Johnson & Johnson Placing Warning on Sporanox Label

Johnson & Johnson said Wednesday that some reports of deaths among those taking its anti-fungal treatment Sporanox prompted it to warn that people with a history of congestive heart failure should not take the medicine.

Later, the Food and Drug Administration issued a statement estimating that Sporanox contributed to or caused 58 reported cases of congestive heart failure. Thirteen of the patients died, but the agency said “confounding factors” made any link between Sporanox and the deaths “very unclear.”

Ten of the 13 patients who died had “serious underlying conditions,” the FDA added.

J&J; said warning language is being added to the Sporanox packaging to say use of the medicine could aggravate or bring on symptoms of congestive heart failure.

A spokesman for J&J;’s Janssen Pharmaceutica Products unit said the label is being changed to reflect the danger after reports of deaths over the last few years.

“The drug could exacerbate the situation and could bring on symptoms,” Arbesfeld said.

The company believes that the drug is safe and knows of no other types of patients that might be restricted from taking the medicine, he said.