A significant concern of employees, employers, and insurance companies is whether or not the new COVID-19 vaccines are safe to take. Vaccine efficacy is going to have a significant impact on the decision-making process.
Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts
Monday, December 7, 2020
Friday, September 4, 2020
Workplace Testing - Pandemic Preparedness Strategy for Success
Maintaining a safe workplace is a crucial strategy in the era of COVID-19. Today's guest author, Michael Gelman, MD PhD, discusses how testing can play a critical role going forward.
A lot of people are getting very excited about Michael Mina’s proposed strategy of cheap, rapid, frequent testing. From his Op-Ed in the Times, to his appearance on TWiV, to this article in the Atlantic, there’s a lot of hope around the potential for inexpensive antigen tests, like the Abbott BinaxNow - which quickly got bought up by the Department of Health and Human Services through December’s anticipated production. It’s possible that another company funded by a U.S. Government initiative might come out with something as good, or better, in the near future. (And no, I don’t have any inside information on any of this. Not that I haven’t asked around.) All this comes amid the CDC’s controversial revision of its testing guidelines, as well as a recent FDA statement that points out the unknowns around repurposing a test, which was originally developed for diagnosis, to screen large numbers of asymptomatic persons. Meanwhile, another Times article points out what many of us have known for months: that a positive PCR test late in the course of illness may be more of a hindrance than a help.
Friday, June 14, 2019
Cosmetic Products Containing Asbestos Recalled
Hazardous cosmetic products containing deadly asbestos fiber continue to appear in the workplace. The US Food and Drug Administration (FDA) has recently issued an alert concerning a voluntary recall concerning one of those cosmetic products.
· Beauty Plus Global Contour Effects Palette 2, Batch No. S1603002/PD-C1179
· Claire’s JoJo Siwa Makeup Set, SKU #888711136337, Batch/Lot No. S180109
Consumers who have these batches/Lots of Beauty Plus or Claire's products should stop using them.
The FDA is advising consumers not to use any of the following products.
Health care professionals and consumers are encouraged to report any adverse events to FDA’s MedWatch Adverse Event Reporting program by:
· Completing and submitting the report online at MedWatch Online Voluntary Reporting Form
· Downloading and completing the form, then submitting it via fax at 1-800-FDA-0178
For more information on FDA's investigation of potential asbestos contamination in cosmetics, see the FDA’s Talc
Tuesday, April 9, 2019
US FDA Moves to Further Regulate Marijuana Products
US Food and Drug Administration [FDA] announced a public hearing to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.
Friday, February 9, 2018
Congressman Pallone Asks FDA to Investigate Cosmetic Products Containing Asbestos
Standing outside a Claire’s Store in Sea Girt, Congressman Frank Pallone, Jr. (NJ-06) called on the Food and Drug Administration (FDA) to investigate Claire’s Stores, Inc., and Justice Retail following reports that tremolite asbestos, a known human carcinogen, was found in cosmetic products marketed to girls and young women.
Thursday, June 15, 2017
Safeguarding Injured Workers From Cybersecurity Breaches
Under new Federal proposals, injured workers will be protected from cybersecurity breaches. The impact will be greater responsibilities and costs for law firms and, employers and their insurance companies.
Monday, May 16, 2016
Some medicines are just not for sick people: Fluoroquinolone
Obtaining fast and effective medical treatment after suffering and occupational accident or injury is important. Receiving the improper medication can made outcomes a lot worse The FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections and warns about disabling side effects that can occur together.
Tuesday, August 12, 2014
Colgate Total Ingredient Linked to Hormones, Cancer Spotlights FDA Process
 Photographer: Daniel Acker/Bloomberg The chemical triclosan has been linked to cancer-cell growth and disrupted development in animals. Regulators are reviewing whether it’s safe to put in soap, cutting boards and toys. Consumer companies are phasing it out. Minnesota voted in May to ban it in many products. At the same time, millions of Americans are putting it in their mouths every day, by way of a top-selling toothpaste that uses the antibacterial chemical to head off gum disease -- Colgate-Palmolive Co.’s Total. Total is safe, Colgate says, citing the rigorous Food and Drug Administration process that led to the toothpaste’s 1997 approval as an over-the-counter drug. A closer look at that application process, however, reveals that some of the scientific findings Colgate put forward to establish triclosan’s safety in toothpaste weren’t black and white -- and weren’t, until this year, available to the public. Colgate’s Total application included 35 pages summarizing toxicology studies on triclosan, which the FDA withheld from view. The agency released the pages earlier this year in response to a lawsuit over a Freedom of Information Act request. Later, following inquiries from Bloomberg News, the FDA put the pages on its website. The pages show how even with one of the U.S.’s most stringent regulatory processes -- FDA approval of a new drug -- the government relies on company-backed science to show products are safe and... |
Tuesday, July 29, 2014
Take Two: Just How Good Are Generic Meds Anyway?
