Janssen, Pfizer, Schering Cited for Misleading Drug Claims

NEW YORK (Reuters Health) Aug 03 - The US Food and Drug Administration (FDA) this week made public on its Web site recent letters to the Janssen Research Foundation, Pfizer and Schering-Plough highlighting false and/or misleading statements made by the companies in promoting their drugs.

In the letter to the Janssen Research Foundation, the FDA said that at this year's American Society of Health-System Pharmacists meeting, a company representative failed to present the hepatic and cardiac risks associated with Sporanox (itraconazole) while promoting the anti-fungal medication.

The agency cited Pfizer for a "slim jim" brochure that made misleading claims regarding improvements in quality of life associated with the anticonvulsant Neurontin (gabapentin).

In its letter to Schering, the FDA said that a company representative falsely stated that survival rates with brain cancer drug Temodar (temozolomide) were compared to placebo. Further, the representative promoted the drug as a first-line therapy, rather than for its approved use in patients who have failed prior treatment, the agency charged.