Are you ready for a new debate over off-label use of prescription drugs? A new study almost guarantees it. Going off-label with drugs may be perfectly legal, this report in Pharmacotherapy states, but those unapproved uses should at least be studied for safety and effectiveness. Without that research, off-label prescribing can easily be influenced by "opinion leaders" who sometimes are paid by drug companies to support unapproved uses, USA Today reports.
"Clearly, for many of these off-label uses, the manufacturers are benefiting enormously, and in some cases I think one could argue that off-label use has allowed them to circumvent the regulatory process," Randall Stafford, associate professor of medicine at the Stanford Prevention Research Center, told the newspaper. Although the regulatory process is not infallible, he says, "it does provide a level of scrutiny" beyond what the off-label uses have received.
The researchers identified 14 drugs whose off-label uses should be studied ASAP. Many of them are psychotropic drugs that are approved for one mental illness--such as depression--but often used for another. At the top of the list is AstraZeneca's Seroquel, approved for use in schizophrenia, but often prescribed as maintenance therapy for bipolar patients. And No. 3, Lexapro, is an approved antidepressant, but it's commonly used against bipolar disorder, too.
But psychiatric meds aren't the only ones in need of scrutiny, the researchers said. Ranking second on their list is Warfarin, approved to treat atrial fibrillation, but also prescribed to patients with hypertensive heart disease. And then there's Merck's Singulair, approved for asthma, but used also in chronic obstructive pulmonary disease. For the full 14-drug ranking, see the link below.
- check out the release
- read the USA Today story