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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withdrawn from the market.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, with formatting and
highlights by SeniorJournal.com.
FDA Letter
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.
Sincerely,
Joan Hankin,
J.D.
Consumer
Promotion Analyst
Regulatory
Review Officer
Division of
Drug Marketing,
Advertising, and Communications
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