Medications that are distributed to patients in the United States must undergo rigorous testing regulated by the U.S. Food and Drug Administration (FDA), which ensures the products are safe for consumers; however, medications are sometimes approved that can still be dangerous to consumers, including many blood thinners.

Take the well-known medication Pradaxa as an example. The anticoagulant drug is approved to help prevent blood clots in patients with atrial fibrillation, a heart condition that significantly increases the risk of stroke. Although the medication may potentially benefit patients in this regard, research finds that Pradaxa and other anticoagulants also have a high risk of bleeding and more uncontrollable bleeding complaints were filed with the FDA about Pradaxa than any other prescription drug in 2011 and 2012.

Investigation Reports Pradaxa Receives The Most FDA Complaints

Now, an investigation conducted by News Net 5 is showing Pradaxa to be one of the most problematic medications in the United States today. Their team found Pradaxa had been implicated in 1,158 deaths thus far. In addition, 12,494 patients allegdly suffered a serious Pradaxa bleeding event since its approval was issued four years ago, making Pradaxa the medication the FDA has received the most complaints about.

Documents were released that revealed the drug’s manufacturer, Boehringer Ingelheim Pharmaceuticals, performed a Pradaxa study that showed a small minority of patients could have a higher Pradaxa bleeding risk than others. One of Pradaxa’s main selling points is that the drug does not require regular blood tests to ensure it is working properly, but the same documents also showed that the company knew daily blood testing could help manage the potential Pradaxa bleeding risk, but did not notify consumers.

Additionally, news investigators reportedly found an internal email in which a supervisor expressed concern that requiring monitoring while taking Pradaxa could hurt Boehringer’s profits. The document allegedly questions whether the company should make Pradaxa bleeding information public, thus possibly undermining the company’s efforts to compete with other similar products.

Pradaxa Lawsuits

The FDA approved Pradaxa in 2010 and did not require regular monitoring in patients using this blood thinning medication, according to several Pradaxa lawsuits. Unfortunately, this could have been an opportunity to make the product safer.

Currently, the FDA is continuing to review Pradaxa side effects, as well as those of other anticoagulants, to evaluate the effectiveness and safety of the products, although the agency had initially maintained that Pradaxa and other blood thinner medications were equal in terms of bleeding risk.

Many of these reported problems have led to Pradaxa bleeding lawsuits being filed against the drug’s manufacturer. The latest allegations to emerge from the documents supplied through these Pradaxa lawsuits have shown the drug manufacturer may have concealed evidence of Pradaxa bleeding risks because of the negative impact the findings may have had on Pradaxa marketing.

If you or someone you love has suffered from adverse and life-threatening Pradaxa complications such as internal bleeding, you may be entitled to work with Pradaxa lawyers and file a Pradaxa lawsuit to recover damages for your conditions.