Just over half of the respondents to a MedPage Today poll think the FDA spoke too soon when it revealed -- then quelled -- concerns about the cardiovascular safety of proton-pump inhibitors. But the rest welcomed the information.
Fifty-three percent of the 905 respondents to a MedPage Today poll think the FDA spoke too soon when it revealed -- then quelled -- concerns about the cardiovascular safety of two proton-pump inhibitors.
They feared that worried patients taking omeprazole (Prilosec) or esomeprazole (Nexium) would have many questions about whether to continue on them.
But the rest of the respondents welcomed the information, saying they want to know about issues like this as soon as possible.
The FDA announced on Aug. 9 that studies of the two prescription proton-pump inhibitors had raised concerns about their cardiovascular safety.
Yet the agency added that its preliminary assessment was that the problems seen in those studies were "not a true effect," while a final safety report remained three months away.
Although it was clear that the agency was reacting to criticism that it withheld data on the cardiovascular safety of rosiglitazone (Avandia), the timing of the proton-pump inhibitor announcement raised questions.
Why not make the announcement in late May, when the concerns were first raised? Why issue a limited "all clear" in August, but note that final word may not be available until November?
To see whether physicians considered a strategy like this to be constructive or counterproductive, MedPage Today asked in its survey whether the FDA should have waited for more definitive data before making the issue public.