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American Morning

New Antidepressant Approved by FDA

Aired August 16, 2002 - 08:37   ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.

BILL HEMMER, CNN ANCHOR: Medical news this morning now. The leading seller of the popular but somewhat controversial weight loss supplement ephedra under a criminal investigation now by the Justice Department. The FDA has received unsubstantiated reports that link the diet supplement to at least 70 deaths in recent years.
No matter, millions of people hoping to lose weight still use it, and Dr. Sanjay Gupta more this morning on what gives here in our "House Call" -- good morning to you.

DR. SANJAY GUPTA, CNN MEDICAL CORRESPONDENT: Good morning.

HEMMER: Ephedra, the issue is what then?

GUPTA: Metabolife International, the leading seller, the largest manufacturer of this particular dietary supplement is at the center of this maelstrom, no question about it.

At issue, 13,000 calls that were received between '97 and 2002 about health related adverse effects. The calls were voluntary calls placed directly to the company. When then president Michael Ellis (ph) was asked about that in 1998, he said they hadn't received any.

So that's really what the Justice Department is looking into now. Also at issue -- part of the reason this is such a big deal is because this is a very, very popular dietary supplement. Twelve million people took it in 1999. The dietary supplement industry is a $14 billion -- with a "b" -- industry. And the industry has been largely unregulated. These are dietary supplements. The FDA has really kept a hands-off approach for the most part. It may change with this.

HEMMER: Ephedra, you're on it, you use it. How does it work? What is the effect?

GUPTA: This is an herb, and that's part of the reason that it's actually classified as a dietary supplement. You don't need a prescription for this. It's also called ma huang. That is the ancient Chinese name for it. A lot of people know it as that still.

Basically what it is, it's both a brain and a body stimulant, raises your blood pressure, raises your heart rate, things like that. And it can also cause all sorts of different adverse effects. Some of them we can put up on the screen here. You can actually take look at what the supplement can do in addition to making you lose weight. I don't know if we have the list there, but certainly all those thins you see there, finishing off with headaches. None of those things particularly life threatening, but if you look at some of the other adverse effects, it can actually raise your blood pressure, can cause heart attacks, seizures, strokes, possibly even death.

Bill, 70 deaths have been linked to this, and link is a very, very sort of tough word in the epidemiological world that means that they were taking it. They all died. It's hard to say that it actually caused that. is also going to be the subject of the investigation.

HEMMER: There could have been many more factors involved there, especially with a pool of 70 people.

Listen, there's a new antidepressant drug, apparently now it has been approved, out first part of September, which brings the number to six, half a dozen right now.

GUPTA: That's right. Six in this one class of drugs alone known as selective seratonin inhibitors. The name is not that important, but you know these drugs as Prozac, Luvox, Zoloft. This drug, Lexapro, the new drug, it is going to be out in September, is most similar to Celexa.

Many ask, why do you need another one? You have already got five. But this medication has a couple of things, at least the manufacturers are touting. One is that it is more potent, it is more powerful. Actually also quicker acting, actually gets into the system more quickly, and finally, perhaps most importantly, has fewer side effects. Side effects have been a big problem with antidepressants, 10 percent in some of these older drugs, perhaps only 5 percent in this particular medication.

HEMMER: I was surprised to hear that -- 18 million Americans is the figure that use some sort of antidepressant drug, of the ones we mentioned. Ten percent have quit because of the side effects, being what?

GUPTA: Side effects can be all sorts of stuff from GI upset to nervousness, restlessness, can even cause some problems with blood pressure sometimes. Seratonin, the chemical that this particular medication is targeting, is a chemical that's in the brain, and it can have all sorts of different effects.

Luckily, the medications have become much better over time, and this is going to be just another one that physicians have in their -- there are people, Bill, that have gone through all five of them, and have had no benefit from any of them, so this is going to be yet another option.

HEMMER: And you say it could be more powerful, most similar to Celexa, and that's the reason why this one could be effective for others.

GUPTA: That's right. And, you know, it is sort of interesting as well. We won't know for sure. You know, they have done these studies on this particular medication -- you and I have talked about this. Until you actually release this medication into the general public, it's going to be hard to know, A, how powerful is it really to the general public, and B, are those side effects really only at 5 percent, or when you release it to the general public, do you find side effects that you otherwise wouldn't have found? Need that larger pool of people.

HEMMER: Interesting stuff, and you're the man who knows. Thank you, Doctor.

GUPTA: Good to see you, Bill.

HEMMER: Have a good weekend.

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