influenza in healthcare facilities. The CDC continues to recommend that healthcare workers take time away from work if they are ill. The issue unanswered is whether workers' compensation insurance will pay temporary disability benefits for the absence?
The CDC has defined healthcare personnel as, "....For the purposes of this guidance, healthcare personnel are defined as all persons whose occupational activities involve contact with patients or contaminated material in a healthcare, home healthcare, or clinical laboratory setting. Healthcare personnel are engaged in a range of occupations, many of which include patient contact even though they do not involve direct provision of patient care, such as dietary and housekeeping services. This guidance applies to healthcare personnel working in the following settings: acute care hospitals, nursing homes, skilled nursing facilities, physician’s offices, urgent care centers, outpatient clinics, and home healthcare agencies. It also includes those working in clinical settings within non-healthcare institutions, such as school nurses or personnel staffing clinics in correctional facilities. The term “healthcare personnel” includes not only employees of the organization or agency, but also contractors, clinicians, volunteers, students, trainees, clergy, and others who may come in contact with patients."
- Instructed not to report to work, or if at work, to promptly notify their supervisor and infection control personnel/occupational health.
- Excluded from work for at least 24 hours after they no longer have a fever, without the use of fever-reducing medicines.
Healthcare personnel who develop a fever and respiratory symptoms should be:
For more articles on Workers' Compensation and the Flu Pandemic click here.
Friday, July 10, 2015
FDA Strengthens NSAIDs Warnings: Chance of Heart Attack & Stroke
The U.S. Food and Drug Administration (FDA) is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke.
Based on the FDA's comprehensive review of new safety information, it is requiring updates to the drug labels of all prescription NSAIDs. As is the case with current prescription NSAID labels, the Drug Facts labels of over-the-counter (OTC) non-aspirin NSAIDs already contain information on heart attack and stroke risk. The FDA will also request updates to the OTC non-aspirin NSAID Drug Facts labels.
Patients taking NSAIDs should seek medical attention immediately if they experience symptoms such as chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech.
NSAIDs are widely used to treat pain and fever from many different long- and short-term medical conditions such as arthritis, menstrual cramps, headaches, colds, and the flu. NSAIDs are available by prescription and OTC. Examples of NSAIDs include ibuprofen, naproxen, diclofenac, and celecoxib (see Table 1 for a list of NSAIDs).
The risk of heart attack and stroke with NSAIDs, either of which can lead to death, was first described in 2005 in the Boxed Warning and Warnings and Precautions sections of the prescription drug labels. Since then, we have reviewed a variety of new safety information on prescription and OTC NSAIDs, including observational studies,1 a large combined analysis of clinical trials,2 and other scientific publications.1 These studies were also discussed at a joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee held on February 10-11, 2014.
Based on the FDA's review and the advisory committees’ recommendations, the prescription NSAID labels will be revised to reflect the following information:
It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.
NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.
In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline.
Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.
There is an increased risk of heart failure with NSAID use.
In addition, the format and language contained throughout the labels of prescription NSAIDs will be updated to reflect the newest information available about the NSAID class.
Patients and health care professionals should remain alert for heart-related side effects the
entire time that NSAIDs are being taken. The FDA urges you to report side effects involving
NSAIDs to the FDA MedWatch program, using the information in the “Contact FDA”
box at the bottom of the page.
Facts about non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs)
• NSAIDs are a class of medicines available by prescription and over-the-counter
(OTC). They are some of the most commonly used pain medicines.
• NSAIDs are used to treat pain and fever from medical conditions such as arthritis,
menstrual cramps, headaches, colds, and the flu.
• Examples of NSAIDs include ibuprofen, naproxen, diclofenac, and celecoxib.
See Table 1 for a list of non-aspirin NSAIDs.
Additional Information for Patients and Consumers
• Non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance
of a heart attack or stroke, either of which can lead to death. There are a large
number of studies that support this finding, with varying estimates of how much
the risk is increased, depending on the drugs and the doses studied. These serious
side effects can occur as early as the first weeks of using an NSAID and the risk
may increase the longer you are taking an NSAID.
