Report: FDA Overlooked Serious Risks When Approving Pradaxa

A Washington Pradaxa injury attorney notes an investigation from the Project on Government Oversight suggesting that the U.S. Food and Drug Administration (FDA) approved the anticoagulant Pradaxa without adequately assessing its safety profile or advising patients of its dangers. Affected patients and their families may be eligible to file a lawsuit and recover compensation for their injuries with the assistance of Pradaxa attorneys.

For more information, contact Attorney Group for Washington. We offer free, confidential, no obligation consultations. We can help answer your questions, and if you choose to pursue a case we can connect you with an affiliated Washington Pradaxa injury attorney who can assist you throughout the legal process.

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Warning Labels Advising Patients of Life-Threatening Bleeding Events Not Required

A review of the FDA’s approval of the anti-clotting drug Pradaxa indicates that the agency may have looked past warning signs that the drug could endanger patients and allowed the drug to be presented in a misleading light. As The New Haven Register reports, the FDA approved Pradaxa on the basis of a single “un-blinded” clinical trial that could have biased the final results to make the drug appear safer and more effective. Although the FDA reportedly knew that aspects of the trial had been mismanaged, it still ultimately green-lighted Pradaxa.

The investigation also suggests that the FDA didn’t take adequate steps to make the risks associated with this drug known to users. Although Pradaxa lacks an antidote, potentially leading to uncontrollable bleeding events, the FDA didn’t require a “black box” warning label to advise patients of the risk of irreversible, life-threatening bleeding events. This flawed approval and marketing of Pradaxa has reportedly affected countless people. In 2014, Pradaxa’s maker settled roughly 4,000 state and federal lawsuits in which plaintiffs allegedly suffered serious injuries or lost loved ones due to the drug’s dangerous side effects.

How a Washington Pradaxa Injury Attorney Can Help

Drug makers have a duty to provide safe products. If there are risks of harm associated with their products, they also must provide adequate warnings. If a drug maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.

People injured by bad drugs may be eligible to recover money for:

  • Medical Expenses
  • Lost Wages
  • Pain and Suffering

The families of those who have died may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.

The Time You Have to Pursue a Claim is Limited. Contact Us Today.

For more information, contact Attorney Group for Washington. You can fill out the form on this page or contact us by phone or email.

After you contact us, an attorney will follow up to answer questions that you might have. There is no cost or obligation to speak with us, and any information you provide will be kept confidential.

Please note that the law limits the time you have to pursue a claim or file a lawsuit for an injury. If you think you have a case, you should not delay taking action.