| A few days ago I wrote a post about generic painkillers and the fact that doctors themselves—who should know better—often don't use them. "If physicians aren't really sold on generics in their own personal lives," I asked, "does this mean they're not really sold on them in their professional lives too?" Well, perhaps I got it backwards. A friend sent me a link to a Forbes article from last year about the FDA retracting its approval of a generic version of Wellbutrin: The episode is bringing momentum to a movement that has been quietly building among many doctors and medical societies that are increasingly willing to ask a question that borders on heresy: Are generics really identical to the branded products they are meant to replicate? To a surprising degree, they say, the answer is no. |
Wednesday, July 23, 2014
FDA warns of compounded drug recall by Texas firm
| WASHINGTON — The Food and Drug Administration warned doctors Wednesday not to use compounded drugs from a Texas specialty pharmacy due to potential risks of contamination. The agency says FDA inspectors recently uncovered unsanitary conditions at Unique Pharmaceuticals’ plant in Temple, Texas. The inspections revealed production problems in several drug lots that were supposed to be sterile. “Using these products puts patients at an unacceptable risk for serious infection,” said Carol Bennett, an official in the FDA’s drug center. At the behest of regulators, Unique Pharmaceuticals has recalled all non-expired, sterile products distributed across the U.S., including a fluid used to clear mucus in patients with respiratory conditions. The company has also halted production of all other sterile drugs, which are generally solutions administered via injection or intravenous infusion. A spokesman for the company said it continues to produce other forms of drugs that do not require sterile conditions. “We are diligently working to address FDA’s concerns noted before the recall,” said David Shank, in a statement. “We have commissioned third-party independent experts to address those concerns and ensure the safety of our compounded preparations for our customers.” Shank added that the recall could contribute to shortages of medicines already in short supply. The FDA said in a statement it is not aware of any illnesses linked... |
Thursday, June 26, 2014
FDA Issues Guidances for Industry on Social Media
Today's article shared from Thomas Abrams
Ongoing changes in technology transform medical products – and the ways that both patients and health care providers learn about those products. In today’s world, in addition to traditional sources of medical product information, patients and health care providers regularly get information about FDA-regulated medical products through social media and other Internet sources, and those technologies continue to evolve. But regardless of the Internet source used to communicate about medical products, the public health is best served by clear, accurate, truthful and non-misleading information about them.
That’s why the agency has proposed two draft guidances for industry with recommendations to help manufacturers and their representatives accurately communicate online about prescription drugs and medical devices.
These documents strive to ensure that the information provided by drug and device companies is accurate and will help patients to make well-informed decisions in consultation with their health care providers.
Our first guidance provides recommendations for the presentation of risk and benefit information for prescription drugs or medical devices using Internet/social media sources with character space limitations, such as Twitter and the paid search results links on Google and Yahoo. These recommendations address the presentation of both benefit information and risk information in this setting. We understand that...
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That’s why the agency has proposed two draft guidances for industry with recommendations to help manufacturers and their representatives accurately communicate online about prescription drugs and medical devices.
These documents strive to ensure that the information provided by drug and device companies is accurate and will help patients to make well-informed decisions in consultation with their health care providers.
Our first guidance provides recommendations for the presentation of risk and benefit information for prescription drugs or medical devices using Internet/social media sources with character space limitations, such as Twitter and the paid search results links on Google and Yahoo. These recommendations address the presentation of both benefit information and risk information in this setting. We understand that...
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Related articles
F.D.A. Shift on Painkillers Was Years in the Making (workers-compensation.blogspot.com)
FDA Proposes Changes in Pain Medication Prescriptions (workers-compensation.blogspot.com)
Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigatio (workers-compensation.blogspot.com)
As Robot-Assisted Surgery Expands, Are Patients And Providers Getting Enough Information? (workers-compensation.blogspot.com)
FDA Warns Zithromax / Zmax Antibiotics Potential Risk of Fatal Heart Rhythms (workers-compensation.blogspot.com)
F.D.A. Shift on Painkillers Was Years in the Making (workers-compensation.blogspot.com)
FDA Proposes Changes in Pain Medication Prescriptions (workers-compensation.blogspot.com)
Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigatio (workers-compensation.blogspot.com)
As Robot-Assisted Surgery Expands, Are Patients And Providers Getting Enough Information? (workers-compensation.blogspot.com)
FDA Warns Zithromax / Zmax Antibiotics Potential Risk of Fatal Heart Rhythms (workers-compensation.blogspot.com)
Wednesday, March 5, 2014
Its Déjà Vu All Over Again
Today's post is shared from Judge David Langham and I would encourage to read his blog at: http://flojcc.blogspot.com/ David Langham is the Deputy Chief Judge of Compensation Claims for the Florida Office of Judges of Compensation Claims and Division of Administrative Hearings.
