FDA warns GlaxoSmithKline, Novartis and Astellas over drug promotions

The FDA posted on its website letters to GlaxoSmithKline, Novartis and Astellas claiming that the drugmakers improperly promoted some of their products.

The agency said that a medical journal advertisement for GlaxoSmithKline's chronic lymphocytic leukaemia treatment Arzerra (ofatumumab) "omits important information" related to the drug's safety and effectiveness. In a separate letter, regulators cited the UK drugmaker and Astellas for providing unsubstantiated superiority claims and exaggerating the effectiveness of its co-marketed overactive bladder treatment, Vesicare (solifenacin) on a promotional webpage.

Finally, the agency issued a letter to Novartis stating that an email sent to consumers "minimises risks associated with the use of Voltaren Gel (diclofenac), overstates the efficacy of Voltaren Gel and broadens the indication for Voltaren Gel."

Noting that "we take the FDA's concerns seriously," GlaxoSmithKline spokeswoman Mary Anne Rhyne said the company removed the content in question from the Vesicare website and will cease use of the Arzerra advertisement. She added that the company is "working to resolve any remaining questions and ensure our materials reflect the direction provided by the FDA." A Novartis spokeswoman, meanwhile, said the company was reviewing the agency's letter and would work with regulators to address concerns.

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