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Drugs
Black Box Drugs: What You Need to Know
...by consumers. For the most serious risks, the FDA steps in and orders a Black Box Warning. What “Black Box” Means In one sense, a black box warning (boxed warning)...
December 8, 2017
Author Curtis Weyant
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Drugs
New Invokana Black Box Warning Required by FDA
...warning labels on its diabetes drug Invokana, as well as variations of the drug sold under the brand Invokamet and Invokamet XR. Invokana Amputation Warning The new black box warning...
May 18, 2017
Author Curtis Weyant
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Concerta Lawsuits
...as of 2011. Black box warnings are the strictest warnings for prescription drugs to protect against the most severe risk or risks the drug may cause. Concerta’s black box warning...
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Drugs
How to Read Prescription Drug Labels
...box warning? If so, what does that warning mean for my individual medical and prescription situation? Understanding Black Box Warnings The FDA reserves its most serious warning, the boxed warning,...
January 10, 2019
Author Katy Moncivais, Ph.D.
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Drug Lawsuits
...black box warnings to ensure that consumers understand the risks. What should I do if I experience a side effect from a drug? If you or a loved one suffers...
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Pradaxa Lawsuits
...more than expected. 2013: Boehringer Ingelheim adds a black box warning about risks of prematurely discontinuing the drug, and an increased risk of spinal hematomas in some patients. 2014: The...
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Abilify Lawsuits
...Abilify. A black box warning is the most severe warning that the FDA can issue about a medication. The agency also required BMS to add additional information to Abilify’s medication...
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Tasigna Lawsuits
...being filed against Novartis focus on a specific number of serious complications that have been identified through medical studies of the drug. The FDA has required black box warnings for...
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Uloric Lawsuits
...CARES study were published in March 2018 in The New England Journal of Medicine. However, the FDA did not require Takeda Pharmaceuticals to add a black box warning about this...
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Drugs
Drug and Device Safety During the 2019 Government Shutdown
...vaping must also fall lower on the priority list than monitoring and publicizing dangerous drugs in need of additional safety warnings like the infamous black box warning. So the FDA...
January 8, 2019
Author Katy Moncivais, Ph.D.
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Products
Bayer Lawsuits Consumers Should Know
...Bayer to conduct additional studies on adverse events and safety of the device, followed quickly by the addition of a black box warning and required patient-physician decision checklist. The FDA...
January 3, 2019
Author Katy Moncivais, Ph.D.
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Gadolinium Lawsuits
...a new black box warning on labels for all gadolinium-based contrast agents informing patients, doctors, and others about the potentially deadly occurrence of NSF/NFD in patients with kidney problems. Read...
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Legal
Essure Recall Issued Ahead of Netflix Documentary
...top of previous actions taken by the regulatory agency in 2016 to add a black box warning to its label and require ongoing postmarket surveillance of the device’s safety and...
July 23, 2018
Author Curtis Weyant
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Drugs
Medications That Cause Depression Could Be a Bigger Problem Than First Thought
...mood symptoms, including thoughts of suicide. Due to their high risk of severe side effects, antidepressants often have black box warnings. Depression, like other mood disorders, is difficult to treat...
July 10, 2018
Author Curtis Weyant
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Drugs
Johnson & Johnson Lawsuits Every Person Should Know About
...than others, and as such the FDA now requires a black box warning on Risperdal stating that risk. Less severe side effects include headache, constipation, tiredness, and sexual problems. Eligibility:...
July 5, 2018
Author Curtis Weyant
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Essure Lawsuits
...late 2017. As a result, the FDA restricted sales of the device in April 2018. November 2016: The FDA required a black box warning be added to Essure device labels...
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Invokana Lawsuits
...drug. As a result, the FDA required a black box warning be added to the drug label. Many of the Invokana lawsuits against Janssen accuse the company of failing to...
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Risperdal Lawsuits
...or stroke. Death: According to a black box warning on the drug label, Risperdal increases the risk of death in elderly patients with dementia-related psychosis. Fewer lawsuits have been filed...
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Truck Accident Lawyer
...Electronic “black box” data GPS and communication systems data Expert witnesses Driver licensing and qualifications Driver training and driving history Documented hours of service Truck inspection and service records Drug...
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Xarelto Lawsuits
...ultimately determined that the faulty device did not significantly change the outcome of the trial. Summary of Xarelto Warning Label Updates August 2013: Black-box warning added about the increased risk...
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Drugs
Pradaxa vs Xarelto: Comparing the New Class of Blood Thinners
Until the last decade, the only option available for patients with nonvalvular atrial fibrillation to help control blood clots was Coumadin (also known as warfarin). While effective in...
January 25, 2018
Author Curtis Weyant
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Consumer Lawsuits
Why are people filing product, drug and medical device lawsuits? The products we use on a daily basis are covered by a number of safety regulations, meaning that...
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Drugs
$775 Million Xarelto Settlement for 25,000 Pending Lawsuits
...and lack of antidote rather than focusing exclusively on its potential selling points. The FDA required the addition of a black-box warning to Xarelto’s label informing patients and physicians of...
March 25, 2019
Author Katy Moncivais, Ph.D.
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