Pradaxa Warning Label Updated by Boehringer Ingelheim

The warning label for Pradaxa is being updated, indicating that patients who are at risk of stroke should not stop using the anticogulant without talking to their doctor first. The changes come amid continuing debate over the safety of the drug and concerns about Pradaxa bleeding risks in the scientific and regulatory communities.  

Boehringer Ingelheim announced that it is updating the Pradaxa warning label in a press release issued on April 30. Among the changes being made by the drug maker is the addition of a “black box” warning advising patients that discontinuing Pradaxa treatment places them at an increased risk of stroke. Other changes include updating information concerning data from a clinical trial comparing Pradaxa to warfarin and adding indications that users may face a risk of thrombocytopenia.

Pradaxa (dabigatran) was the first member of a  new class of anticoagulants, which was introduced in October 2010 as a stroke prevention alternative to warfarin, which is more commonly known as Coumadin. Boehringer Ingelheim has aggressively promoted Pradaxa as superior to warfarin, because it requires less monitoring. However, a concerning number of reports have been filed since the drug was introduced involving patients who suffered uncontrollable bleeding problems with Pradaxa.

During the first full year the drug was on the market in the United States, the Institute for Safe Medication Practices (ISMP) found that adverse event reports involving problems with Pradaxa surpassed all other medications regularly monitored by the group. 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.

Boehringer Ingelheim currently faces several hundred Pradaxa lawsuits filed on behalf of consumers who allege that the drug maker failed to adequately warn about the bleeding risk or the lack of a reversal agent for Pradaxa, which could allow doctors to control bleeding that may develop while the medication is used.

Unlike warfarin, which has a reversal agent that can be used to stop bleeding problems, Pradaxa has no antidote and doctors are often unable to reverse the blood thinning effects of the medication if a user develops a hemorrhage. This update to the Pradaxa label does not add any new information about the risk of uncontrollable bleeding or about the lack of a reversal agent.

Earlier this year the consumer watchdog group Public Citizen warned consumers not to use Pradaxa during the first seven years it is on the market, and to stick with warfarin until the risk profile of Pradaxa and its new competitor drugs Xarelto and Eliquis are better understood.

Following the release of the new label warnings, Public Citizen issued another statement last week in its Worst Pills Best Pills newsletter (Subscription Required) supporting the label warning and advising patients to keep taking the drug if they have already been placed on Pradaxa. However, they reiterated their recommendation that patients talk to their doctor about the risks and the possibility of switching to warfarin.