President Biden signed legislation that will provide medical benefits from the Veterans Administration to service members exposed to toxic burn pits while deployed overseas in recent conflicts. The President signed the Sargent First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics (PACT) Act. It embodies some of the goals we strived to achieve in the decades-long burn pit litigation project.
Showing posts sorted by date for query registry. Sort by relevance Show all posts
Showing posts sorted by date for query registry. Sort by relevance Show all posts
Wednesday, August 10, 2022
Friday, October 22, 2021
Biden Administration Targets Occupational Exposure to PFAS
The Biden-Harris Administration announced accelerated efforts to protect American workers from per- and polyfluoroalkyl substances (PFAS), which can cause severe health problems and persist in the environment once released, posing a severe threat across rural, suburban, and urban areas.
Monday, March 29, 2021
Rubio, Gillibrand Introduce Landmark Burn Pits Legislation to Help Veterans
U.S. Senators Marco Rubio (R-FL) and Kirsten Gillibrand (D-NY) introduced the bipartisan and bicameral Presumptive Benefits for War Fighters Exposed to Burn Pits and Other Toxins Act. U.S. Representatives Raul Ruiz, M.D (D-CA) and Brian Fitzpatrick (R-PA) will introduce the legislation in the U.S. House of Representatives. This bill would provide presumptive U.S. Department of Veterans Affairs benefits to servicemembers who have deployed and have illnesses due to exposure to burn pits and other toxins. Approximately 3.5 million veterans have been exposed to burn pits that spewed toxic fumes and carcinogens into the air.
Monday, December 7, 2020
NJ Plans to Enroll COVID-19 Recipients in the New Jersey Immunization Information System
If you receive a COVID-19 vaccine in the state of New Jersey you will be now automatically enrolled in the New Jersey Immunization Information System (NJIIS). This information will reduce paperwork and increase efficiency and provide record-keeping data for those who are authorized to receive this information. The information will be electronically stored and available over the Internet 24 hours a day, seven days a week.
Sunday, December 29, 2019
Law Enacted to Phase-Out Use of Military Burn Pits
Recent legislation passed Congress and signed by the President last week mandates the phase-out burn pits used by the United States military. The law provides for medical monitoring and health assessments of military members who have been exposed to toxic chemicals or airborne contaminants from burn pits. This legislation follows the dismissal, almost a year ago, of litigation against third-party contractors by service members, and their dependents, who became ill after alleged exposure to the toxic fumes where burn pits were utilized in the Iraq and Afghanistan wars.
Saturday, May 11, 2019
Firefighter Cancer Registry
To better examine firefighters’ exposure to carcinogens and its effects, legislation sponsored by Yvonne Lopez, Annette Quijano and John Armato to establish a voluntary firefighter cancer registry was signed into law Friday by Governor Phil Murphy.
Tuesday, April 16, 2019
CDC has requested comments for the feasibility of a mesothelioma registry
The National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), has announced the opening of a docket to obtain information on the feasibility of a registry designed to track mesothelioma cases in the United States, as well as recommendations on enrollment, data collection, confidentiality, and registry maintenance. The purpose of such a registry would be to collect information that could be used to develop and improve standards of care and to identify gaps in mesothelioma prevention and treatment.
Friday, April 5, 2019
A Surge in Groundskeeper/Landscaper Cancer Claims Foreseeable
The second jury verdict that occurred in California against Monsanto/Bayer for cancer arising out of exposure to Roundup that contained glyphosate may foreshadow a surge in workers’ compensation cancer claims for groundskeepers and landscapers.
Sunday, March 3, 2019
Burn Pit Bill advances to US House Schedule Next week
H.R. 1381: To direct the Secretary of Veterans Affairs to take actions necessary to ensure that certain individuals may update the burn pit registry with a registered individual’s cause of death, and for other purposes.
Saturday, March 2, 2019
Dr. Ruiz Announces Progress on Burn Pits Bill
For the first time, the bipartisan Burn Pits Registry Enhancement Act has a bipartisan companion in the Senate and is closer than ever to becoming law.
