No Levitra recall despite misleading ads
Levitra, the drug that competes with Viagra, is in trouble, though there is no indication that it is in the kind of trouble like Vioxx, Celebrex, and Bextra are. In other words, no talk of a "Levitra recall" yet since that is the last word any drugmaker CEO wants to hear these days. The US Food & Drug Administration (FDA) is asking Bayer Pharmaceuticals Corporation (Bayer). Schering Corporation (Schering) and GlaxoSmithKline (GSK), which market Levitra on behalf of Bayer, that the Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed a direct-to-consumer television advertisement (TV ad) for Levitra (vardenafil HCl) Tablets (Levitra) entitled "My Man" and found that the ad fails to disclose the drug's indication, fails to include information relating to the major side effects and contraindications, and fails to make adequate provision for dissemination of the FDA-approved labeling in violation of the Federal Food, Drug and Cosmetic Act (Act).
In a letter sent to the drugmakers, the FDA's Joan Hankin charges that the TV ad is misleading because it contains representations or suggestions that Levitra is superior to other erectile dysfunction treatments when this has not been demonstrated by substantial evidence or substantial clinical experience.
In the opinion of the FDA, the TV ad makes representations or suggestions that Levitra has a positive effect on the relationship between two intimate individuals, and that Levitra will provide a satisfying personal experience from the female partner's perspective. For example, the partner of the Levitra patient speaks to the camera while the video flashes-back to moments when she and her "man" appear romantically involved.
Another scene shows a smiling man and two other quick scenes depict the couple engaged in flirtatious behavior. In one of these scenes, the man strokes the woman's hair and face as she affectionately puts her hand on his wrist. In the other, she puts her arms around his neck and they embrace. The totality of the TV ad also represents or suggests that Levitra will provide a satisfying experience from the female partner's perspective. For example, the visual images in the ad show the female partner of the Levitra patient in moments where she appears to be romantically involved with the Levitra patient and the audio portion contains claims from the female partner about how Levitra is the "best way to experience the difference."
The fact that effectiveness claims are being made about Levitra in the TV ad is acknowledged by the sponsor by the inclusion of a qualifier to the claim "Levitra. When it counts" a concurrent SUPER that states: "Individual results may vary." This disclosure about varying "results" recognizes that the ad makes representations about the drug's efficacy.
DDMAC has directed that Bayer immediately cease the dissemination of promotional materials for Levitra the same as or similar to those described above.
Related article
Viagra recall
In a letter sent to the drugmakers, the FDA's Joan Hankin charges that the TV ad is misleading because it contains representations or suggestions that Levitra is superior to other erectile dysfunction treatments when this has not been demonstrated by substantial evidence or substantial clinical experience.
In the opinion of the FDA, the TV ad makes representations or suggestions that Levitra has a positive effect on the relationship between two intimate individuals, and that Levitra will provide a satisfying personal experience from the female partner's perspective. For example, the partner of the Levitra patient speaks to the camera while the video flashes-back to moments when she and her "man" appear romantically involved.
Another scene shows a smiling man and two other quick scenes depict the couple engaged in flirtatious behavior. In one of these scenes, the man strokes the woman's hair and face as she affectionately puts her hand on his wrist. In the other, she puts her arms around his neck and they embrace. The totality of the TV ad also represents or suggests that Levitra will provide a satisfying experience from the female partner's perspective. For example, the visual images in the ad show the female partner of the Levitra patient in moments where she appears to be romantically involved with the Levitra patient and the audio portion contains claims from the female partner about how Levitra is the "best way to experience the difference."
The fact that effectiveness claims are being made about Levitra in the TV ad is acknowledged by the sponsor by the inclusion of a qualifier to the claim "Levitra. When it counts" a concurrent SUPER that states: "Individual results may vary." This disclosure about varying "results" recognizes that the ad makes representations about the drug's efficacy.
DDMAC has directed that Bayer immediately cease the dissemination of promotional materials for Levitra the same as or similar to those described above.
Related article
Viagra recall
posted by eCreativa Media | 7:58 PM 
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