The side effects Xarelto story starts with initial approval in 2011, and the blood thinner has had an eventful journey, receiving several warnings from the U.S. Food and Drug Administration (FDA), as well as required labeling and advertising changes.
Xarelto is approved by the FDA for the treatment of deep vein thrombosis in patients undergoing knee replacement and hip replacement surgery, to reduce the risk of stroke in people with abnormal heart rhythm, and to treat and reduce the risk of deep vein thrombosis or pulmonary embolism.
Xarelto makers Janssen Pharmaceuticals (Johnson & Johnson subsidiary) and Bayer AG were required to make changes to their advertisements after the FDA claimed that the companies downplayed the possible side effects associated with the drug.
Xarelto was also required by the FDA to carry a boxed warning advising consumers and the medical community that premature discontinuation of the drug would increase the risk of thrombotic events and spinal/epidural hematoma.
The FDA issued five warnings and precautions regarding side effects Xarelto:
A side effects Xarelto boxed warning was issued by the FDA advising users of the dangerous side effects of Xarelto, including the lack of an antidote, and the risks associated with using the medication with epidural anesthesia and spinal puncture.
More label changes: the adverse reaction thrombocytopenia was added to the Xarelto label, and the adverse reaction term “cytolytic hepatitis” was replaced with “hepatitis.”
Side effects Xarelto moves from regulatory actions to lawsuits.
Since Xarelto’s approval five years ago, Xarelto Lawsuits have been filed against Johnson & Johnson and Bayer AG alleging Xarelto side effects including gastrointestinal bleeding, rectal bleeding, internal bleeding, stroke, heart attack, pulmonary embolism, epidural hematoma, and brain hemorrhages.
Some 2,800 cases have been consolidated into multidistrict litigation (MDL) in Eastern Louisiana and nearly 700 have been combined into a mass tort program in the state of Pennsylvania.
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Camp Lejeune’s water contamination issue spanned several decades starting in the 1950s. Exposure to these chemicals has been linked to various serious health issues, including cancer, organ diseases, and death.
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Legal action is being taken against manufacturers of Aqueous Film-Forming Foam (AFFF), a chemical used in fighting fires. The plaintiffs allege that exposure to the foam caused health issues such as cancer, organ damage, and birth and fertility issues.
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Consumers are advised that Feel Good Foods, of New York, New York, has recalled its Gluten-Free Cream Cheese Stuffed Mini Bagels in the Plain and Everything flavors due to the potential presence of undeclared gluten from cross-contamination. Individuals who live with an allergy or sensitivity
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