Monday, May 28, 2018
US Burn Pit Legislation: Bipartisan Bill to Evaluate US Troops Exposure to Toxic Burn Pits
Reps. Tulsi Gabbard (HI-02) and Brian Mast (FL-18), along with Iraq and Afghanistan Veterans of America (IAVA), hosted a press conference today urging their colleagues to support and pass the Burn Pits Accountability Act (H.R. 5671). The bipartisan legislation would evaluate the exposure of U.S. servicemembers to open burn pits and toxic airborne chemicals.
Thursday, March 29, 2018
NJ Expands Access to Medical Marijuana to Include Common Work-Related Conditions
Governor Phil Murphy announced major reforms to New Jersey’s Medicinal Marijuana Program. The permitted medical conditions now include many common work-related medical conditions.
Friday, April 8, 2016
National Asbestos Awareness Week - US Surgeon General
U.S. Surgeon General Dr. Vivek H. Murthy on National Asbestos Awareness Week
 |
| Dr. Vivek Murthy US Surgeon General |
National Asbestos Awareness Week is April 1-7 – a good time to remind Americans about the health dangers of asbestos exposure. Asbestos, a natural mineral fiber that is found in rock and soil, was widely used as insulation and fireproofing material in homes, commercial buildings, ships and other products, such as paints and car brakes. In recent years, asbestos use has decreased dramatically after it was linked to illnesses, including lung cancer, mesothelioma, and asbestosis.
Thursday, July 23, 2015
Misclassification: US Dept of Labor Issues Interpretation of Employment Status
The Application of the Fair Labor Standards Act’s “Suffer or Permit” Standard in the Identification of Employees Who Are Misclassified as Independent Contractors.
Sounding very much like a workers' compensation standardized employment status test, the US Department of Labor has added its interpretation this developing area of the law. This memo will has obvious added consequences to state interpretation to this issue.
Sounding very much like a workers' compensation standardized employment status test, the US Department of Labor has added its interpretation this developing area of the law. This memo will has obvious added consequences to state interpretation to this issue.
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.
Tuesday, June 23, 2015
Workers' Exposure to Low Dose Radiation Linked to Leukemia and Lymphoma
Workers exposed to low doses of radiation have been reported to experience an increased risk to Leukemia and Lymphoma.
A study published in The Lancet reports strong evidence of positive associations between protracted low-dose radiation exposure and leukemia.
Evidence before this study:
Ionising radiation causes leukaemia. The primary quantitative basis for radiation protection standards comes from studies of populations exposed to acute, high doses of ionising radiation. Although previous studies of nuclear workers addressed leukaemia radiogenicity, questions remain about the size of the risk from protracted radiation exposure in occupational settings.
Added value of this study:
We report a positive dose–response relationship between cumulative, external, protracted, low-dose exposure to ionising radiation, and subsequent death caused by leukeamia (excluding chronic lymphocytic leukaemia). The risk coefficient per unit dose was consistent with those derived from analyses of other populations exposed to higher radiation doses and dose rates.
Implications of all the available evidence:
The present study provides strong evidence of a positive association between radiation exposure and leukaemia even for low-dose exposure. This finding shows the importance of adherence to the basic principles of radiation protection—to optimise protection to reduce exposures as much as reasonably achievable and—in the case of patient exposure—to justify that the exposure does more good than harm.
A study published in The Lancet reports strong evidence of positive associations between protracted low-dose radiation exposure and leukemia.
Evidence before this study:
Ionising radiation causes leukaemia. The primary quantitative basis for radiation protection standards comes from studies of populations exposed to acute, high doses of ionising radiation. Although previous studies of nuclear workers addressed leukaemia radiogenicity, questions remain about the size of the risk from protracted radiation exposure in occupational settings.
Added value of this study:
We report a positive dose–response relationship between cumulative, external, protracted, low-dose exposure to ionising radiation, and subsequent death caused by leukeamia (excluding chronic lymphocytic leukaemia). The risk coefficient per unit dose was consistent with those derived from analyses of other populations exposed to higher radiation doses and dose rates.
Implications of all the available evidence:
The present study provides strong evidence of a positive association between radiation exposure and leukaemia even for low-dose exposure. This finding shows the importance of adherence to the basic principles of radiation protection—to optimise protection to reduce exposures as much as reasonably achievable and—in the case of patient exposure—to justify that the exposure does more good than harm.
