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FDA Warns Makers of Levitra, Zyrtec Over Advertisements
ap.tbo.com ^ | Apr 15, 2005 | Juan-Carlos Rodriguez

Posted on 04/15/2005 7:59:03 PM PDT by foolscap

WASHINGTON (AP) - Federal regulators have told the makers of the popular drugs Levitra and Zyrtec to pull some advertisements the regulators said made unsubstantiated claims. The Food and Drug Administration said Friday it sent letters this week notifying Bayer Pharmaceuticals Corp. and Pfizer Inc. that a television commercial for Levitra and three direct-mail advertisements for Zyrtec made unsubstantiated claims of superiority over competing products.

In Levitra's case, Bayer also failed to disclose FDA warnings and product information, the letter said. It was the fourth such warning for Pfizer about Zyrtec.

The commercial for Levitra, an erectile dysfunction drug, features a woman praising the drug, and, according to the FDA, implying that her sexual experience with her partner was satisfying as a result of her partner's use of Levitra. She says the drug is "the best way to experience the difference." The FDA said this is an unprovable claim.

The commercial also fails to highlight side effects and FDA warnings, the agency said.

Matthew Scampoli, a spokesman for Schering Corp., which markets Levitra for Bayer, said the 15-second commercial is one in a three-commercial campaign. He said the remaining commercials would remain on the air but said, "We are going to comply with the FDA's request," to pull the 15-second spot.

"We're currently reviewing all our Levitra promotional material to address the issues raised by the agency," he added.

The ads for Zyrtec compare two people; one obviously sick, sneezing or wiping her nose, and another who looks perfectly healthy. The captions of the ads imply that the healthy and alert-looking person has taken Zyrtec; the sickly and unhappy one has taken a different medication.

The FDA said it "is not aware of substantial evidence or substantial clinical experience demonstrating that Zyrtec is clinically superior" to any other available over-the-counter or prescription allergy medicine.

An attempt to reach Pfizer by telephone after business hours on Friday was unsuccessful.

The FDA requested that both companies cease the ad campaigns and respond in writing to the request. It also said that since this was the fourth warning about the same problem for Pfizer, that Pfizer include in its response an outline of how it plans to make "truthful, non-misleading and complete" corrections to its ads


TOPICS: Extended News; News/Current Events
KEYWORDS: ads; fda; health; healthcare; levitra; zyrtec
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1 posted on 04/15/2005 7:59:03 PM PDT by foolscap
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To: foolscap
The commercial for Levitra, an erectile dysfunction drug, features a woman praising the drug, and, according to the FDA, implying that her sexual experience with her partner was satisfying as a result of her partner's use of Levitra. She says the drug is "the best way to experience the difference." The FDA said this is an unprovable claim.

Okay, okay. But the possibility of getting a 4 hour erection is true, right?

2 posted on 04/15/2005 8:02:06 PM PDT by Texas Eagle (If it wasn't for double-standards, Liberals would have no standards at all)
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To: Texas Eagle

Okay, okay. But the possibility of getting a 4 hour erection is true, right?




Yes, they tell you to call your doctor if it lasts longer than 4 hours.


3 posted on 04/15/2005 8:04:14 PM PDT by hipaatwo
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To: foolscap
You mean its not strong, not lasting, and not when he wants it?
4 posted on 04/15/2005 8:06:20 PM PDT by Pukin Dog (Sans Reproache)
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To: hipaatwo
Yes, they tell you to call your doctor if it lasts longer than 4 hours.

What good would that do? I couldn't get an appointment for 3 weeks.

5 posted on 04/15/2005 8:07:38 PM PDT by Texas Eagle (If it wasn't for double-standards, Liberals would have no standards at all)
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To: Texas Eagle

LOL trust me, as I woman I wouldn't complain.


6 posted on 04/15/2005 8:12:57 PM PDT by hipaatwo
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To: foolscap

The Levitra advertisement says if your erection lasts longer than four hours, go to a hospital. What for - to have your picture taken?


