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  FDA Warning Letter  

Link:  Pharm/Biotech Resources
 

Posted by FDA:  4/2009


Robert B. Clark
Vice-President, US Regulatory
Pfizer Inc. 
235 East 42nd Street
New York, New York 10017
 

RE:  NDA No. 20-753 AROMASIN® (exemestane) tablets
       NDA No. 21-540 CADUET® (amlodipine besylate/atorvastatin calcium) Tablets
       NDA No. 21-928 CHANTIX® (varenicline) Tablets
       NDA No. 21-228 Detrol® LA (tolterodine tartrate) extended release capsules
       NDA No. 21-446, 21-723, 21-724 LYRICA (pregabalin) Capsules
       NDA No. 20-998, 21-156 CELEBREX® (celecoxib) capsules
       MACMIS ID # 17311


Dear Mr. Clark:

As part of its monitoring and surveillance program, the Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S.  Food and Drug Administration (FDA) has reviewed Pfizer Incorporated’s (Pfizer) sponsored links on internet search engines (e.g., Google.com) for the following products: AROMASIN® (exemestane) (Aromasin), CADUET® (amlodipine besylate/atorvastatin calcium) (Caduet), CHANTIX® (varenicline) (Chantix), Detrol® LA (tolterodine tartrate) (Detrol LA), LYRICA (pregabalin) (Lyrica), and CELEBREX® (celecoxib) (Celebrex).  The sponsored links cited in this letter are misleading because they make representations and/or suggestions about the efficacy of Aromasin, Caduet, Chantix, Detrol LA, Lyrica, and Celebrex, but fail to communicate any risk information associated with the use of these drugs.  In addition, the sponsored link for Aromasin inadequately communicates the drug’s indication.  Furthermore, all of the sponsored links fail to use the required established name.  Thus, the sponsored links misbrand the drugs in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA implementing regulations.  See 21 U.S.C. 352(a) & (n), 321(n); 21 CFR 201.10(g)(1), 202.1(b)(1), (e)(3)(i), (ii) & (e)(6)(i).

Background

Aromasin
According to its FDA-approved product labeling (PI), Aromasin is indicated for adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to Aromasin for completion of a total of five consecutive years of adjuvant hormonal therapy.
Aromasin is indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy.

Aromasin is associated with a number of risks, as reflected in the Contraindications, Warnings, Precautions, and Adverse Reactions sections of its PI.

Caduet
According to its FDA-approved PI, Caduet (amlodipine and atorvastatin) is indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate.
The Indications and Usage section provides a detailed description of the indications for each of the drug’s two active ingredients.

Caduet is associated with a number of risks, as reflected in the Contraindications, Warnings, Precautions, and Adverse Reactions sections of its PI.

Chantix
According to its FDA-approved PI, Chantix is indicated as an aid to smoking cessation treatment.

Chantix is associated with a number of risks, as reflected in the Warnings (including a bolded warning), Precautions, and Adverse Reactions sections of its PI.

Detrol LA
According to its FDA-approved PI, Detrol LA Capsules are once daily extended release capsules indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

Detrol LA is associated with a number of risks, as reflected in the Contraindications, Precautions, and Adverse Reactions sections of its PI.

Lyrica
According to its FDA-approved PI, Lyrica is indicated, among other things, for (emphasis in original):

.  .  .  Management of neuropathic pain associated with diabetic peripheral neuropathy

.  .  .  Adjunctive therapy for adult patients with partial onset seizures
[and]

.  .  .  Management of fibromyalgia.

Lyrica is associated with a number of risks, as reflected in the Contraindications, Warnings and Precautions, and Adverse Reactions sections of its PI.

Celebrex
According to the FDA-approved PI for Celebrex:

Carefully consider the potential benefits and risks of CELEBREX and other treatment options before deciding to use CELEBREX.  Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals….

CELEBREX is indicated [among other things]:

1)  For relief of the signs and symptoms of osteoarthritis.
2)  For relief of the signs and symptoms of rheumatoid arthritis in adults.
3)  For relief of the signs and symptoms of juvenile rheumatoid arthritis in patients 2 years and older….

Celebrex is associated with a number of risks, as reflected in the Boxed Warning, Contraindications, Warnings, Precautions, and Adverse Reactions sections of its PI.