Zohydro is in the news yet again. This month the new medication will become available. Its manufacturer says it will market this only to a select few physicians whose experience with pain will assure their discretion and restraint in distributing this strong pain killer.
In November, I noted the approval of this new Opiod formulation, and in December, I wrote when over half the nation’s attorneys general wrote to the FDA urging that the approval receive greater scrutiny and perhaps reconsideration (Zohydro in the News Again).
Well, as Yogi Bera once said “its déjà vu all over again.” Zohydro is back in the news at the end of February. Now, an “activist” group is questioning the Food and Drug Administration (FDA)and has released a letter it sent to the FDA in late February. The group is called “Fed Up!” and their points are interesting.
They note that Zohydro is being marketed in the “midst of a severe drug addiction epidemic.” They note that Zohydro “will kill people as soon as it is released.” Dr. Andrew Kolodny calls it “a whopping dose of hydrocodone packed in...
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Florida Workers' Compensation FIlings Continue to Decrease
Sunday, February 23, 2014
F.D.A. Orders 4 Bidi Cigarette Brands Removed From Shelves
The Food and Drug Administration on Friday ordered four tobacco products removed from the market, the first time the agency has done so since being given the legal authority in 2009.
“It’s a big deal,” said Matthew L. Myers, the president of the Campaign for Tobacco-Free Kids, an advocacy group. “This is first time the F.D.A. has ever ordered a product to be removed from the market for broad public health concerns.”
“It’s also significant that they did so because the manufacturer was unable or unwilling to provide sufficient evidence that the product didn’t raise new or different concerns for public health,” he added.
Since June 2013, the F.D.A. has rejected 13 new tobacco products because agency scientists believed they posed health risks above and beyond comparable products already on the market.
Agency officials said that four cigarette brands made by Jash International may no longer be domestically sold, distributed or imported. They are Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone and Sutra Bidis Menthol Cone. In 30 days, the F.D.A. will begin seizing any goods that remain on shelves.
The unconventional cigarettes are bidis — thin, hand-rolled cigarettes stuffed with tobacco, wrapped in leaves from a tendu tree and sometimes tied with a colorful string. Popular in India, bidis are not widely smoked here, but their novelty appeals to some adolescents.
In 2012, the Centers for Disease Control and...
[Click here to see the rest of this post]
“It’s a big deal,” said Matthew L. Myers, the president of the Campaign for Tobacco-Free Kids, an advocacy group. “This is first time the F.D.A. has ever ordered a product to be removed from the market for broad public health concerns.”
“It’s also significant that they did so because the manufacturer was unable or unwilling to provide sufficient evidence that the product didn’t raise new or different concerns for public health,” he added.
Since June 2013, the F.D.A. has rejected 13 new tobacco products because agency scientists believed they posed health risks above and beyond comparable products already on the market.
Agency officials said that four cigarette brands made by Jash International may no longer be domestically sold, distributed or imported. They are Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone and Sutra Bidis Menthol Cone. In 30 days, the F.D.A. will begin seizing any goods that remain on shelves.
The unconventional cigarettes are bidis — thin, hand-rolled cigarettes stuffed with tobacco, wrapped in leaves from a tendu tree and sometimes tied with a colorful string. Popular in India, bidis are not widely smoked here, but their novelty appeals to some adolescents.
In 2012, the Centers for Disease Control and...
[Click here to see the rest of this post]
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Jon L. Gelman of Wayne NJ is the author NJ Workers’ Compensation Law (West-Thompson) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thompson). 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.
Read more about "Smoking and Workers' Compensation:"
Jan 12, 2014
The 1964 U.S. Surgeon General's report on smoking — the first official acknowledgment by the federal government that smoking kills — was an extraordinarily progressive document for its time. It swiftly led to a federal law that ...
Jan 20, 2014
Despite the many gains in reducing risks over the past half-century, researchers keep finding new and insidious ways in which smoking is harming the smokers themselves and nonsmokers who breathe in toxic fumes.
Aug 14, 2013
City parks, public beaches, college campuses and other outdoor venues across the country are putting up signs telling smokers they can't light up. Outdoor smoking bans have nearly doubled in the last five years, with the tally ...
Dec 03, 2013
Smoking is a major pre-existing condition in workers' compensation claims and it is also a multiplier for medical conditions that result in malignancies. Penalizing smokers through the ACA (Affordable Care Act) will also have ...
