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(Ivanhoe Newswire) -- A panel of government and health-industry experts has developed a list of 14 widely prescribed medications they say urgently need additional study to determine how safe and effective they are for off-label uses.
Once a drug is approved by the FDA to treat one certain illness or condition, physicians may choose to prescribe it for any condition, a practice known as off-label prescribing. However, this practice carries unknown risks because often the drug has not been rigorously tested on patients with that condition.
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Some studies have shown that as much as 31 percent of common prescriptions for drugs lack FDA approval.
For this study, lead author Randall Stafford, M.D., Ph.D., an associate professor of medicine at the Stanford Prevention Research Center, convened a panel of nine experts from the FDA, the health-insurance industry, the pharmaceutical industry and academia to determine which drugs were most in need of additional research for off-label use.
Topping the list was quetiapine, which is marketed under the brand name Seroquel, an antipsychotic drug approved by the FDA in 1997 for treating schizophrenia. The researchers found that not only does this drug lead all others in its high rate of off-label use with limited evidence (76 percent of all uses of the drug), it also carries a high cost at $207 per prescription, it is heavily marketed and it has a black-box warning from the government.
Antidepressants and antipsychotics are the most common classes of drugs on the list. Rounding out the top five are: warfarin, escitalopram, risperidone and montelukast. Researchers said the most common off-label use for six of the 14 drugs was for bipolar disorder.
Stafford said he hopes his research spurs patients to ask their doctors why they are prescribing a particular drug.
A dialogue needs to occur more frequently between physicians and patients regarding the level of evidence that supports a particular use of a drug, Stafford was quoted as saying.
He said once a drug is approved by the FDA, drug companies often arent interested in spending more money to investigate additional conditions the drugs might treat because further testing could show undesired results, especially when the drug is already widely used off-label.
SOURCE: Pharmacotherapy, December 2008
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