• The risk appears greater at higher doses; use the lowest effective amount for the
shortest possible time.
• Seek medical attention immediately if you experience symptoms such as:
• Chest pain
• Shortness of breath or trouble breathing
• Sudden weakness or numbness in one part or side of the body
• Sudden slurred speech
• Many medicines contain NSAIDs, including those used for colds, flu, and sleep,
so it is important to read the labels and avoid taking multiple medicines that
contain NSAIDs.
• Patients who take low-dose aspirin for protection against heart attack and stroke
should know that some NSAIDs, including those in over-the-counter (OTC)
products such as ibuprofen and naproxen, can interfere with that protective effect.
• Read the patient Medication Guide you receive with your NSAID prescription. It
explains the risks associated with the use of the medicine. You may access
Medication Guides by clicking on this link.
• Read the Drug Facts label before taking an OTC NSAID. Talk to your health care
professional or pharmacist if you have questions or concerns about NSAIDs or
which medicines contain them.
• Report side effects from NSAIDs to the FDA MedWatch program, using the
information in the "Contact FDA" box at the bottom of this page.
Additional Information for Health Care Professionals
• Non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased
risk of serious cardiovascular thrombotic events, including myocardial infarction
and stroke, either of which can be fatal. There are a large number of studies that
support this finding, with varying estimates of how much the risk is increased.
Estimates of increased risk range from 10 percent to 50 percent or more,
depending on the drugs and the doses studied. This risk may occur as early as the
first weeks of treatment and may increase with duration of use.
• Remain alert for the development of cardiovascular adverse events throughout the
patient’s entire treatment course, even in the absence of previous cardiovascular
symptoms.
• Inform patients to seek medical attention immediately if they experience
symptoms of heart attack or stroke such as chest pain, shortness of breath or
trouble breathing, sudden weakness or numbness in one part or side of the body,
or sudden slurred speech.
• Encourage patients to read the Medication Guide for prescription NSAIDs and the
Drug Facts label for over-the-counter (OTC) NSAIDs.
• Based on available data, it is unclear whether the risk for cardiovascular
thrombotic events is similar for all non-aspirin NSAIDs.
• The increase in cardiovascular thrombotic risk has been observed most
consistently at higher doses.
• The relative increase in serious cardiovascular thrombotic events over baseline
conferred by NSAID use appears to be similar in those with and without known
cardiovascular disease or risk factors for cardiovascular disease. However,
patients with known cardiovascular disease or risk factors had a higher absolute
incidence of serious cardiovascular thrombotic events due to their increased
baseline rate.
• To minimize the risk for an adverse cardiovascular event in patients treated with
an NSAID, prescribe the lowest effective dose for the shortest duration possible.
• Some NSAIDs, including those in OTC products such as ibuprofen and naproxen,
can interfere with the antiplatelet action of low dose aspirin used for
cardioprotection by blocking aspirin’s irreversible COX-1 inhibition.
• Report adverse events involving NSAIDs to the FDA MedWatch program, using
the information in the "Contact FDA" box at the bottom of this page.
Data Summary
FDA reviewed a meta-analysis of randomized clinical trials of cardiovascular and upper
gastrointestinal events with non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs),
conducted by the Coxib and traditional NSAID Trialists’ (CNT) Collaboration of the
Clinical Trial Service and Epidemiological Studies Units at Oxford University.2
We also reviewed observational studies and other scientific publications in the medical literature.1
The findings of these studies were discussed at a joint meeting of the Arthritis Advisory
Committee and Drug Safety and Risk Management Advisory Committee held on
February 10-11, 2014 (for complete safety reviews, background information, and minutes
of this meeting, click here).
