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J&J says two deaths unreported in Natrecor study

NEW YORK (Reuters) - Johnson & Johnson''s Scios Inc. unit on Tuesday said it had informed U.S. regulators that a previously unreported two additional patients died 30 days after taking its Natrecor heart failure drug in a long-term study, adding to uncertainty about the drug''s safety.

Sales of the medicine, known generically as nesiritide, have declined sharply due to safety concerns, but J&J has defended the medicine as a safe and useful treatment for patients whose weakened hearts are unable to adequately pump blood to other parts of the body.

The company on Tuesday said the two additional deaths in the study had not initially been reported to the company. The study, described in the 2005 October issue of the Journal of Emergency Medicine, indicated there was no statistical difference in the number of deaths among patients taking Natrecor and those taking placebos 30 days after treatment began.

Because the data did not include the two deaths that have now come to light, the diversified healthcare company said it is now attempting to determine whether Natrecor indeed poses no higher risk of death.

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