Rottenstein Law Group Responds to FDA Report About ‘Heightened Sensitivity’ Over Pradaxa Side Effects

The Rottenstein Law Group, a Pradaxa law firm, acknowledges that the FDA has conducted extensive research into the topic, but the firm is still actively monitoring reports of side effects and filing lawsuits on behalf of clients who believe that Pradaxa injured them.

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...It does not change the fact that we receive dozens of calls a week from people who have suffered from the dangerous bleeding side effects associated with Pradaxa.

(PRWEB) March 15, 2013

Although there have been numerous Pradaxa lawsuits because of the anticoagulant drug’s alleged excessive bleeding side effects, the U.S. Food and Drug Administration issued a report* this week indicating that those effects are over-reported and that Pradaxa does not cause more bleeding than warfarin.

The Rottenstein Law Group, a Pradaxa law firm, acknowledges that the FDA has conducted extensive research into the topic, but the firm is still actively monitoring reports of side effects and filing lawsuits on behalf of clients who believe that Pradaxa allegedly injured them.

“If a drug is, in fact, harmful, or if a manufacturer hides the harms from the public, then these facts will come out in litigation—if not sooner,” said Rochelle Rottenstein, principal of the Rottenstein Law Group, responding to the report published in the New England Journal of Medicine.**

The Rottenstein Law Group represents clients who believe they have been harmed by Pradaxa and encourages people to visit the firm’s Pradaxa lawsuits page on its website and to download a free brochure to help them determine if they have a case.

According to Forbes, the FDA specialists who wrote the journal article discussed a notable difference between clinical trial findings and postmarketing reports: The trials found no difference in bleeding incidents between the Boehringer Ingelheim-made Pradaxa or long-time generic anticoagulant drug warfarin, however the FDA Adverse Event Reporting System received a high number of reports of bleeding incidents for Pradaxa.

“The FDA is essentially saying that people were more likely to report Pradaxa side effects than warfarin side effects because Pradaxa is a newer drug,” Rottenstein said. “The regulators are attributing this to patients and physicians exercising more vigilance about a new drug. However, it does not change the fact that we receive dozens of calls a week from people who have suffered from the dangerous bleeding side effects associated with Pradaxa.”

*forbes.com/sites/larryhusten/2013/03/13/fda-officials-calm-concerns-over-excessive-bleeding-with-pradaxa/

**nejm.org/doi/full/10.1056/NEJMp1302834?query=featured_home

About THE ROTTENSTEIN LAW GROUP
The Rottenstein Law Group 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. (Attorney advertising. Prior results do not guarantee a similar outcome.)

Contact:
The Rottenstein Law Group, LLP
Rochelle Rottenstein, Esq.
321 W. 44th Street
# 804
New York NY 10036
(212) 933-9500 (office phone)
(212) 933-9980 (facsimile)
rochelle (at) rotlaw (dot) com
http://www.rotlaw.com