Based on the FDA's comprehensive review and the recommendations from the advisory committees, we are requiring label changes to reflect the following conclusions:
• A large number of studies support the finding that NSAIDs cause an increased
risk of serious cardiovascular thrombotic events, with varying estimates of how
much the risk is increased. Estimates of increased relative risk range from 10
percent to 50 percent or more, depending on the drugs and the doses studied.
• Several observational studies found a significant cardiovascular risk within days
to weeks of NSAID initiation. Some data also showed a higher risk with longer
NSAID treatment.
• There are observational data indicating that the thrombotic cardiovascular risk
from NSAID use is dose-related. There is also some evidence of this doseresponse
effect from clinical trials of celecoxib.
• Some observational studies and the CNT meta-analysis suggested that naproxen
may have a lower risk for cardiovascular thrombotic events compared to the other
NSAIDs; however, the observational studies and the indirect comparisons used in
the meta-analysis to assess the risk of the nonselective NSAIDs have limitations
that affect their interpretability. The variability in patients’ risk factors,
comorbidities, concomitant medications and drug interactions, doses being used,
duration of treatment, etc., also need to be taken into consideration to make valid
comparisons. Importantly, these studies were not designed to demonstrate
superior safety of one NSAID compared to another.
• There is evidence of an increased cardiovascular risk from NSAID use by
apparently healthy patients. Data from the CNT meta-analysis, individual
randomized controlled trials, and observational studies showed that the relative
increase in cardiovascular thrombotic events over baseline conferred by NSAID
use appears to be similar in those with and without known cardiovascular disease
or risk factors for cardiovascular disease. However, patients with known
cardiovascular disease or risk factors had a higher absolute incidence of excess
cardiovascular thrombotic events due to their increased baseline rate.
• The CNT meta-analysis demonstrated an approximately two-fold increase in
hospitalizations for heart failure with use of both COX-2 selective and
nonselective NSAIDs. In a Danish National Registry study of patients with heart
failure, NSAID use increased the risk of myocardial infarction, hospitalization for
heart failure, and death.
The Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen
or Naproxen (PRECISION) trial, is a large, ongoing randomized safety trial comparing
cardiovascular event rates among patients with high cardiovascular risk who are
randomized to celecoxib, naproxen, or ibuprofen. This trial was also discussed at the
February 2014 Advisory Committee meeting and is expected to provide additional safety
information.
Table 1. List of non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs)
Generic name Brand name(s)
References
1. Food and Drug Administration [Internet]. Silver Spring, MD. FDA Briefing
Information for the February 10-11, 2014 Joint Meeting of the Arthritis Advisory
Committee and Drug Safety and Risk Management Advisory Committee. Available
from:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM383180.pdf. Accessed December 23, 2014.
Based on the FDA's comprehensive review of new safety information, it is requiring updates to the drug labels of all prescription NSAIDs. As is the case with current prescription NSAID labels, the Drug Facts labels of over-the-counter (OTC) non-aspirin NSAIDs already contain information on heart attack and stroke risk. The FDA will also request updates to the OTC non-aspirin NSAID Drug Facts labels.
Patients taking NSAIDs should seek medical attention immediately if they experience symptoms such as chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech.
NSAIDs are widely used to treat pain and fever from many different long- and short-term medical conditions such as arthritis, menstrual cramps, headaches, colds, and the flu. NSAIDs are available by prescription and OTC. Examples of NSAIDs include ibuprofen, naproxen, diclofenac, and celecoxib (see Table 1 for a list of NSAIDs).
The risk of heart attack and stroke with NSAIDs, either of which can lead to death, was first described in 2005 in the Boxed Warning and Warnings and Precautions sections of the prescription drug labels. Since then, we have reviewed a variety of new safety information on prescription and OTC NSAIDs, including observational studies,1 a large combined analysis of clinical trials,2 and other scientific publications.1 These studies were also discussed at a joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee held on February 10-11, 2014.
Based on the FDA's review and the advisory committees’ recommendations, the prescription NSAID labels will be revised to reflect the following information:
- The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID.
