FDA Asks SuperGen to Halt Misleading Marketing of Nipent
Company materials omit risks, exaggerate safety, says federal agency
THURSDAY, Sep. 1 (HealthDay Professional Briefing) -- The U.S. Food and Drug Administration warned SuperGen in a recent letter to stop disseminating "false or misleading" information about the company's leukemia drug Nipent (pentostatin).
Company panel and handouts describing the drug's mechanism of action "fail to present any risk information for Nipent," according to an August 18 letter to SuperGen CEO James Manuso. SuperGen's promotional materials also make an unsubstantiated claim about Nipent's mechanism of action, and "overstate the safety and efficacy of the drug," according to the FDA letter.
Nipent is used to treat hairy-cell leukemia, but the FDA letter says there is no substantial data to back claims in SuperGen's promotional materials that Nipent works in a "unique" way. And the drug's label omits critical risk information, including "severe renal, liver, pulmonary and CNS toxicity at higher doses," and fatal lung toxicity when taken with the drug fludarabine, the FDA letter says.
The FDA also sent letters in 1997 and 2001 to SuperGen regarding the marketing of Nipent.