Scios Final Analysis Of Natrecor Trial Finds Two Additional Deaths
This article was originally published in The Pink Sheet Daily
Johnson & Johnson subsidiary maintains the additional deaths have “no impact on overall risk/benefit profile” of the heart failure therapy.
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The J&J subsidiary says the deaths have “no impact on the overall benefit/risk profile” of the heart failure drug when it is prescribed as labeled.
FDA does not believe a "Dear Doctor" letter or advisory committee review are warranted at this time. The new labeling reports 30-day and 180-day mortality risks for Natrecor compared to active controls in all randomized trials of the CHF therapy.
The company is in discussions with FDA to “ensure that correct conclusions are in label.” Adverse publicity from Circulation article questioning kidney safety of CHF drug is having an impact; mortality analysis in JAMA will raise more questions.