‘Off-label’ medications can bring mixed results

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'Off-label' medications can bring mixed resultsBy Shari Roan | Los Angeles

Times |

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Millions of Americans each year are prescribed drugs that are not approved

for their specific medical condition, a practice known as " off-label " use,

that is legal and logical in many cases.

But a new study has found that 20 percent of all prescriptions are written

for non-approved off-label uses and that most of these uses — three-quarters

— are not well-supported by scientific research.

This widespread use of medications off-label could threaten patients' safety

while escaping the attention of federal regulators, some experts suggest.

" What surprised me about this study is that in many cases there is a paucity

of scientific studies supporting the drug's use off-label, " says I.

Kaitin, director of the Tufts Center for the Study of Drug Development.

" It's an issue that should be discussed in the medical community. "

Still, Kaitin says, it's unclear whether consumers are being put at undue

risk. " There has not been a significant problem with off-label prescribing

that I'm aware of, " he says.

The study, published last week in the Archives of Internal Medicine, polled

3,500 randomly selected doctors on their patient interactions over two

consecutive days in 2001, including any drugs they may have prescribed.

Researchers then retrieved information on the 100 most commonly prescribed

drugs as well as 60 more drugs also randomly selected.

Among other things, the scientists found that cardiac medications,

anticonvulsants and asthma medications were the most likely to be prescribed

off-label. Psychiatric drugs and allergy medications were the most likely

types of drugs to be used off-label with little scientific support. In fact,

scientific support was lacking for 96 percent of the psychiatric drugs

prescribed off-label.

Dr. Randall S. Stafford, lead author of the study and an associate professor

of medicine at the Stanford Prevention Research Center, said the findings

were troubling. Even though drugs are thoroughly reviewed by the Food and

Drug Administration before they're allowed to go to market, " the FDA does

not vouch for the safety and efficacy of all the various ways that drugs are

used, " he says.

Drugs, he adds, are tested and approved at specific doses with detailed

information about side effects that occurred during the trials — but those

data may be irrelevant when a medication is used for a different diagnosis

and in different types of patients.

Off-label use of drugs is not rare. Once a drug reaches the market, doctors

can legally prescribe it for any diagnosis. This long-standing practice has

been lauded for allowing doctors the freedom to treat their patients based

on the latest scientific studies and clinical information.

In certain areas of medicine, such as pediatrics, off-label use of

medications is almost unavoidable because, until recently, drug

manufacturers were not required to conduct research on how their products

affect children. And in cancer treatment, off-label use allows doctors to

try different strategies for seriously ill patients who have exhausted other

options.

Off-label use also makes sense when the drug is prescribed for a condition

very similar to its approved indication. For example, Stafford says, doctors

can reasonably assume that a drug used to treat asthma will be effective for

other lung diseases.

" There are plenty of situations where off-label use is completely

legitimate, " says Stafford, " But there are other ways that drugs are used

that are quite distinct from the FDA indication and where we don't have good

information. "

For example, he says, the Type 2 diabetes drug metformin is frequently

prescribed for women with polycystic ovary syndrome. Gabapentin, a seizure

drug, is widely prescribed for chronic pain. At the time the study was

undertaken, in 2001, there was some preliminary evidence that those drugs

had other beneficial uses, but it was not substantial.

However, safety issues are more likely to come to the attention of health

regulators regarding an FDA-approved use of a drug than a non-approved use,

Stafford says.

The study did not address why doctors prescribe so many off-label

medications bearing little scientific support. It is illegal for drug

company sales representatives to promote off-label uses, although some

experts think that practice occurs. (Pfizer, manufacturer of the gabapentin

drug Neurontin, was convicted in 2004 for inappropriate marketing of

off-label uses.)

Doctors often learn about novel drug uses from colleagues or from

preliminary studies. The desire to offer patients the latest therapies may

lead them to make a leap of faith with an off-label drug, Stafford says.

Consumers should ask if the prescription they receive is approved for their

condition or has been adequately studied, he says. Doctors " need to think

about the degree of evidence that supports what we do. "