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Natrecor label changed to show death risk

After two studies that clearly showed that the label Natrecor did not warn about the serious side effects of Natrecor, Johnson & Johnson, the manufacturer, has decided to change the label. Links to previous studies are below:

Natrecor increases risk of death

Natrecor damages kidney but no recall yet

The label change was approved last week by the Food and Drug Administration (FDA) and the information is now available on the company's website though no press release was issued to make consumers aware of the risks. The label shows a chart with data pooled from seven studies and the clear message is that 5.3% of people die when they took Natrecor compared to just 4.3% in a control group. However, the company argues that the data is not conclusive. It says on the insert, "There were few deaths in these studies, so the confidence limits around the hazard ratios for mortality are wide. The studies are also small, so some potentially important baseline imbalances exist among the treatment groups, the effects of which cannot be ascertained."

The label change does not necessarily amount to a warning and is definitely nowhere close to a drug recall.