Sirolimus is indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving kidney transplants. It belongs to a class of macrolide antibiotic compounds and is isolated from the organism Streptomyces hygroscopicus. The safety and efficacy of this drug in patients who have undergone liver or lung transplantation have not been established by the FDA.
The FDA is determining whether a labeling change will be necessary for sirolimus, according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program. "The Agency will continue to examine the data on mortality and other adverse events in this study, and will make further recommendations, as appropriate," the FDA said.
In the interim, the FDA recommends that transplantation physicians continue to use the drug's professional labeling as a guide to therapy. The FDA points out that they have not concluded a causal relationship between the drug and the emerging safety issue, and the agency is not advising healthcare professionals to discontinue prescribing sirolimus at this time. As they become available, further safety information or analyses on sirolimus will be released, the FDA added.
The decision to issue the alert was based on clinical trial data that the FDA received from the drug's manufacturer on March 29, 2009, indicating an increased mortality risk in patients converted from a CNI-based immunosuppressive regimen to sirolimus compared with those who remained on the CNI-based regimen.
Any adverse events associated with sirolimus should be communicated to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.
0 comments:
Post a Comment