Clinical trials are intended to protect the general public by determining whether a medication is actually effective and whether it has any drastic side effects. Patients in Texas and across the rest of the United States rely on these trials and the approval of the Food and Drug Administration to keep defective drugs off of the market. However, the validity of a clinical trial used for a popular blood thinner and heart drug has recently been called into question.
Rivaroxaban -- also known by Xarelto, its brand name -- has been prescribed upwards of 13 million times and is the most popular blood thinner of its class to date. Its clinical trial involved 14,000 patients and concluded that Rivaroxaban was effective at preventing systemic embolisms, a serious condition caused by blood clots that obstruct the blood vessels. A second drug, Warfarin, was also included in the trial, and the results indicated that both drugs carried about the same risk of causing a major bleed. However, while the overall risk of major bleeding was the same, those taking the Rivaroxaban group were less likely to experience fatal bleeding.
The results might have once sounded promising, but there are some individuals who are now skeptical. A device that played an integral role in the study ended up being recalled for being faulty and ineffective. While the research institute that performed the study released a statement indicating that further analysis confirmed their initial results, others have called for an independent review and investigation of the trial.
When the safety and efficacy of a drug on the market is called into question, it is important for researchers and the FDA alike to take a renewed interest in the medication. Defective drugs pose serious risks to Texas patients who might otherwise be unaware of the possible damage that is going on inside of them. Unfortunately, instances can and do arise when dangerous medications make it to the market and seriously injure patients. In these events, victims are often able to recover compensation for their injuries from the manufacturer.
Source: CBS, "Questions raised about clinical trial of heart drugs rivaroxaban (Xarelto) and warfarin", Mary Brophy Marcus, Feb. 3, 2016