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Off Label, Off Base?

Some doctors consider themselves innovators eager to try the newest drug, while others are desperate to find something that works for a patient who has exhausted all approved options. Off-label use is standard in the treatment of cancer and AIDS.

Misinformation also plays a role in off-label prescribing, Stafford said.

Many patients and some physicians, he said, think that if the FDA has approved a drug, it is safe and effective for multiple conditions, which is not the case. FDA approval is narrowly focused on a specific condition or ailment -- such as heart disease -- and for use in a specific population, such as adults or women. In other cases, Stafford said, doctors may not tell patients they are giving them an off-label drug.

Stafford and other experts suggest that if a medicine is being prescribed off-label, patients may want to ask their physician why -- especially if drugs approved for the condition have not been tried.

In some cases, said Schopick, doctors will resort to a novel off-label use to solve an intractable problem.

He cited his own recent experience treating a 16-year-old boy who developed a severe and disabling movement disorder caused by antipsychotic drugs. Schopick said he decided it might be worth using Aricept, an Alzheimer's drug, after reading a report about a similar case in which the drug was successful.

"Nothing else had worked, and I told him and his mother we could try the drug that I didn't think would harm him" but was unapproved, Schopick recalled.

They agreed, and it worked, he said.

Pediatricians often write off-label prescriptions because so few medicines have been approved for use in children or babies, noted Anne-Marie Irani, a pediatric allergist and professor at Virginia Commonwealth University.

"Unapproved does not mean contraindicated," she said. "This is something we discuss with our patients all the time."

Explaining the reason for an off-label prescription is particularly important for pediatricians, she said, because some parents will read a label, see that a drug has not been approved for babies and then not give it to their child.

Brian Strom, chief of biostatistics and epidemiology at the University of Pennsylvania School of Medicine, was the lead author of a 1985 study of off-label prescribing, the first to examine the issue.

In Strom's view, the most important issue is the quality of evidence on which such prescribing is based. The best example of the problem, he said, remains one of the most enduring: the use of antibiotics to treat colds. "It's completely contrary to labeling or appropriateness, and it's done all the time," Strom said.

Not only are antibiotics ineffective against viral infections, Strom said, they can be harmful, exposing the user to the risk of an allergic reaction and contributing to the problem of drug-resistant infections.

"In this society," Strom said, "I think rational use of drugs is very much a problem." ยท


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