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By: Irvin Jackson | Published: April 4th, 2013
The prominent watchdog group Public Citizen is warning consumers to stay away from a new class of anticoagulants that includes Pradaxa and Xarelto, indicating that there is increasing evidence of severe bleeding issues with the drugs and a lack of information to establish that they are superior to warfarin, which has been the go-to stroke prevention medication for decades.
In the latest edition of the group’s Worst Pills, Best Pills newsletter (subscription required), Public Citizen highlights how doctors are reporting an increasing number of bleeding problems with Pradaxa and Xarelto, which they sometimes cannot stop because these new drugs lack a reversal agent to counteract their blood thinning effects.
The newsletter points out that while the makers of Pradaxa (dabigatran) and Xarelto(rivaroxaban) claim the drugs are better to use than warfarin, because they are easier and require less monitoring, bleeding events that do occur could be more dangerous.
“All anticoagulants used in stroke prevention, including the traditional treatment of warfarin, carry bleeding risks. However, the anticoagulant effects of warfarin can be quickly reversed using vitamin K, blood plasma and/or clotting agents. It also is relatively easy to measure the levels of warfarin in the blood,” the newsletter states. “In sharp contrast, there is no simple treatment known to reverse the adverse effects of dabigatran or the other similar new longer-acting agents, and no available test can accurately measure the levels of these drugs in the blood.”
Public Citizen warns that elderly patients or those with kidney or liver problems may be at higher risk due to their body’s inability to remove the drugs from their system, which could lead to it building up and increasing the risk of bleeding events. The group points out that no clinical trials have been conducted that provide doctors with accurate dosing guidance for these patients.
“Avoid starting dabigatran or rivaroxaban if you are being prescribed an anticoagulant for the first time, and do not switch to these drugs if you are taking warfarin,” Public Citizen warns. “Although one or more of the new anticoagulants may eventually be used safely and effectively in clinical practice (if the right tests and antidotes can be developed), at present they clearly carry risks, and too little is known about them at this time to abandon warfarin as the trusted alternative.”
Public Citizen does point out that consumers should never stop taking a medication without speaking with their doctor, which is particularly important with anticoagulants, which could increase the risk of a stroke if stopped suddenly. Individuals already prescribed Pradaxa or Xarelto have been urged to talk to their doctors about how to watch for potential signs of bleeding problems.
Pradaxa (dabigatran) is the most widely used of the two drugs for prevention of strokes, being the first member of the class of drugs to reach the market in October 2010. However, shortly after it was introduced by Boehringer Ingelheim, it quickly became one of the drugs most commonly associated with adverse event reports submitted to the FDA.
During 2011, the first full year the drug was on the market, the Institute for Safe Medication Practices (ISMP) found that adverse event reports involving Pradaxa problems surpassed all other medications regularly monitored by the group. The FDA received at least 3,781 reports involving serious injuries associated with the use of Pradaxa during 2011, including 2,367 reports of hemorrhage and 542 patient deaths.
About 200 Pradaxa bleeding lawsuits have been filed against Boehringer Ingelheim, alleging that the drug maker failed to adequately warn about the risk of serious or fatal health problems and the lack of a reversal agent to stop bleeding problems that may develop.
In the federal court system, the Pradaxa litigation is centralized before U.S. District Judge David R. Herndon as part of an MDL, or multidistrict litigation. A case management plan has been established where a handful of cases are being prepared for early trial dates, which are expected to go to trial in August 2014. Judge Herndon has also ordered the parties to meet every month starting in August 2013, to discuss potential Pradaxa settlement agreements.