- The risk appears greater at higher doses.
It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.
NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.
In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline.
Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.
There is an increased risk of heart failure with NSAID use.
In addition, the format and language contained throughout the labels of prescription NSAIDs will be updated to reflect the newest information available about the NSAID class.
Patients and health care professionals should remain alert for heart-related side effects the
entire time that NSAIDs are being taken. The FDA urges you to report side effects involving
NSAIDs to the FDA MedWatch program, using the information in the “Contact FDA”
box at the bottom of the page.
Facts about non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs)
• NSAIDs are a class of medicines available by prescription and over-the-counter
(OTC). They are some of the most commonly used pain medicines.
• NSAIDs are used to treat pain and fever from medical conditions such as arthritis,
menstrual cramps, headaches, colds, and the flu.
• Examples of NSAIDs include ibuprofen, naproxen, diclofenac, and celecoxib.
See Table 1 for a list of non-aspirin NSAIDs.
Additional Information for Patients and Consumers
• Non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance
of a heart attack or stroke, either of which can lead to death. There are a large
number of studies that support this finding, with varying estimates of how much
the risk is increased, depending on the drugs and the doses studied. These serious
side effects can occur as early as the first weeks of using an NSAID and the risk
may increase the longer you are taking an NSAID.
• The risk appears greater at higher doses; use the lowest effective amount for the
shortest possible time.
• Seek medical attention immediately if you experience symptoms such as:
• Chest pain
• Shortness of breath or trouble breathing
• Sudden weakness or numbness in one part or side of the body
• Sudden slurred speech
• Many medicines contain NSAIDs, including those used for colds, flu, and sleep,
so it is important to read the labels and avoid taking multiple medicines that
contain NSAIDs.
• Patients who take low-dose aspirin for protection against heart attack and stroke
should know that some NSAIDs, including those in over-the-counter (OTC)
products such as ibuprofen and naproxen, can interfere with that protective effect.
• Read the patient Medication Guide you receive with your NSAID prescription. It
explains the risks associated with the use of the medicine. You may access
Medication Guides by clicking on this link.
• Read the Drug Facts label before taking an OTC NSAID. Talk to your health care
professional or pharmacist if you have questions or concerns about NSAIDs or
which medicines contain them.
• Report side effects from NSAIDs to the FDA MedWatch program, using the
information in the "Contact FDA" box at the bottom of this page.
Additional Information for Health Care Professionals
• Non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased
risk of serious cardiovascular thrombotic events, including myocardial infarction
and stroke, either of which can be fatal. There are a large number of studies that
support this finding, with varying estimates of how much the risk is increased.
Estimates of increased risk range from 10 percent to 50 percent or more,
depending on the drugs and the doses studied. This risk may occur as early as the
first weeks of treatment and may increase with duration of use.
• Remain alert for the development of cardiovascular adverse events throughout the
patient’s entire treatment course, even in the absence of previous cardiovascular
symptoms.
• Inform patients to seek medical attention immediately if they experience
symptoms of heart attack or stroke such as chest pain, shortness of breath or
trouble breathing, sudden weakness or numbness in one part or side of the body,
or sudden slurred speech.
• Encourage patients to read the Medication Guide for prescription NSAIDs and the
Drug Facts label for over-the-counter (OTC) NSAIDs.
• Based on available data, it is unclear whether the risk for cardiovascular
thrombotic events is similar for all non-aspirin NSAIDs.
• The increase in cardiovascular thrombotic risk has been observed most
consistently at higher doses.
• The relative increase in serious cardiovascular thrombotic events over baseline
conferred by NSAID use appears to be similar in those with and without known
cardiovascular disease or risk factors for cardiovascular disease. However,
patients with known cardiovascular disease or risk factors had a higher absolute
incidence of serious cardiovascular thrombotic events due to their increased
baseline rate.
• To minimize the risk for an adverse cardiovascular event in patients treated with
an NSAID, prescribe the lowest effective dose for the shortest duration possible.
