GlaxoSmithKline warned over Avandia promotion by US FDA

GlaxoSmithKline has been sent a warning letter from the US Food and DrugAdminstration charging that the company's sales representatives were seen to be denying the existence of serious new risks associated with its diabetes drug, Avandia (rosiglitazone), at the recent American Association of Clinical Endocrinologists in San Antonio, USA.

The FDA has cited GSK on a number of occasions over improper promotion of Avandia, the most recent being at the end of last year when the agency claimed that materials being used to push the drug minimized the precautions for its use by those with liver damage (Marketletter November 6, 2000). The warning letter, sent July 17, says that the firm "has continued to engage in false or misleading promotion of Avandia" despite these earlier notices.

GSK spokeswoman Karen Collins told Reuters that company officials "have responded [to the letter] and we are awaiting further discussion with the agency," adding that "we're working closely with them to address their issues.''