J&J; Limits Drug’s Use

Johnson & Johnson is telling doctors to limit use of its Natrecor heart-failure drug, which has been tied to a higher rate of deaths in studies, to patients whose symptoms are so severe that they’ve been hospitalized.

Sales representatives and promotional speakers will be trained specifically regarding Natrecor’s recommended use in the new informational campaign, the New Brunswick, N.J.-based company said Monday. The plan is part of J&J;’s response to recommendations from a panel of heart doctors that the company asked in April to review Natrecor.

Johnson & Johnson is issuing the advice, including a letter last month telling doctors to stop inappropriate use of Natrecor, as drug makers face scrutiny of their marketing practices from physicians, members of Congress and the public. J&J;’s marketing of Natrecor, the subject of a federal subpoena in July, led some doctors to overestimate the medicine’s value and failed to fully convey its risks, panel member Milton Packer said.

“The data does not support that it is as effective or safe as they have implied,” said Packer, a doctor at University of Texas Southwestern Medical Center.

Shares of J&J;, the maker of thousands of products including Band-Aids and birth control pills, fell 7 cents to $63.50.

Johnson & Johnson said July 20 that it had received a subpoena from the U.S. attorney’s office in Boston for documents related to its sales and marketing of Natrecor. Mark Wolfe, a spokesman for Johnson & Johnson, said Monday that the company wouldn’t comment further on the request.

The July 13 letter to doctors told them to stop inappropriate use of Natrecor as a diuretic or kidney treatment and urged them to use it as recommended for hospitalized patients.

The company in April revised Natrecor’s label to show that the combined results of seven studies found more deaths in patients who took the drug than in those who didn’t. The new label also says that six-month results found little difference between the two groups.

The Food and Drug Administration had been asking J&J; for months to change the Natrecor label, Robert Temple, director of medical policy in the agency’s Center for Drug Evaluation and Research, said in an April interview.

In May, Johnson & Johnson said an analysis of data from 65,000 patients who had taken Natrecor showed that the drug was safe. The findings were taken from a patient database.

The company’s recommendation that doctors limit use of the drug to patients in hospitals is more narrow than that specified on the medicine’s label. The FDA approved marketing of the drug for patients with acute heart failure who are breathless while resting or minimally active. Federal law allows doctors to prescribe approved medicines for other, so-called off-label, uses.