Tuesday, February 3, 2015
The proposed FACT Act delays compensation for asbestos victims, puts privacy at risk
Washington, D.C. — The following is a statement from American Association for Justice CEO Linda Lipsen on the introduction of the Furthering Asbestos Claims Transparency (FACT) Act in the U.S. House of Representatives:
“With nearly 10,000 Americans suffocating every year from horrific asbestos diseases like mesothelioma, Congress should be focused on ensuring justice for the victims and protecting the public health and safety. Instead, asbestos corporations and the U.S Chamber of Commerce have orchestrated a calculated campaign to delay and deny justice for dying asbestos victims.
“The reintroduction of the FACT Act is a reminder of the lengths asbestos corporations will go to evade being held accountable. It is offensive that the same corporations that profited from hiding the dangers of asbestos would now turn to Congress to force the public release of asbestos victims' personal information, delaying compensation and putting their privacy at risk.”
Asbestos Victims & Asbestos Trusts on H.R. 526:
H.R. 526 is a massive intrusion on the privacy of asbestos victims and their families
In a May 20, 2013 letter to the U.S. House of Representatives, asbestos victims stated:
“The FACT Act forces the asbestos trust funds to reveal on a public database personally-identifiable information about asbestos victims and their families. This would include private work history, asbestos exposure information, the last four digits of their social security numbers, and even the personal information of children who were exposed at an early age. This is offensive. The information on this public registry could be used to deny employment, credit, and health, life, and disability insurance. We are also concerned that victims would be more vulnerable to identity thieves, con men, and other types of predators.”
H.R. 526 will lead to higher costs for asbestos trusts and compensation delays for asbestos victims
In a November 8, 2013 letter to the U.S. House of Representatives, asbestos trusts stated:
“The bill does not, as its proponents claim, protect either the trusts or their beneficiaries. Rather, the bill merely changes the rules in the tort system so as to impose increased costs on the trusts' claimants. The litigation advantage that this bill provides to solvent asbestos defendants is its only practical purpose. … the trusts believe that the bill will unduly and unnecessarily increase the trusts' administrative burdens and will inevitably lead to higher non-reimbursable costs and delays in the processing of claims and payment to holders of asbestos claims. Such a bill does not protect the trusts or their beneficiaries; it burdens them.”
“With nearly 10,000 Americans suffocating every year from horrific asbestos diseases like mesothelioma, Congress should be focused on ensuring justice for the victims and protecting the public health and safety. Instead, asbestos corporations and the U.S Chamber of Commerce have orchestrated a calculated campaign to delay and deny justice for dying asbestos victims.
“The reintroduction of the FACT Act is a reminder of the lengths asbestos corporations will go to evade being held accountable. It is offensive that the same corporations that profited from hiding the dangers of asbestos would now turn to Congress to force the public release of asbestos victims' personal information, delaying compensation and putting their privacy at risk.”
Asbestos Victims & Asbestos Trusts on H.R. 526:
H.R. 526 is a massive intrusion on the privacy of asbestos victims and their families
In a May 20, 2013 letter to the U.S. House of Representatives, asbestos victims stated:
“The FACT Act forces the asbestos trust funds to reveal on a public database personally-identifiable information about asbestos victims and their families. This would include private work history, asbestos exposure information, the last four digits of their social security numbers, and even the personal information of children who were exposed at an early age. This is offensive. The information on this public registry could be used to deny employment, credit, and health, life, and disability insurance. We are also concerned that victims would be more vulnerable to identity thieves, con men, and other types of predators.”
H.R. 526 will lead to higher costs for asbestos trusts and compensation delays for asbestos victims
In a November 8, 2013 letter to the U.S. House of Representatives, asbestos trusts stated:
“The bill does not, as its proponents claim, protect either the trusts or their beneficiaries. Rather, the bill merely changes the rules in the tort system so as to impose increased costs on the trusts' claimants. The litigation advantage that this bill provides to solvent asbestos defendants is its only practical purpose. … the trusts believe that the bill will unduly and unnecessarily increase the trusts' administrative burdens and will inevitably lead to higher non-reimbursable costs and delays in the processing of claims and payment to holders of asbestos claims. Such a bill does not protect the trusts or their beneficiaries; it burdens them.”
….
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.