7 posted on 04/15/2005 8:13:02 PM PDT by mohresearcher
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To: foolscap
What now? Phase IV randomized trials comprised of women "experiencing" men on Levitra versus men without Levitra (the placebo?).
8 posted on 04/15/2005 8:13:28 PM PDT by Iwo Jima
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To: hipaatwo

Exactly. I mean, why go see a doctor? So he can prescribe something to counteract it? Doesn't that defeat the purpose for taking it in the first place?


9 posted on 04/15/2005 8:14:25 PM PDT by Texas Eagle (If it wasn't for double-standards, Liberals would have no standards at all)
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To: Texas Eagle

Well, lets put it this way, blood would only be flowing one way and what good is it if your passed out and can't enjoy it.


10 posted on 04/15/2005 8:16:34 PM PDT by hipaatwo
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To: hipaatwo
LOL trust me, as I woman I wouldn't complain.

Neither would my wife. For once she wouldn't give a damn that I fell asleep afterwards.

Talk about a win-win situation.

11 posted on 04/15/2005 8:16:59 PM PDT by Texas Eagle (If it wasn't for double-standards, Liberals would have no standards at all)
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To: Texas Eagle

ROFLAMO!!!!!!!!!!!!


12 posted on 04/15/2005 8:18:09 PM PDT by hipaatwo
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To: hipaatwo
Well, lets put it this way, blood would only be flowing one way and what good is it if your passed out and can't enjoy it.

How ironic. My reply to your post #6 also applies to your post #10.

13 posted on 04/15/2005 8:18:39 PM PDT by Texas Eagle (If it wasn't for double-standards, Liberals would have no standards at all)
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To: Texas Eagle
What good would that do? I couldn't get an appointment for 3 weeks.

Well, if you still need to see the doc after three fun-filled weeks, he wouldn't have to just take your word for it, would he?

14 posted on 04/15/2005 8:19:32 PM PDT by Hank Rearden (Never allow anyone who could only get a government job attempt to tell you how to run your life.)
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To: Iwo Jima

What now? Phase IV randomized trials comprised of women "experiencing" men on Levitra versus men without Levitra (the placebo?).



Not a bad idea :)


15 posted on 04/15/2005 8:19:54 PM PDT by hipaatwo
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To: Hank Rearden

Wow. 3 weeks. Just how much does a Guiness World Record pay these days?


16 posted on 04/15/2005 8:20:58 PM PDT by Texas Eagle (If it wasn't for double-standards, Liberals would have no standards at all)
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To: Texas Eagle

I can't tell you how hard (bad choice of words) and loud I'm laughing right now.


17 posted on 04/15/2005 8:21:17 PM PDT by hipaatwo
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To: Iwo Jima
What now? Phase IV randomized trials comprised of women "experiencing" men on Levitra versus men without Levitra (the placebo?).

Turns out, all my relationships have just been placebos.

18 posted on 04/15/2005 8:21:31 PM PDT by Hank Rearden (Never allow anyone who could only get a government job attempt to tell you how to run your life.)
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To: Texas Eagle
Exactly. I mean, why go see a doctor? So he can prescribe something to counteract it? Doesn't that defeat the purpose for taking it in the first place?

In all seriousness (well, as serious as we're going to be able to get on this thread), a 4-hour erection is a sign of priapism, which is nothing to joke about. If you don't get medical treatment for it within a few hours, you could end up never having another erection again.

(To get technical, the blood get stuck in there, loses its oxygen, and you end up with the same problems you'd have with any other body part that had its circulation cut off.)

Supposedly it also hurts like hell, too, so you'd probably be hightailing it to the ER regardless. ;)

19 posted on 04/15/2005 8:21:39 PM PDT by Dont Mention the War (Proud Member of the WPPFF Death Cult - We're coming after YOU next!)
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To: Texas Eagle
Wow. 3 weeks. Just how much does a Guiness World Record pay these days?

Same as a mohel. Minimum wage, plus tips.

20 posted on 04/15/2005 8:22:42 PM PDT by Hank Rearden (Never allow anyone who could only get a government job attempt to tell you how to run your life.)
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