14 drugs identified in USA as most urgently needing study for off-label use

Physicians and policy-makers know that drugs are frequently prescribed to treat certain diseases, despite a lack of US Food and Drug Administration approval - a practice known as off-label prescribing. Yet they say the problem is so big they do not know how to begin tackling it. But a potential game plan now exists. In a paper published in the December issue of Pharmacotherapy, a group of researchers has developed a list of 14 widely prescribed medications most urgently in need of additional study to determine how effective and safe they are for their off-label uses. Antidepressants and antipsychotics are the most prominent classes of drugs on the list, which specifically targets drugs that have high levels of off-label use without good scientific backing. "Off-label prescribing means that we're venturing into uncharted territory where we lack the usual level of evidence presented to the FDA that tells us these drugs are safe and effective," stated Randall Stafford, associate professor of medicine at the Stanford Prevention Research Center, USA, the senior author of the study. "This list of priority drugs might be a start for confronting the problem of off-label use with limited evidence." Dr Stafford collaborated on the research with lead author Surrey Walton, assistant professor of pharmacy administration at the University of Illinois-Chicago, as well as other researchers at the UIC and the University of Chicago.

Quetiapine tops the listing

At the top of the list was quetiapine (brand name Seroquel), an antipsychotic approved by the FDA in 1997 for treating schizophrenia. Not only did this lead all others in its high rate of off-label uses with limited evidence (76% of all uses of the drug), it also had features that raised additional concerns, including its high cost at $207 per prescription, heavy marketing and the presence of a "black-box" warning from the FDA, Dr Stafford said.