Saturday, November 1, 2014
Pets Allowed
The author discusses "Service-Dogs" and "Emotional-Support Animals" [ESA]. Today's interesting post is shared from newyorker.com What a wonderful time it is for the scammer, the conniver, and the cheat: the underage drinkers who flash fake I.D.s, the able-bodied adults who drive cars with handicapped license plates, the parents who use a phony address so that their child can attend a more desirable public school, the customers with eleven items who stand in the express lane. The latest group to bend the law is pet owners. Take a look around. See the St. Bernard slobbering over the shallots at Whole Foods? Isn’t that a Rottweiler sitting third row, mezzanine, at Carnegie Hall? As you will have observed, an increasing number of your neighbors have been keeping company with their pets in human-only establishments, cohabiting with them in animal-unfriendly apartment buildings and dormitories, and taking them (free!) onto airplanes—simply by claiming that the creatures are their licensed companion animals and are necessary to their mental well-being. No government agency keeps track of such figures, but in 2011 the National Service Animal Registry, a commercial enterprise that sells certificates, vests, and badges for helper animals, signed up twenty-four hundred emotional-support animals. Last year, it registered eleven thousand. What about the mental well-being of everyone else? One person’s emotional support can be... |
Sunday, June 29, 2014
FDA approves device that helps people with certain spinal cord injuries to walk
The U.S. Food and Drug Administration today allowed marketing of the first motorized device intended to act as an exoskeleton for people with lower body paralysis (paraplegia) due to a spinal cord injury. ReWalk is a motorized device worn over the legs and part of the upper body that helps an individual sit, stand, and walk with assistance from a trained companion, such as a spouse or home health aide.
According to the U.S. Centers for Disease Control and Prevention there are about 200,000 people in the United States living with a spinal cord injury, many of whom have complete or partial paraplegia.
“Innovative devices such as ReWalk go a long way towards helping individuals with spinal cord injuries gain some mobility,” said Christy Foreman, director of the Office of Device Evaluation, at the FDA’s Center for Devices and Radiological Health. “Along with physical therapy, training and assistance from a caregiver, these individuals may be able to use these devices to walk again in their homes and in their communities.”
ReWalk consists of a fitted, metal brace that supports the legs and part of the upper body; motors that supply movement at the hips, knees, and ankles; a tilt sensor; and a backpack that contains the computer and power supply. Crutches provide the user with additional stability when walking, standing, and rising up from a chair. Using a wireless remote control worn on the wrist, the user commands ReWalk to stand up, sit down or walk.
ReWalk is for people with paraplegia due to spinal cord injuries at levels T7 (seventh thoracic vertebra) to L5 (fifth lumbar vertebra) when accompanied by a specially trained caregiver. It is also for people with spinal cord injuries at levels T4 (fourth thoracic vertebra) to T6 (sixth thoracic vertebra) where the device is limited to use in rehabilitation institutions. The device is not intended for sports or climbing stairs.
Prior to being trained to use ReWalk, patients should be able to stand using an assistive standing device (e.g., standing frame), and their hands and shoulders should be able to support crutches or a walker. Patients should not use the device if they have a history of severe neurological injuries other than spinal cord injury, or have severe spasticity, significant contractures, unstable spine, unhealed limb fractures or pelvic fractures. Patients should also not use the device if they have severe concurrent medical diseases such as infection, circulatory conditions, heart or lung conditions, or pressure sores.
Patients and their caregivers must undergo training developed by the manufacturer to learn and demonstrate proper use of the device.
To assess safety and effectiveness of ReWalk, the FDA reviewed testing done to assess ReWalk’s durability, its hardware, software and battery systems, and other safety systems that help minimize risk of injury should the device lose balance or power.
The FDA also reviewed clinical data based on 30 study participants. The clinical tests assessed the participants’ ability to walk various distances, the amount of time needed to walk various distances, performance on various walking surfaces and slight slopes, and performance walking in areas where jostling might occur. Studies also assessed the risk of certain physical effects on the user. Additionally, observational data from 16 patients were also provided to support use of the device on various walking surfaces in the home and community with various levels of assistance from a trained companion. Risks associated with ReWalk include pressure sores, bruising or abrasions, falls and associated injuries, and diastolic hypertension during use.
