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In Depth: Investigating off-label uses of medications

In Depth: Investigating off-label uses of medications

Estimated read time: 2-3 minutes

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When a doctor prescribes drug treatment, that medication might not have been originally intended to treat the patient's condition. Now some medical officials say more research needs to go into this practice.

Imagine you have nerve pain. To deal with the pain, the doctor knows just what to give you.

Community Pharmacy Manager Gary Johnson said, "The drug Gabapentin has been very widely used for neuropathy, neuralgia [or] nerve pain."

Gabapentin was originally used as a seizure medication, but doctors noticed it worked so well on nerve pain they started prescribing it for its off-label use, instead of what it was originally approved for. Johnson says it's very common for doctors to prescribe drugs for a condition even if it's not approved by the FDA.

"In some of the books, the references you look up, you can find unlabeled uses for which it (the drug) has been used successfully," he said.

Johnson says most patients probably don't know about it, but, he says it's actually a beneficial practice.

"Many drugs are discovered that way, by discovering a drug they didn't intend to discover and found out that it, all of the sudden, was very effective for something they weren't even looking for," he explained.

But Newsday says some medical investigators want more research on off-label uses to determine how safe medications are for patients. Some doctors say, since the off-label uses aren't approved by the FDA, they understand why there would be a concern.

Utah Academy of Family Physicians President Jennifer Leiser said, "For me to say this is scientifically valid or I can statistically prove that this drug works for this group of people, I can't actually do that."

Leiser agrees that using prescriptions for off-label use isn't necessarily a bad thing, but if doctors rely too much on anecdotal evidence on what a drug can do and not scientific research, it could lead to problems.

"As always, the physician has the responsibility to understand the pros and cons of the use of the drug for any one patient and how likely it is to help them," she said.

Leiser says if the drug company wants to officially market the medicine for an off-label use, it has to be retested according to FDA standards, and that might not always happen.

"The drug company may or may not have a financial interest in promoting the drug for a different condition," she said.

She says putting a drug through FDA approved testing can take a lot of time and cost a lot of money.


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Paul Nelson


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