Experimental HIV Medicine Raises FDA Questions About Kidney Damage.

Bloomberg News  (5/10, Flinn, Pettypiece) reports that the experimental medicine Quad (elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate), made by Gilead Sciences, Inc. for the treatment of HIV, "may need additional monitoring because of kidney damage seen in studies," Food and Drug Administration staff said yesterday in a report released ahead of a May 11 advisory panel meeting on whether to approve the medication. "The agency asked advisers whether patients taking the drug should undergo extra testing to monitor for kidney complications." Specifically, "side effects included four cases of kidney failure and one case of a rare syndrome where substances aren't absorbed into the blood stream by the kidneys." Bloomberg BusinessWeek  (5/10, Flinn, Pettypiece) reprises the Bloomberg News article.

        Reuters  (5/9, Morgan) reported that the staff report did find that the medication seems to be effective. The report pointed out, however, that because the drug was tested only on a limited number of women, safety precautions may not be complete. The agency is expected to issue a final decision on the drug's approval no later than August 27.