A recently published report states that a study that involved Xarelto was so badly managed that the FDA rejected it outright during its approval process. Nevertheless, the drug ultimately did somehow obtain approval from the FDA for use in the United States. This anticoagulant medication entered the American marketplace in 2011. The report’s analysis of the Xarelto study at issue is part of a larger look at the problems that allegedly exist with regards to problematic data not being published in studies. In addition, the study found that a large percentage of the FDA’s clinical trial inspection records are filled with redacted words and information that has been removed.
A link to the article, which appeared recently in JAMA Internal Medicine, can be found here. With regards to the study focusing on Xarelto, the information provided was not positive. The study at issue was known as RECORD 4. The FDA found it to be so filled with potentially erroneous information and other problems that it rejected the study altogether. The report linked above mentions several specific problems with the study, including:
- Systemic discarding of medical records
- Unauthorized unblinding
- Falsification
- Concerns regarding improprieties in randomization
Despite these findings by the FDA, the study was still published in medical journals in 2009 without mention of any of the problems uncovered. The rejection of the study by the FDA was also absent from publications. It should also be noted that the redactions mentioned with regards to other clinical studies above did not include the RECORD 4 study, which was openly described by the FDA as extremely problematic.
What This All Means
The message that’s clearly sent by this report can be described as follows:
- A large number of clinical studies submitted to the FDA during trials contain serious errors.
- Despite these errors, many of these drugs are still approved for use by the FDA.
- The RECORD 4 study was notorious for its problems and errors.
- Somehow, Xarelto was still approved for use in the United States by the FDA.
In essence, what the report seems to suggest is that just because a medication is approved by the FDA, that doesn’t mean that there aren’t potential risks associated with using many of them. Xarelto appears to be no exception to this problem.
Xarelto Lawsuits and Your Legal Rights
All of this information could prove to be relevant in any of the ongoing Xarelto lawsuits currently in American court systems. Xarelto is a blood thinner that was seen as an innovation when it hit the market, but reports of problems soon began to surface. These problems included the potential for patients to suffer internal bleeding. In addition, there is no known reversal agent for Xarelto, making these internal bleeds that much more dangerous when they arise.
If you or someone you love has been harmed as a result of using this medication, you need to contact the Xarelto side effects lawyers at Parilman & Associates today to schedule a free initial consultation. You can either email the firm or call 800-800-DRUG.
