The US Food and Drug Administration has issued a warning to giant Pfizer that a journal advertisement for its antibiotic Zyvox (linezolid) contravened regulations by implying superiority to another compound, vancomycin, broadening the indication and failing to reveal important risk information. This, says the agency, “poses serious public health and safety concerns because of its potential to result in the inappropriate use of Zyvox, which is associated with increased toxicity relative to vancomycin.”

The company has been requested to put a stop on the promotional materials in question and to submit a written response to the agency before August 3 outlining whether it plans to comply and how it will “disseminate truthful, non-misleading, and complete corrective messages…to the audience that received the violative promotional materials.”

- Meanwhile, Actelion has also received an agency warning that a product page for its pulmonary hypertension drug Tracleer (bosentan) is “false and misleading” because it omits risk information, overstates the drug’s efficacy and contains claims that broadens its indication. It has also been tasked with providing an action plan as to how it will disseminate truthful materials to its audience.