• Some NSAIDs, including those in OTC products such as ibuprofen and naproxen,
can interfere with the antiplatelet action of low dose aspirin used for
cardioprotection by blocking aspirin’s irreversible COX-1 inhibition.
• Report adverse events involving NSAIDs to the FDA MedWatch program, using
the information in the "Contact FDA" box at the bottom of this page.
Data Summary
FDA reviewed a meta-analysis of randomized clinical trials of cardiovascular and upper
gastrointestinal events with non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs),
conducted by the Coxib and traditional NSAID Trialists’ (CNT) Collaboration of the
Clinical Trial Service and Epidemiological Studies Units at Oxford University.2
We also reviewed observational studies and other scientific publications in the medical literature.1
The findings of these studies were discussed at a joint meeting of the Arthritis Advisory
Committee and Drug Safety and Risk Management Advisory Committee held on
February 10-11, 2014 (for complete safety reviews, background information, and minutes
of this meeting, click here).
Based on the FDA's comprehensive review and the recommendations from the advisory committees, we are requiring label changes to reflect the following conclusions:
• A large number of studies support the finding that NSAIDs cause an increased
risk of serious cardiovascular thrombotic events, with varying estimates of how
much the risk is increased. Estimates of increased relative risk range from 10
percent to 50 percent or more, depending on the drugs and the doses studied.
• Several observational studies found a significant cardiovascular risk within days
to weeks of NSAID initiation. Some data also showed a higher risk with longer
NSAID treatment.
• There are observational data indicating that the thrombotic cardiovascular risk
from NSAID use is dose-related. There is also some evidence of this doseresponse
effect from clinical trials of celecoxib.
• Some observational studies and the CNT meta-analysis suggested that naproxen
may have a lower risk for cardiovascular thrombotic events compared to the other
NSAIDs; however, the observational studies and the indirect comparisons used in
the meta-analysis to assess the risk of the nonselective NSAIDs have limitations
that affect their interpretability. The variability in patients’ risk factors,
comorbidities, concomitant medications and drug interactions, doses being used,
duration of treatment, etc., also need to be taken into consideration to make valid
comparisons. Importantly, these studies were not designed to demonstrate
superior safety of one NSAID compared to another.
• There is evidence of an increased cardiovascular risk from NSAID use by
apparently healthy patients. Data from the CNT meta-analysis, individual
randomized controlled trials, and observational studies showed that the relative
increase in cardiovascular thrombotic events over baseline conferred by NSAID
use appears to be similar in those with and without known cardiovascular disease
or risk factors for cardiovascular disease. However, patients with known
cardiovascular disease or risk factors had a higher absolute incidence of excess
cardiovascular thrombotic events due to their increased baseline rate.
• The CNT meta-analysis demonstrated an approximately two-fold increase in
hospitalizations for heart failure with use of both COX-2 selective and
nonselective NSAIDs. In a Danish National Registry study of patients with heart
failure, NSAID use increased the risk of myocardial infarction, hospitalization for
heart failure, and death.
The Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen
or Naproxen (PRECISION) trial, is a large, ongoing randomized safety trial comparing
cardiovascular event rates among patients with high cardiovascular risk who are
randomized to celecoxib, naproxen, or ibuprofen. This trial was also discussed at the
February 2014 Advisory Committee meeting and is expected to provide additional safety
information.
