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FDA Orders Levitra Ad Pulled; Seniors Should Read Objections
April 16, 2005 – The FDA yesterday notified the makers of Levitra (vardenafil
HCI) their television ads for the erectile dysfunction drug must be withdrawn
from the market. The regulators called the ads “misleading” and say they fail to
disclose “major side effects.” This and other erectile dysfunction drugs are
widely used by senior citizens, who should pay careful attention to the message
from the FDA.
 Here are some of the highlights from the letter sent by Joan Hankin, an attorney
in the FDA’s Division of Drug Marketing, to Bayer Pharmaceuticals, the drug
maker, and copied to the marketing companies Schering and GlaxoSmithKline.
In referring to the ad, she notes these failures:
> 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
> 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.
She particularly raises questions about implications in the commercial that
Levitra will provide a satisfying sexual experience from the female partner's
perspective
The text of the letter follows.
This letter notifies Bayer Pharmaceuticals Corporation (Bayer) and, by copy,
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) submitted
under cover of Form FDA 2253 (entitled “My Man” ID# LEV680R0/PD3816504).
The TV 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), 21 U.S.C. § 352(n), and FDA
implementing regulations, 21 CFR §§ 202.1(e)(1) and (e)(3). Moreover, 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. See 21
CFR § 202.1(e)(6)(ii).
Background
According to FDA-approved labeling (PI), “LEVITRA is indicated for the treatment
of erectile dysfunction” (ED). The Contraindications section of the PI states,
in part: Administration of LEVITRA with nitrates (either regularly and/or
intermittently) and nitric oxide donors is contraindicated (see CLINICAL
PHARMACOLOGY, Pharmacodynamics, Effects on Blood Pressure and Heart Rate when
LEVITRA is Combined with Nitrates). Consistent with the effects of PDE5
inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5
inhibitors may potentiate the hypotensive effects of nitrates. A suitable time
interval following LEVITRA dosing for the safe administration of nitrates or
nitric oxide donors has not been determined.
Because the co-administration of alpha-blockers and LEVITRA can produce
hypotension, LEVITRA is contraindicated in patients taking alpha-blockers (see
PRECAUTIONS, Drug Interactions).
The Warnings section of the PI states, in part: Physicians should consider the
cardiovascular status of the patients, since there is a degree of cardiac risk
associated with sexual activity. In men for whom sexual activity is not
recommended because of their underlying cardiovascular status, any treatment for
erectile dysfunction, including LEVITRA, generally should not be used.
There have been rare reports of prolonged erections greater than 4 hours and
priapism (painful erections greater than 6 hours in duration) for this class of
compounds, including vardenafil. In the event that an erection persists longer
than 4 hours, the patient should seek immediate medical assistance. If priapism
is not treated immediately, penile tissue damage and permanent loss of potency
may result.
Additionally, the Precautions section of the PI includes the statement, “The use
of LEVITRA offers no protection against sexually transmitted diseases.”
According to the Adverse Reactions section of the PI, adverse events associated
with Levitra include headache, flushing, rhinitis, dyspepsia, and nausea.
Omission of Indication and Risk Information
"Reminder advertisements are those which call attention to the name of the drug
product but do not include indications or dosage recommendations for use of the
drug product." In addition, "[t]hese reminder advertisements shall contain . . .
no representation or suggestion relating to the advertised drug product." See 21
CFR 202.1(e)(2)(i).
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 sexual 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. She states (corresponding visuals in parentheses):
(Match striking and igniting)
“In the mood for something different?”
“How about Levitra?”
“Ask your doctor if Levitra is right for you.”
“It’s the best way to experience that difference.”
“Ask about a free sample. Ask about Levitra. Levitra. When it counts.”
(Match striking and igniting, with simultaneous SUPERs including: “LEVITRA –
When It Counts -- “Individual results may vary”)
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 sexual 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 (i.e., it may work to improve sexual
activity in some, but not all men with ED).
Because the ad is not a reminder ad, it must present the indication and
information relating to the major side effects and contraindications, and must
make adequate provision for dissemination of the FDAapproved labeling. See 21
CFR 202.1(e)(1) and (e)(3). The TV ad fails to include the specific indication
for the drug (namely, treatment of erectile dysfunction) or the required risk
information.
The TV ad also fails to make adequate provision for dissemination of the
FDA-approved labeling.
Implied Superiority
As described above, the woman in the ad asks “In the mood for something
different? How about Levitra?”
She then adds, “Ask your doctor if Levitra is right for you. It’s the best way
to experience that difference.” These claims suggest that Levitra is superior to
other treatments for ED.
FDA is not aware of substantial evidence or substantial clinical experience
demonstrating that Levitra is superior to other ED treatments. If you have data
substantiating this claim, please submit them to FDA for review.
Conclusion and Requested Actions
For the reasons discussed above, your TV ad misbrands Levitra under section
502(n) of the Act, 21 U.S.C. § 352(n), and FDA implementing regulations, 21 CFR
§§ 202.1(e)(1), (e)(3) & (e)(6)(ii).
DDMAC requests that Bayer immediately cease the dissemination of promotional
materials for Levitra the same as or similar to those described above.
Please submit a written response to this letter on or before April 27, 2005
describing your intent to comply with this request, listing all promotional
materials for Levitra the same as or similar to those described above, and
explaining your plan for discontinuing use of such materials. Please direct your
response to me at the Food and Drug Administration, Division of Drug Marketing,
Advertising, and Communications, HFD-42, Rm. 8B-45, 5600 Fishers Lane,
Rockville, Maryland 20857, facsimile at (301) 594-6771. In all future
correspondence regarding this matter, please refer to MACMIS ID # 13014 in
addition to the NDA number. We remind you that only written communications are
considered official. The violations discussed in this letter do not necessarily
constitute an exhaustive list. It is your responsibility to ensure that your
promotional materials for Levitra comply with each applicable requirement of the
Act and FDA implementing regulations.
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