The U.S. Food and Drug Administration today announced that it is working with the maker of Xigris (drotrecogin alfa activated), Eli Lilly and Company, to further evaluate the incidence of serious bleeding events and death in patients who receive Xigris, a drug used to treat severe sepsis (a blood stream infection).
A recent study and an accompanying editorial published in the journal Critical Care Medicine reported an increased risk of serious bleeding events and death in patients with sepsis and baseline bleeding risk factors who received Xigris. The study, a retrospective review of medical records of 73 patients who were treated with Xigris, found that serious bleeding events occurred in seven of 20 patients (35 percent) who had a bleeding risk factor versus two of 53 (3.8 percent) of patients without any bleeding risk factors. More patients with baseline bleeding risk factors died (13 of 20, or 65 percent) compared with patients without any bleeding risk factors (13 of 53, or 24.5 percent). As noted by the authors, limitations of this study include the retrospective design (looking back at events that already have taken place) and small patient population.
Xigris is known to increase the risk of bleeding. The drug’s current prescribing information (labeling) includes a warning that describes bleeding as the most common serious adverse effect and lists a number of risk factors that should be carefully considered when deciding whether to use Xigris. The labeling contraindicates the use of Xigris in several clinical situations where bleeding could lead to significant adverse reactions or death.
The FDA is not recommending that prescribers stop administering this medication. Consumers and health care professionals should notify the FDA of any complaints or problems associated with this product. These reports may be made to MedWatch, the FDA’s voluntary reporting program, by calling 800-FDA-1088, or electronically at www.fda.gov/medwatch/report.htm.
-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
No comments:
Post a Comment
We do not publish all comments, and we may not publish comments immediately.
Constructive debate, even opposing views, are welcome, but personal attacks on other commenters or individuals in the article are not, and will not be published.
We will NOT post any comments with LINKS, nor will we publish comments that are commercial in nature.
We will not publish comments that we deem to be obscene, defamatory, or intended to incite violence.