Blood-Thinner Pradaxa: What You Should Know
What does the maker of Pradaxa say?
In a statement issued by Boehringer Ingelheim Pharmaceuticals, the company says that "real-world studies are important to support understanding of the safety and effectiveness of approved medicines in routine clinical use."
It points to an FDA statement issued after the larger study, noting that Pradaxa is still considered to have more benefits than risks, and no changes have been made to recommendations for its use or to its label.
What do experts say about the findings?
Both of the new studies are observational, so they have built-in limitations compared to clinical trials, says Rita Redberg, MD. She's a professor of medicine at the University of California, San Francisco, and editor of JAMA Internal Medicine. When she looks at findings from both the clinical trials and the new observational studies, Redberg says, she thinks the ''overall risk-benefit ratio is more favorable on warfarin."
While she understands that patients like the convenience of not having to get regular blood tests on the newer drugs as they have to on warfarin, she says: "I am very concerned about the bleeding risk with the newer oral anticoagulants, and the fact that there is no reversal agent [to undo excess bleeding]."
She is talking about all three of the newer oral medicines, including Xarelto (rivaroxaban) and Eliquis (apixaban), although the recent studies focused on Pradaxa.
New guidelines on how to manage atrial fibrillation were released in March 2014 by the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society, in collaboration with the Society of Thoracic Surgery. In them, all three new oral drugs are viewed as options, with pros and cons. The benefits and risks sometimes vary by dosage, according to the guidelines.
The guidelines state that deciding whether to use warfarin or the newer blood thinners should be based on clinical factors, patient preference and costs, among other things. If someone is on warfarin and doing well, there is no need to switch, according to the guidelines.
People on the Pradaxa should ask their doctors about their risks and benefits, Redberg says.