An Overview Of FDA Warnings Leading Into Building Xarelto Lawsuit Numbers

March 29, 2016 – – BloodThinnerHelp.com reports on the warnings issued by the FDA for the blood-thinning drug Xarelto since its approval in 2011. According to the FDA, Xarelto, manufactured by Johnson & Johnson and Bayer AG, has undergone several required warnings and changes to labeling and advertisements for the drug since it was approved.

From January to March 2014 the manufacturers were required by the FDA to make changes to the language on the “black box warning” on the drug. The addition was allegedly needed to warn users about dangerous side effects including a lack of antidote and the risks associated with using the drug with epidural anesthesia and spinal puncture.

The companies had to make changes to their advertisements after the FDA claimed that the companies downplayed the possible side effects associated with the drug. From May to November of 2012 the FDA Cardiovascular and Renal Drugs Advisory committee convened to discuss the possibility of extending Xarelto’s uses, according to the FDA. Though the committee decided not to approve the drug because of concerns about bleeding, the FDA expanded the use indicating in a press release that three studies indicated that the drug was safe for treatment of deep vein thrombosis and pulmonary embolism. The announcement also noted bleeding as a possible “major side effect.”

The companies also received post market requirements from the FDA including providing a low-dose tablet, conducting a clinical study to determine risks affiliated with renal impairment and to track “risk factors, clinical management and outcomes of all major bleeding events and to report them through a quarterly report for three years.”

Since the drug hit the market in 2011, thousands of lawsuits have been filed federally against the manufacturers by plaintiffs claiming the drug caused adverse side effects such as gastrointestinal bleeding, rectal bleeding, internal bleeding, stroke, heart attack, pulmonary embolism, epidural hematoma and brain hemorrhages. Those cases have been consolidated into a multidistrict litigation panel in Eastern Louisiana that has now reached 2,800 cases. Those filed in state court in Pennsylvania have been combined into a mass tort program that has reached 620 cases. Bellwether trials on federally-filed cases are scheduled to begin in February 2017.

Until those cases are brought to court, Attorney Joseph Osborne is working to ensure that those individuals who have used the drug and have been negatively affected are able to explore their legal rights. Qualifying individuals may be entitled to financial compensation and legal action. Osborne is currently offering free legal consultations for affected parties.

For more information about Xarelto, or to ask questions, contact Joseph Osborne, Esq. by calling (866) 425-8902.

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Contact BloodThinnerHelp.com:

Joseph Osborne
866-425-8902
Mizner Park
433 Plaza Real Blvd., Ste. 271
Boca Raton, FL 33432

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