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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
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Invokana Loses the Black Box Amputation Warning, But Fournier's Gangrene Risk Still Looms
In late 2020, the U.S. Food and Drug Administration (FDA) removed a Boxed Warning from the Invokana drug label. The black box warning was added in 2017 when regulators learned...
March 18, 2021
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Concerta Lawsuit
...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 is...
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Lisinopril Lawsuit
...a black box warning for Prinivil, Zestril, and other drugs containing lisinopril. Lisinopril Black Box Warning WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is...
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Does Uloric Cause Heart Attacks?
Uloric has been in the headlines recently due to an announcement by the U.S. Food and Drug Administration (FDA) in February that a new black box warning was being added...
May 8, 2019
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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
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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 Lawsuit
...reports of serious bleeding events to determine whether such incidents were occurring more than expected. 2013: Boehringer Ingelheim adds a black box warning about risks of prematurely discontinuing the drug...
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Tasigna Lawsuit
...required black box warnings for some of these side effects, including the risk of sudden death and QT prolongation. Severe Tasigna Side Effects Some of the dangerous Tasigna side effects...
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Abilify Lawsuit
...gambling, eating, shopping, or sexual behaviors by patients taking Abilify. A black box warning is the most severe warning that the FDA can issue a medication. The agency also required...
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Essure Lawsuit
...there are any heightened risks of Essure for certain women, based on adverse event reports filed to the agency. November 2016: The FDA required a black box warning be added...
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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
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Xarelto Lawsuit
...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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Bayer Announces Settlement Signaling The End for Essure Lawsuits
...Created Legal Problems for Bayer The Essure Facebook group boosted media coverage of device side effects. As a result, the FDA increased scrutiny of the device, eventually putting a black...
September 16, 2020
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Big Pharma: When Wealth Trumps Wellness
...received more reports of deaths and serious side effects due to Pradaxa than any other regularly monitored medication. Three years later, the FDA required a black box warning for Pradaxa,...
September 3, 2020
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Uloric vs Allopurinol
...when the drug gained a black box warning in early 2018. Uloric has since been relegated to second-line treatment status, only prescribed to patients for whom allopurinol has failed. This...
July 11, 2019
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Uloric Lawsuit
...2018 in The New England Journal of Medicine. However, the FDA did not require Takeda Pharmaceuticals to add a black box warning about this dangerous side effect until February 2019....
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Bayer Lawsuits Consumers Should Know
...the device, followed quickly by the addition of a black box warning and required patient-physician decision checklist. The FDA restricted the sale of the device after receiving more than 26,700...
January 3, 2019
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Truck Accident Lawyer
...the damaged vehicles Tire and skid marks on road surfaces Witness statements Dashcam video footage Electronic "black box" data GPS and communication systems data Expert witnesses Driver licensing and qualifications...
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Risperdal Lawsuit
...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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Johnson & Johnson Lawsuits Every Person Should Know About
...patients with dementia are at an even higher risk of death than others, and as such the FDA now requires a black box warning on Risperdal stating that risk. Less...
July 5, 2018
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Essure Recall Issued Ahead of Netflix Documentary
...the many possible side effects of the contraceptive. This is on top of previous actions taken by the regulatory agency in 2016 to add a black box warning to its...
July 23, 2018
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Medications That Cause Depression Could Be a Bigger Problem Than First Thought
...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 because it...
July 10, 2018
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Gadolinium Lawsuit
...» May 2007 - The FDA requested that drugmakers add a new black box warning on labels for all gadolinium-based contrast agents informing patients, doctors, and others about the potentially...
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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 preventing intracranial...
January 25, 2018
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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 companies must...
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$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
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