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What Are Risks of Using a Drug for Something Other Than Intended Use?
Aired April 24, 2003 - 06:22 ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
CAROL COSTELLO, CNN ANCHOR: Turning now to matters of your health, a recent study reveals that a medication used to treat seizures is effective when principled for losing weight.
But what are the risks of using a drug for something other than its intended use?
Registered dietitian Lisa Drayer is director of nutrition services for Dietwatch.com Incorporated.
She joins us live from New York this morning.
Good morning, Lisa.
LISA DRAYER, NUTRITIONIST: Good morning, Carol.
COSTELLO: So tell us about these drugs.
DRAYER: Yes, actually, this particular study found that the medication Zonogran, which is used to treat epilepsy patients for seizures, was effect when it was principled for weight loss. The study found that women taking the drug lost about 13 pounds in a period of 16 weeks, whereas those who were on a placebo lost only about two pounds.
Now, previously it had been shown that those taking this drug for epilepsy had experienced unintentional weight loss and this is what prompted the study.
But this is what we call off label use, that is, when doctors prescribe a medication to treat a condition for which it has not yet received FDA review and approval. And it does carry some risks.
Now, this particular study didn't find any major risks. The most significant side effect was fatigue. But we don't necessarily know how different groups of people will respond to the same medication. And if we look in the past, we see examples where off label use did result in harm.
Do you remember the drug combination Fen-Phen?
COSTELLO: Oh, yes.
DRAYER: Many of, many individuals were taking that to lose weight but, in fact, the drugs were not intended to be used in combination and, in fact, at the higher dose and for a longer period of time. And so this is the reason that it most likely caused the heart valve damage and it is no longer available today.
COSTELLO: But other drugs with dual uses work quite well, like botox, right?
DRAYER: In fact, a lot of doctors will tell you that off label use, it's not their first line of therapy to treat a condition. But if other first line therapies have failed, then they will resort to other options and they will monitor carefully.
COSTELLO: So I can see people like going to their doctor and waiting this drug. Will the doctor prescribe it for someone who's obese to lose weight?
DRAYER: Some doctors have been prescribing it. Zonogran is one. Topamex is another example of a drug. But we really need to monitor patients carefully. That is, physicians should be looking at individuals and noting if they're good candidates for these types of medications. Not everyone is going to respond in the same way.
COSTELLO: So in talking about good candidates, there is a way to figure out if you are, indeed, obese. Tell us about that.
DRAYER: Yes, exactly. In order to be eligible for these medications, you want to have a body mass index of 30. That's considered obese. Body mass index you can figure out by simply taking your weight, multiplying that by 703 and then dividing that by your height squared. So if you would divide your weight by your height squared, that would give you your BMI.
Now...
COSTELLO: So give us an example to make it easier.
DRAYER: Sure. Sure. If you're 5'6" and you weigh 200 pounds, then you would have a BMI of 32. You'd be considered obese. Now, you are also intended for these drugs if your BMI is slightly lower, but you have existing risk factors for disease such as diabetes or high blood pressure.
COSTELLO: OK. And just so people, I know I didn't really catch the name of the drug, so tell us the name of the drug you're talking about this morning again.
DRAYER: Right. This particular drug is called Zonogran. And another drug that's being used to treat seizures and also sometimes being used off label for weight loss is Topamex.
But you do want to try diet and exercise first. If you haven't seen results in six months -- these are the clinical guidelines, an average of one pound per week for six months -- then it may be time to consider a weight loss medication. But be sure to speak with your doctor.
COSTELLO: Understand.
Lisa Drayer, many thanks. Helpful information, as always. DRAYER: Thank you.
TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com
Intended Use?>
Aired April 24, 2003 - 06:22 ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
CAROL COSTELLO, CNN ANCHOR: Turning now to matters of your health, a recent study reveals that a medication used to treat seizures is effective when principled for losing weight.
But what are the risks of using a drug for something other than its intended use?
Registered dietitian Lisa Drayer is director of nutrition services for Dietwatch.com Incorporated.
She joins us live from New York this morning.
Good morning, Lisa.
LISA DRAYER, NUTRITIONIST: Good morning, Carol.
COSTELLO: So tell us about these drugs.
DRAYER: Yes, actually, this particular study found that the medication Zonogran, which is used to treat epilepsy patients for seizures, was effect when it was principled for weight loss. The study found that women taking the drug lost about 13 pounds in a period of 16 weeks, whereas those who were on a placebo lost only about two pounds.
Now, previously it had been shown that those taking this drug for epilepsy had experienced unintentional weight loss and this is what prompted the study.
But this is what we call off label use, that is, when doctors prescribe a medication to treat a condition for which it has not yet received FDA review and approval. And it does carry some risks.
Now, this particular study didn't find any major risks. The most significant side effect was fatigue. But we don't necessarily know how different groups of people will respond to the same medication. And if we look in the past, we see examples where off label use did result in harm.
Do you remember the drug combination Fen-Phen?
COSTELLO: Oh, yes.
DRAYER: Many of, many individuals were taking that to lose weight but, in fact, the drugs were not intended to be used in combination and, in fact, at the higher dose and for a longer period of time. And so this is the reason that it most likely caused the heart valve damage and it is no longer available today.
COSTELLO: But other drugs with dual uses work quite well, like botox, right?
DRAYER: In fact, a lot of doctors will tell you that off label use, it's not their first line of therapy to treat a condition. But if other first line therapies have failed, then they will resort to other options and they will monitor carefully.
COSTELLO: So I can see people like going to their doctor and waiting this drug. Will the doctor prescribe it for someone who's obese to lose weight?
DRAYER: Some doctors have been prescribing it. Zonogran is one. Topamex is another example of a drug. But we really need to monitor patients carefully. That is, physicians should be looking at individuals and noting if they're good candidates for these types of medications. Not everyone is going to respond in the same way.
COSTELLO: So in talking about good candidates, there is a way to figure out if you are, indeed, obese. Tell us about that.
DRAYER: Yes, exactly. In order to be eligible for these medications, you want to have a body mass index of 30. That's considered obese. Body mass index you can figure out by simply taking your weight, multiplying that by 703 and then dividing that by your height squared. So if you would divide your weight by your height squared, that would give you your BMI.
Now...
COSTELLO: So give us an example to make it easier.
DRAYER: Sure. Sure. If you're 5'6" and you weigh 200 pounds, then you would have a BMI of 32. You'd be considered obese. Now, you are also intended for these drugs if your BMI is slightly lower, but you have existing risk factors for disease such as diabetes or high blood pressure.
COSTELLO: OK. And just so people, I know I didn't really catch the name of the drug, so tell us the name of the drug you're talking about this morning again.
DRAYER: Right. This particular drug is called Zonogran. And another drug that's being used to treat seizures and also sometimes being used off label for weight loss is Topamex.
But you do want to try diet and exercise first. If you haven't seen results in six months -- these are the clinical guidelines, an average of one pound per week for six months -- then it may be time to consider a weight loss medication. But be sure to speak with your doctor.
COSTELLO: Understand.
Lisa Drayer, many thanks. Helpful information, as always. DRAYER: Thank you.
TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com
Intended Use?>
