Will Pradaxa Be Recalled From The Market Due to Safety Concerns?
Although it was just introduced in October 2010, substantial concerns have surfaced over the safety of Pradaxa amid reports of severe bleeding events and deaths.
While some have speculated that a Pradaxa recall should be issued to remove the new blood thinner from the market, there is no immediate indication that such a regulatory action is likely to occur.
Pradaxa (dabigatran) has been heavily marketed by Boehringer Ingelheim as a superior alternative to Coumadin, or warfarin, which caused the drug to quickly become widely used to prevent strokes among patients suffering from atrial fibrillation. However, concerns have emerged about Pradaxa safety, as it appears to carry a greater risk of gastrointestinal bleeding, hemorrhages and other potentially life-threatening concerns than was originally indicated on the drug’s warning label.
In December 2011, the FDA issued a drug safety communication to indicate that the agency is now evaluating post-marketing reports of serious bleeding events, raising speculation that the agency may recommend a recall for Pradaxa or other regulatory actions.
Concerns have also been raised by medical experts, who have questioned the validity of pre-market clinical trials used to gain approval to market Pradaxa in the United States. The trial used a double-blind method of comparing two doses of Pradaxa, but a non-blinded comparison between Pradaxa and Coumadin (warfarin), which independent researchers have suggested may have allowed bias and erros to creep into the results. Therefore, it has been suggested that Pradaxa was prematurely approved.
During the first 18 months Pradaxa was on the market in the United States, it was associated with an alarming number of severe bleeding events and deaths.
According to a May 2012 report (PDF) by the Institute for Safe Medication Practices (ISMP), there were at least 3,781 adverse event reports submitted to the FDA during 2011 involving serious Pradaxa problems, including 2,367 reports of hemorrhages or bleeds 644 reports of stroke, 291 reports of kidney failure and 542 patient deaths on Pradaxa. This far eclipsed the reports of bleeding problems associated with warfarin (which was number 2 on the list with 1,106 total adverse event reports), even though Pradaxa was introduced as a superior alternative to the older and more widely used medication.
The safety concerns surrounding Pradaxa also extend beyond bleeding problems. In January 2012, a study was published in the Archives of INternal Medicine that looked at a number of Pradaxa clinical trials and found that there may be an increased risk of heart attacks from Pradaxa when compared to patients who took other blood thinners.
Despite all of the substantial Pradaxa concerns, it appears unlikely that the FDA or drug maker intend to immediately recall the medication from the market. It appears more likely that new warnings will be required. However, sales are expected to drop substantially, as doctors may keep their patients off of the medication even if Pradaxa is not recalled.
In late May 2012, European drug regulators issued a statement following their review of the medication, indicating that they are not recommending a recall for Pradaxa because the benefits provided by the medication may outweigh the risk for some users. However, the European Medicines Agency (EMA) did recommend that stronger warnings be placed on the medication and that additional guidance be provided for consumers and the medical community about the bleeding risk.
PRADAXA RECALL LAWSUITS
A growing number of individuals throughout the United States have filed a Pradaxa lawsuit, with many alleging that Boehringer Ingelheim should remove Pradaxa from the market. However, even if the medication is not recalled, stronger warnings should have been provided when the medication was introduced about the risk of serious and potentially life-threatening Pradaxa side effects.
Pradaxa warnings and product inserts did not adequately reflect the extent of the risk faced by users of the medication. As a result, financial compensation may be available for individuals who have experienced an injury as a result of the drug makers failure to issue a recall for Pradaxa or provide adequate warnings.