Sunday, January 5, 2014
Video: AAJ President Discusses Generic Drugs
Nearly 80 percent of all prescriptions in the U.S. are filled with the generic version of a drug. The price tag can be appealing, but taking a generic drug can also have dangerous consequences because generic drug manufacturers are not accountable for the safety of drugs they produce.Accountability is a key incentive to ensure drug companies monitor and adequately warn patients about the safety of drugs. Despite what many may think, the FDA does not test drugs, but instead relies on testing provided by the drug companies. FDA approval of a drug does not guarantee safety. In the above video, American Association for Justice President Burton LeBlanc talks about the accountability imbalance between generic drugs and name-brand drugs and how the lack of accountability can put consumers at risk. “What you may not know is that unlike brand-name manufacturers, generic drug manufacturers cannot be held accountable if their drugs injure or kill Americans. And we all know too well, if no one is accountable, no one is safe,” LeBlanc said. To view the video in its entirety, click here. Here’s where you can help. Join the growing number of over 20,000 consumers who have already signed a petition calling on the FDA to restore accountability. Safety is an issue that can’t be overlooked.
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Monday, December 16, 2013
FDA challenges safety, effectiveness of antibacterial soaps
In many medical treatment scenarios antibacterial soaps have been used and prescribed to treat injured workers. The US FDA has announced that new procedures to substantiate the allegations of the manufacturers as to the effectiveness and safety of these products. Today's post is shared from cidrap.umn.edu
[Click here to see the rest of this post]
The US Food and Drug Administration (FDA) today proposed a rule that would require companies that make antibacterial hand soaps and body washes to show that the products are safe for long-term use and are better than regular soap and water in preventing illness and the spread of infections.
Under the FDA's proposal, manufacturers that don't demonstrate the safety and effectiveness would be required to reformulate the products or relabel them to remain on the market, the agency said in a statement today. The FDA detailed its proposal in a 130-page report posted in the Federal Register and is taking comments on it over the next 180 days. Today's rule proposal doesn't apply to hand sanitizers, wipes, or antibacterial products used in healthcare settings. The FDA's proposed rules are part of a broader effort to weigh the benefit and risks of certain active ingredients in antibacterial products, including triclosan in liquid soaps and triclocarban in bar soaps. Scientists have raised concerns about a possible role of widespread antiseptic use in the development of antibiotic resistance. The FDA said in... |
Thursday, December 5, 2013
FDA issues safety communication on HeartStart automated external defibrillators from Philips Healthcare
Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation, the U.S. Food and Drug Administration said today in a new safety communication for users of these previously recalled devices.
The safety communication includes recommendations to better inspect and monitor the readiness of these devices, as well as steps to follow if someone must use a recalled device in an emergency situation.
“If the device indicates it has detected an error during a self-test the FDA advises users to keep recalled HeartStart AEDs in service until a replacement from Philips Healthcare or another AED manufacturer is obtained,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “Despite current manufacturing and performance problems, the FDA considers the benefits of attempting to use an AED in a cardiac arrest emergency greater than the risk of not attempting to use the defibrillator.”
These devices were manufactured and distributed between 2005 and 2012 under the names HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite. Users, who may include consumers and first responders, should contact Philips Healthcare 
immediately for a replacement AED unit.
immediately for a replacement AED unit.
An AED is a device that automatically analyzes the heart rhythm in victims of sudden cardiac arrest and delivers an electrical shock to restore its normal rhythm. AEDs help save lives of cardiac arrest victims when they are working properly and used correctly. Each year, nearly 300,000 Americans collapse from sudden cardiac arrest. When normal heart rhythms are not restored quickly, sudden cardiac arrest can cause death.
In September 2012, Philips Healthcare initiated the recall of HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite AEDs due to the failure of an internal electrical component. The recall affected approximately 700,000 devices. In a Medical Device Safety Notice dated November 19, 2013, Philips provided consumers with updated information about the failure of an internal electrical component that could cause the AEDs to fail to deliver a shock. The notification also directed users to a Maintenance Advisory .
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The FDA will continue to closely monitor all AED manufacturers’ quality system practices and manufacturing changes that have persistently contributed to recall and adverse events associated with AEDs.
In March 2013, the FDA issued a proposed order that if finalized would require manufacturers of AEDs and accessories to submit premarket approval applications that focus specifically on the critical requirements necessary to assure AEDs are safe and effective. The main objective of this proposed regulatory approach is to improve the reliability of AEDs so that they can continue to save lives.
For more information:
- FDA Medical Devices
- FDA Safety Communication: Philips HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite Automated External Defibrillators (AED)
- FDA issues proposal to improve the quality of automated external defibrillators
- Philips Maintenance Advisory
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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Jon L. Gelman of Wayne NJ is the author NJ Workers’ Compensation Law (West-Thompson) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thompson). 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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