Omission of Risk Information

Promotional materials, other than reminder pieces, which include the name of the drug product but do not include indications or other representations or suggestions relative to the drug product (see 21 CFR 200.200, 201.100(f), 202.1(e)(2)(i)), are required to disclose risk and other information about the drug.  Such materials are misleading if they fail to reveal facts that are material in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials.  The sponsored links present the following claims:

 AROMASIN ® Official Site
   www.AROMASIN.com Learn about AROMASIN, a treatment for women with breast cancer.

•  CADUET ® Official Site
   CADUET.com Treat High Blood Pressure and High Cholesterol with One
   Pill.

•  CHANTIX ® from Pfizer
   www.CHANTIX.com Learn about CHANTIX ®, an aid for smoking cessation
   treatment.

•  Detrol ® LA Official Site
    www.DetrolLA.com Ask Your Dr.  About the Overactive Bladder Treatment
    Prescribed Most.

•  LYRICA ® Official Site
   www.LYRICA.com Diabetic Nerve Pain, Add-on for Partial Seizures &
   Fibromyalgia.

•  CELEBREX ® Official Site
   www.CELEBREX.com Review Arthritis Signs, Symptoms & Discuss
   CELEBREX® With Your Doctor.

These sponsored links make representations and/or suggestions about the efficacy of Aromasin, Caduet, Chantix, Detrol LA, Lyrica, and Celebrex, respectively, but fail to communicate any risk information.  This omission of risk information is particularly concerning as one of these products, Celebrex, has a Boxed Warning and another product, Chantix, has a bolded warning.  For promotional materials to be truthful and non-misleading, they must contain risk information in each part as necessary to qualify any claims made about the drug.

By omitting the most serious and frequently occurring risks associated with the drugs promoted in the links above, the sponsored links misleadingly suggest that Aromasin, Caduet, Chantix, Detrol LA, Lyrica, and Celebrex are safer than has been demonstrated.  We note that these sponsored links contain a link to the products’ websites.  However, this is insufficient to mitigate the misleading omission of risk information from these promotional materials.

Inadequate Communication of Indication

The sponsored link for Aromasin provides a very brief statement about what the drug is for; however, this statement is incomplete and misleading, suggesting that Aromasin is useful in a broader range of conditions or patients than has been demonstrated by substantial evidence or substantial clinical experience.  Specifically, the sponsored link for Aromasin misleadingly broadens the indication for Aromasin by implying that the drug is approved to treat the broad population of women with breast cancer (“Learn about AROMASIN, a treatment for women with breast cancer”), when this is not the case.  Rather, Aromasin’s indication is limited to postmenopausal women with breast cancer in particular settings (i.e., the adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to Aromasin for completion of a total of five consecutive years of adjuvant hormonal therapy, and advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy).

Failure to Use Required Established Name

None of the sponsored links present the full established name of the drugs being promoted, despite the requirement to do so.  See 21 CFR 201.10(g)(1) & 202.1(b)(1).

Conclusions and Requested Action

For the reasons discussed above, the sponsored links misbrand Aromasin, Caduet, Chantix, Detrol LA, Lyrica, and Celebrex in violation of the Act and FDA regulations.  See 21 U.S.C.  352(a) & (n), 321(n); 21 CFR 201.10(g)(1), 202.1(b)(1), (e)(3)(i), (ii) & (e)(6)(i).

DDMAC requests that Pfizer immediately cease the dissemination of violative promotional materials for Aromasin, Caduet, Chantix, Detrol LA, Lyrica and Celebrex, such as those described above.  Please submit a written response to this letter on or before April 9, 2009, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) in use for these drugs as of the date of this letter, identifying which of these materials contain violations such as those described above, and explaining your plan for discontinuing use of such materials.  Finally, we encourage you to review your promotional materials for the other prescription drug products that Pfizer promotes in the United States and to discontinue or revise any materials with the same or similar violations, and request that your response address this issue as well.

Please direct your response to the undersigned at the Food and Drug Administration, Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, 5901-B Ammendale Road, Beltsville, MD, facsimile at 301-847-8444.  In all future correspondence regarding this matter, please refer to MACMIS # 17311 in addition to the NDA numbers.  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 Aromasin, Caduet, Chantix, Detrol LA, Lyrica and Celebrex comply with each applicable requirement of the Act and FDA implementing regulations.


Sincerely,
 

Shefali Doshi, M.D.
Regulatory Review Officer
Division of Drug Marketing,
Advertising, and Communications

 

   
   

 

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