Natrecor recall demanded again

No matter how hard Scios, the maker of Natrecor, works to keep the drug off the radar screen of scientists who doubt its safety, the medical community is not giving up. The FDA, which generally supports drug firms, has essentially ignored pleas so far from physicians and has refused to act. Natrecor has been found to damage the kidneys. Another separate study found that Natrecor increased the riks of death as well.

Many scientists are hoping that with Lester Crawford gone from the FDA, things might improve at the Agency. Writing in the New England Journal of Medicine, Dr. Jonathan Sackner-Bernstein says, "This is a terrific litmus test to see whether he is really concerned about the safety of drugs that are on the market." In April, Scios merely changed the label on Natrecor. As it was learned that Natrecor was being given to patients in cases where its safety was not tested (because the doctors benefited from every prescription), the prescription guidelines were changed.

Dr. Eric J. Topol, one of the early critics of now recalled painkiller Vioxx, has fought for the recall of Natrecor for years. He demanded that Natrecor be withdrawn in another previous article. At a showdown at the Cleveland Clinic where he works, Natrecor was almost banned at the hospital. "With all the leadership strife at FDA and the unwillingness of those people who were involved to admit the potential of being too lenient [in approving the drug], I'm not optimistic," he writes in the latest issue of the Journal.