British Medical Journal Investigation Concludes Pradaxa Maker Withheld Important Information From Regulators, Notes Rottenstein Law Group LLP

August 05, 2014 (PRLEAP.COM) Business News
August 5, 2014 - The Rottenstein Law Group, a national personal injury law firm that represents persons who believe they were injured by anticoagulants such as Pradaxa ( and Xarelto (, has learned that The BMJ has concluded that the maker of Pradaxa withheld from regulators important analyses regarding how to use the drug safely.

According to an article posted on its website, The BMJ announced this conclusion on July 23, 2014: "Boehringer Ingelheim, the maker of dabigatran [Pradaxa], has failed to share with regulators information about the potential benefits of monitoring anticoagulant activity and adjusting the dose to make sure the drug is working as safely and effectively as possible. The company also withheld analyses that calculated how many major bleeds dose adjustment could prevent. The company says that this information was not shared because the analysis did not provide a reliable prediction of patient outcomes."*

"If the conclusion of The BMJ is correct," said Rochelle Rottenstein, principal of the Rottenstein Law Group, "this is very troubling. Manufacturers of medicines must be forthcoming about the dangers of their products, or else patients will be needlessly harmed. Our goal is to make it as easy as possible for anyone possibly harmed by a drug to learn about the possible dangers and about legal options for demanding compensation for injuries suffered."

In 2013, the U.S. FDA received several hundred adverse event reports submitted by individuals who claimed to have a serious adverse side effect while taking Xarelto (rivaroxaban) (, as compared to a lower number for Pradaxa (dabigatran).** Data show that the number of persons being prescribed these blood thinning drugs is estimated at about 4 million for the year, with Xarelto prescriptions outnumbering Pradaxa prescriptions by two-to-one.** Anticoagulants (or "blood thinners") are considered high-risk prescription drugs because they can cause excessive internal bleeding and other injuries in some patients.

Anyone needing more information about the dangers of Xarelto should visit the firm's Xarelto site, where everything is explained in clear, concise language. Representatives of the firm are available to answer any questions, and there is a confidential, no-cost claim evaluation form that can be filled out in order to determine if there are grounds to file a Xarelto lawsuit.


The Rottenstein Law Group LLP is a New York-based firm that represents clients nationwide in mass tort actions. The firm was founded by Rochelle Rottenstein, who has more than two decades of experience as a lawyer, to represent clients hurt by defective medical devices and medications. (Attorney advertising. Prior results do not guarantee a similar outcome.)

The Rottenstein Law Group LLP
Rochelle Rottenstein, Esq.
100 Merrick Road
Suite 226W
Rockville Centre, NY 11570
(212) 933-9500 (office phone)
(212) 933-9980 (facsimile)
rochelle (at) rotlaw (dot) com

Share Article