Table 1. List of non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs)
Generic name Brand name(s)
- celecoxib Celebrex
- diclofenac Cambia, Cataflam, Dyloject, Flector,
- Pennsaid, Solaraze, Voltaren, Voltaren-XR,
- Zipsor, Zorvolex, Arthrotec (combination
- with misoprostol)
- diflunisal No brand name currently marketed
- etodolac No brand name currently marketed
- fenoprofen Nalfon
- flurbiprofen Ansaid
- ibuprofen* Advil, Caldolor, Children’s Advil,
- Children’s Elixsure IB, Children’s Motrin,
- Ibu-Tab, Ibuprohm, Motrin IB, Motrin
- Migraine Pain, Profen, Tab-Profen, Duexis
- (combination with famotidine), Reprexain
- (combination with hydrocodone),
- Vicoprofen (combination with
- hydrocodone)
- indomethacin Indocin, Tivorbex
- ketoprofen No brand name currently marketed
- ketorolac Sprix
- mefenamic acid Ponstel
- meloxicam Mobic
- nabumetone No brand name currently marketed
- naproxen* Aleve, Anaprox, Anaprox DS, ECNaprosyn,
- Naprelan, Naprosyn, Treximet
- (combination with sumatriptan), Vimovo
- (combination with esomeprazole)
- oxaprozin Daypro
- piroxicam Feldene
- sulindac Clinoril
- tolmetin No brand name currently marketed *There are many over-the-counter (OTC) products that contain this medicine.
References
1. Food and Drug Administration [Internet]. Silver Spring, MD. FDA Briefing
Information for the February 10-11, 2014 Joint Meeting of the Arthritis Advisory
Committee and Drug Safety and Risk Management Advisory Committee. Available
from:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM383180.pdf. Accessed December 23, 2014.
….
Jon L. Gelman of Wayne NJ is the author of NJ Workers’ Compensation Law (West-Thompson-Reuters) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thompson-Reuters). For over 4 decades the Law Offices of Jon L Gelman 1.973.696.7900 jon@gelmans.com have been representing injured workers and their families who have suffered occupational accidents and illnesses.
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Monday, April 27, 2009
Homeland Security Takes Lead in Flu Pandemic Pointing to Compensation Programs
The U.S. Department of Homeland Security (USDHS) has emerged as the lead agency in directing a response to the potential swine flu pandemic. The agency is following a well defined plan published in 2005 to respond to the threat in an effort to secure the Nation's critical infrastructure and key resources (CI/KR). The viability of business in the US remains a critical aspect of the plan and the workers' compensation system is critical tool in the implementation of the response.
The threat is defined as serious. "The (1918 Spanish Influenza} epidemic killed, at a very, very conservative estimate, 550,000 Americans in 10 months; that's more Americans than died in combat in all the wars of this century." Alfred W. Crosby, Influenza, 1918, The American Experience.
While pandemics are unpredictable, the USDHS has estimated that the disease attack rate will be 30 percent in the overall population during the pandemic. The agency estimates that an average of 20 percent of working adults will become ill during a community outbreak. Multiple waves of the disease will occur with each lasting 2 or 3 months.
The approach taken by the Federal government will be to assess the threat and direct coordination with the State agencies. A fundamental part of the plan is to provide psychosocial support and meet the informational needs of the workforce and develop contingency plans for absenteeism, especially among health department groups and develop workforce resiliency.
As the situation unfolds, workers' compensation programs will be tasked to new limits. Much is unknown, "...We are telling everyone to prepare for a pandemic. It's tricky....This is scary and we don't know....That's the message." Dick Thompson, World Health Organization. By directing ill workers to appropriate compensation programs, the USDHS has taken the initial steps necessary to respond to changing conditions and rumors.
Tuesday, October 27, 2009
HIPPA Privacy Modifications Under Presidential Emergency H1N1 Flu Order
Under the emergency declaration for H1N1 flu signed by President Obama on October 24, 2009, the HIPPA Privacy rule is not waived according to Federal HHS interpretation; however, "the Secretary of HHS may waive certain provisions of the Rule under the Project Bioshield Act of 2004 (PL 108-276) and section 1135(b)(7) of the Social Security Act."
