I wonder, can you see a pattern forming here?
This time it’s not Seroxat but Avandia – read on from the Chicago Tribune:
GlaxoSmithKline PLC, Europe’s largest drugmaker, failed to properly disclose studies of Avandia, the diabetes pill linked to potentially deadly side effects, U.S. regulators said.
The violations “are serious and may be symptomatic of underlying post-marketing safety reporting failures,” the Food and Drug Administration said in a letter posted on its Web site. The agency said it was never told about nine studies, and an additional 11 weren’t included in required annual reports from 2001 to 2007.
Avandia sales plunged last year after a May 21 report in the New England Journal of Medicine linked the drug to a 43 percent increased risk of heart attacks, prompting U.S. and European regulators to strengthen warnings on its prescribing information. The FDA found unreported research while inspecting paperwork at London-based Glaxo’s offices in Research Triangle Park, N.C., from August to November, according to the letter.
Meanwhile, Glaxo said 247 lawsuits have been filed in the U.S. over Avandia.
And just one other thing – I thought’d read somewhere that Glaxo proudly boasts it places all clinical trial data on the internet… well, almost all it seems.