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Doctors confused about FDA approval

A survey of 1,199 doctors and psychiatrists across the US indicates many are confused about the FDA approval status of drugs

A recent survey of 1,199 doctors and psychiatrists across the US, indicates that many are confused about the Food and Drug Administration (FDA) approval status of drugs. In all, the study group correctly identified just over half of the drug and indication pairings (mean 55 per cent) presented to them. 

The research results, published in Pharmacoepidemiology and Drug Safety, also showed that about a quarter of the respondents (26 per cent) erroneously believe that lorazepam (originally branded as Ativan and Temesta) is FDA approved for chronic anxiety. A third of the doctors who had actually prescribed the drug also believed this to be so.

A small but significant group –13 per cent of those doctors who responded – believe that Seroquel (quetiapine) is approved by the FDA for the treatment of dementia with agitation. Of those doctors who had prescribed it in this patient group, 19 per cent were not aware that this is off-label use. 

The FDA sets out criteria on the product label – such as indication, dose, intended patient population and treatment duration – that marketers of the drug must adhere to. Doctors, however, are free to prescribe drugs for any indication.

One of the paper's authors, Dr Donna Chen, assistant professor of Biomedical Ethics, Public Health Sciences and Psychiatry at the University of Virginia, said although many doctors feel that prescribing decisions should be led by clinical evidence rather than the label, "FDA approval of a drug for a specific indication indicates a clear threshold of evidence supporting that use". 

Dr G Caleb Alexander, from the University of Chicago Medical Center, who was also involved in the study, said: "Our research shows that some off-label prescribing might be driven by mistaken beliefs about FDA approval and the level of evidence supporting off-label drug use."

The highest rates of off-label use were for anticonvulsants (74 per cents), antipsychotics (60 per cent) and antibiotics (41 per cent).

25th August 2009

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