The FDA reviewed the ReWalk through its de novo classification process, a regulatory pathway for novel, first-of-its-kind medical devices that are generally low-to moderate-risk. The FDA is requiring Argo Medical Technologies, Inc., the manufacturer of ReWalk, to complete a post-market clinical study that will consist of a registry to collect data on adverse events related to the use of the ReWalk device and prospectively and systematically assess the adequacy of its training program.
According to the U.S. Centers for Disease Control and Prevention there are about 200,000 people in the United States living with a spinal cord injury, many of whom have complete or partial paraplegia.
“Innovative devices such as ReWalk go a long way towards helping individuals with spinal cord injuries gain some mobility,” said Christy Foreman, director of the Office of Device Evaluation, at the FDA’s Center for Devices and Radiological Health. “Along with physical therapy, training and assistance from a caregiver, these individuals may be able to use these devices to walk again in their homes and in their communities.”
ReWalk consists of a fitted, metal brace that supports the legs and part of the upper body; motors that supply movement at the hips, knees, and ankles; a tilt sensor; and a backpack that contains the computer and power supply. Crutches provide the user with additional stability when walking, standing, and rising up from a chair. Using a wireless remote control worn on the wrist, the user commands ReWalk to stand up, sit down or walk.
ReWalk is for people with paraplegia due to spinal cord injuries at levels T7 (seventh thoracic vertebra) to L5 (fifth lumbar vertebra) when accompanied by a specially trained caregiver. It is also for people with spinal cord injuries at levels T4 (fourth thoracic vertebra) to T6 (sixth thoracic vertebra) where the device is limited to use in rehabilitation institutions. The device is not intended for sports or climbing stairs.
Prior to being trained to use ReWalk, patients should be able to stand using an assistive standing device (e.g., standing frame), and their hands and shoulders should be able to support crutches or a walker. Patients should not use the device if they have a history of severe neurological injuries other than spinal cord injury, or have severe spasticity, significant contractures, unstable spine, unhealed limb fractures or pelvic fractures. Patients should also not use the device if they have severe concurrent medical diseases such as infection, circulatory conditions, heart or lung conditions, or pressure sores.
Patients and their caregivers must undergo training developed by the manufacturer to learn and demonstrate proper use of the device.
To assess safety and effectiveness of ReWalk, the FDA reviewed testing done to assess ReWalk’s durability, its hardware, software and battery systems, and other safety systems that help minimize risk of injury should the device lose balance or power.
The FDA also reviewed clinical data based on 30 study participants. The clinical tests assessed the participants’ ability to walk various distances, the amount of time needed to walk various distances, performance on various walking surfaces and slight slopes, and performance walking in areas where jostling might occur. Studies also assessed the risk of certain physical effects on the user. Additionally, observational data from 16 patients were also provided to support use of the device on various walking surfaces in the home and community with various levels of assistance from a trained companion. Risks associated with ReWalk include pressure sores, bruising or abrasions, falls and associated injuries, and diastolic hypertension during use.
The FDA reviewed the ReWalk through its de novo classification process, a regulatory pathway for novel, first-of-its-kind medical devices that are generally low-to moderate-risk. The FDA is requiring Argo Medical Technologies, Inc., the manufacturer of ReWalk, to complete a post-market clinical study that will consist of a registry to collect data on adverse events related to the use of the ReWalk device and prospectively and systematically assess the adequacy of its training program.
Saturday, January 4, 2014
New York State Is Set to Loosen Marijuana Laws
Changes in the delivery of medications in workers' compensation has become a hot issue recently. While employers and insurance companies attempt to restrict maintenance medications for pain especially, the use of medical marijuana is becoming widely adopted, and in Colorado it has been adopted for recreational use. See also the The Complex World of Workers' Compensation and Pharmaceutical Benefits. Today's post is shared from the nytimes.com.
ALBANY — Joining a growing group of states that have loosened restrictions on marijuana, Gov. Andrew M. Cuomo of New York plans this week to announce an executive action that would allow limited use of the drug by those with serious illnesses, state officials say.  Mr. Cuomo’s plan will be far more restrictive than the laws in Colorado or California, where medical marijuana is available to people with conditions as mild as backaches. It will allow just 20 hospitals across the state to prescribe marijuana to patients with cancer, glaucoma or other diseases that meet standards to be set by the New York State Department of Health. While Mr. Cuomo’s measure falls well short of full legalization, it nonetheless moves New York,... |
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