Those modifications are:
"If the President declares an emergency or disaster and the Secretary declares a public health emergency, the Secretary may waive sanctions and penalties against a covered hospital that does not comply with certain provisions of the HIPAA Privacy Rule:
1. In the emergency area and for the emergency period identified in the public health emergency declaration.
Those modifications are:
"If the President declares an emergency or disaster and the Secretary declares a public health emergency, the Secretary may waive sanctions and penalties against a covered hospital that does not comply with certain provisions of the HIPAA Privacy Rule:
- the requirements to obtain a patient's agreement to speak with family members or friends involved in the patient’s care (45 CFR 164.510(b))
- the requirement to honor a request to opt out of the facility directory (45 CFR 164.510(a))
- the requirement to distribute a notice of privacy practices (45 CFR 164.520)
- the patient's right to request privacy restrictions (45 CFR 164.522(a))
- the patient's right to request confidential communications (45 CFR 164.522(b))
1. In the emergency area and for the emergency period identified in the public health emergency declaration.
2. To hospitals that have instituted a disaster protocol. The waiver would apply to all patients at such hospitals.
3. For up to 72 hours from the time the hospital implements its disaster protocol.
"When the Presidential or Secretarial declaration terminates, a hospital must then comply with all the requirements of the Privacy Rule for any patient still under its care, even if 72 hours has not elapsed since implementation of its disaster protocol.
"Regardless of the activation of an emergency waiver, the HIPAA Privacy Rule permits disclosures for treatment purposes and certain disclosures to disaster relief organizations. For instance, the Privacy Rule allows covered entities to share patient information with the American Red Cross so it can notify family members of the patient’s location. See 45 CFR 164.510(b)(4)."
Wednesday, September 3, 2014
CVS Stores Stop Selling All Tobacco Products
Today's post is shared from nytimes.com At a CVS store near Times Square, the shelves are notable for what they no longer display: cigarettes. Now the only smoking products to be found are those that could help customers quit. As of midnight on Tuesday, all 7,700 CVS locations nationwide will no longer sell tobacco products, fulfilling a pledge the company made in February, as it seeks to reposition itself as a health care destination. The rebranding even comes with a new name: CVS Health. The decision to stop selling cigarettes is a strategic move as pharmacies across the country jockey for a piece of the growing health care industry. Rebranding itself as a company focused on health could prove lucrative for the drugstore as it seeks to appeal to medical partners that can help it bridge the gap between customers and their doctors. “CVS is really trying very hard to position themselves as the winner in that marketplace,” said Skip Snow, a health care analyst at Forrester Research. “If they can be perceived as a place to go to receive health care, and buy health care products, as opposed to the place to go to buy a bottle of whiskey or get your film developed, then they can capture more of the retail medicine dollars.” CVS already operates 900 walk-in medical clinics, or “minute clinics,” where customers can get relatively simple services like blood pressure tests and flu vaccines. By dedicating space for these services, CVS and other major retailers like Walmart are diving into... |
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Sunday, October 20, 2013
Work resumes at federal public health agencies
Congressional agreement on a funding bill that reopened government yesterday got the gears turning again with several key public health tasks, such as flu surveillance, science communication, and lab testing.
Within hours of President Obama's signing of the legislation, some of the US Centers for Disease Control and Prevention's Twitter accounts crackled to life again, including one used by its director, Tom Frieden, MD, MPH, who wrote, "So relieved to have the best and brightest back to work protecting and promoting health. Hope for no relapse…" Government employees who had been furloughed were asked to return yesterday. At the CDC all but 4,000 of about 13,000 employees were furloughed. A few were called back to manage a Salmonella Heidelberg outbreak linked to three Foster Farms processing facilities in California. Barbara Reynolds, PhD, who directs the CDC's division of public affairs, was the point person who fielded media queries while many of her colleagues were furloughed. She told CIDRAP News yesterday that the CDC is operating as it did before the shutdown, and that its scientists and health officials can resume needed travel and attend meetings. Throughout the day yesterday, the CDC posted several notices on its Web site signaling that its activities were returning to normal. It posted a notice that its weekly FluView surveillance reports would return today, but in an abbreviated form, after a 2-week absence. The lack of reports created an... |
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