Study Calls for Greater Scrutiny of 'Off-Label...(otic quetiapine (Seroquel) which is appr...),Health

Not only are their safety concerns about the drug, because of an FDA "black box" warning, but the drug costs $207 a prescription and has been marketed heavily, the study authors said. In 2004, the FDA had the drug manufacturer, AstraZeneca, add warnings about increased risks of hyperglycemia, high blood pressure and diabetes associated with use of the drug. Also, older patients with dementia-related psychosis treated with the drug are at an increased risk of death, according to the FDA.

The next four drugs on the list are the blood thinner warfarin, used off-label to treat hypertensive heart disease; the antidepressant escitalopram (Lexapro), used off-label to treat bipolar disorder; the schizophrenia drug risperidone (Risperdal), used off-label to treat bipolar disorder; and the asthma drug montelukast (Singulair), used off-label to treat chronic obstructive pulmonary disease.

Drug companies are usually prohibited from marketing their drugs for off-label use. But, they can share studies that support off-label use, the study authors said. A study published in 2006 found that of approximately 21 percent of off-label uses of drugs in 2001, 73 percent did not have adequate scientific support for the off-label use.

Still, Walton thinks off-label use should be allowed to continue, but the practice needs to be monitored. "There are certainly clinically sound reasons for some of the off-label use, but more effort should be made to follow-up on these uses," Walton said. "So allow them, but do a better job of tracking them and establishing the evidence."

Dr. David Flockhart, director of the Division of Clinical Pharmacology at Indiana University School of Medicine, thinks off-label use of drugs will become even more common, as researchers pursu
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