Elanco Animal Health Warned On Dog Anxiety Medicine Advertisement

Reconcile

The FDA has issued a warning letter to Elanco Animal Health about misleading advertisements, sales brochures, and product website for Reconcile, a medicine used to treat separation anxiety in dogs.

The June warning letter states that these promotional pieces have incomplete information concerning the effectiveness of the drug. The FDA states that the company is claiming that Reconcile is more effective than it has demonstrated, thus the drug is being misbranded.

The article “Separation Anxiety: A Brief Overview” contains the following statement:

“In a clinical field trial, 73 percent of dogs receiving ReconcileTM showed significant improvement within eight weeks, compared to placebo-treated animals, and 42 percent of dogs receiving ReconcileTM showed significant improvement within one week compared to placebo-treated animals.”

The above-quoted statements fail to disclose that the dogs in the comparison group were treated with behavior modification and did not just receive a placebo. The article “Separation Anxiety: A Brief Overview” additionally fails to disclose that the dogs receiving Reconcileâ„¢ in the study had also been treated with behavior modification. Moreover, the materials do not state that for the dogs in the comparison group, which received a placebo and were treated with behavior modification, 51% showed significant improvement by the end of the eight week study and 18% showed significant improvement within the first week.

We’ve posted the full warning letter.

(Thanks Irene)

JUN 26 2007

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

NADA 141-272 (L0017)

Margaret Gillis
Regulatory Associate
Elanco Animal Health
2001 W. Main Street, DC GL21
Greenfield, IN 46140

RE: NADA 141-272 Reconcileâ„¢ (fluoxetine hydrochloride);
promotional pieces and product website (reconcile.com).

Dear Ms. Gillis:

We, the Division of Surveillance, Center for Veterinary Medicine, have reviewed the article “Separation Anxiety: A Brief Overview” for Reconcileâ„¢, NADA 141-272, submitted by Elanco Animal Health under cover of form FDA 2301 dated May 04, 2007. We also reviewed the reconcile.com website. In addition, the Division of Surveillance has reviewed a promotional piece RE00053 (consumer brochure) and a print advertisement REC005305 (in the May issue of Veterinary Forum Magazine). These pieces and the product website are misleading due to incomplete information concerning the effectiveness of Reconcileâ„¢. These pieces and the product website suggest that the product is more effective than has been demonstrated. Therefore, the drug is misbranded within the meaning of sections 502(n) and 201(n) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 352(n) and 321(n)].

Background

Reconcileâ„¢ (fluoxetine hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of canine separation anxiety in conjunction with a behavior modification plan.

The approved package insert contains the following statements:

“At the end of the 8-week study, 73% of dogs treated with Reconcile chewable tablets showed significant improvement (p=0.010), as compared to behavior modification alone (51%). During the course of therapy, 42% of dogs showed improvement within the first week, which was significantly greater (p=0.005) than with behavior modification alone (18%).”

and

“At the end of the study, 73% of dogs treated with RECONCILE chewable tablets showed significant improvement (p= 0.010) as compared to 51% of dogs treated with behavior modification alone.”

Failure to reveal material facts

The article “Separation Anxiety: A Brief Overview” contains the following statement:

“In a clinical field trial, 73 percent of dogs receiving ReconcileTM showed significant improvement within eight weeks, compared to placebo-treated animals, and 42 percent of dogs receiving ReconcileTM showed significant improvement within one week compared to placebo-treated animals.”

The Reconcileâ„¢ website and the consumer brochure for Reconcileâ„¢ (RE00053) contain the following statements:

• 73% of dogs receiving Reconcile™ showed significant improvement within eight weeks compared to placebo-treated animals.

• 42% of dogs receiving Reconcile™ showed significant improvement within one week compared to placebo-treated animals.

The print advertisement in the May issue of Veterinary Forum Magazine (REC005305) contains the following statements:

• 73% of dogs showed significant improvement within eight weeks compared to placebo-treated animals.

• 42% of dogs showed significant improvement within one week compared to placebo-treated animals.

The above-quoted statements fail to disclose that the dogs in the comparison group were treated with behavior modification and did not just receive a placebo. The article “Separation Anxiety: A Brief Overview” additionally fails to disclose that the dogs receiving Reconcileâ„¢ in the study had also been treated with behavior modification. Moreover, the materials do not state that for the dogs in the comparison group, which received a placebo and were treated with behavior modification, 51% showed significant improvement by the end of the eight week study and 18% showed significant improvement within the first week. Failing to reveal this information makes the above quoted statements misleading because they suggest that Reconcileâ„¢ is more effective than has been demonstrated by substantial evidence or substantial clinical experience. The article also fails to disclose that claimed results may be due to a concomitant therapy, behavior modification.

In a teleconference on April 23, 2007, CVM spoke with representatives from Elanco Animal Health to discuss Dear Doctor letters (RE00062-041707 and RE00000-41707) that were to be sent to veterinarians and veterinary clinics. These letters contained similar effectiveness claims as in the labeling and advertisement quoted above. CVM requested the Dear Doctor letters be revised to more accurately reflect the approved label. At that time, Elanco agreed to revise the Dear Doctor letters. On May 1, 2007, Elanco sent revised Dear Doctor letters (RE00062-042407 and RE00064-05xx07) electronically to CVM. These Dear Doctor letters contained the following revised statements:

“• Within eight weeks, 73% of dogs treated with Reconcileâ„¢ chewable tablets showed significant improvement as compared to behavior modification alone (51%).”

“• 42% of dogs showed improvement within the first week, which was significantly greater than with behavior modification alone (18%).”

As previously conveyed to Elanco, CVM finds these revised statements, which disclose the fact that within 8 weeks, 51 % of dogs showed significant improvement with behavior modification alone, acceptable.

Conclusion and Requested Actions

As discussed above, the claims made in these pieces and the product website are misleading and cause the drugs to be misbranded within the meaning of sections 502(n) and 201(n) of the Act [21 U.S.C. 352(n) and 321(n)] and FDA implementing regulations at 21 CFR 202.1(e)(6)(i) and (vi).

The Division of Surveillance requests that Elanco Animal Health immediately cease the dissemination of the violative pieces for Reconcileâ„¢ such as those described above. Future promotional labeling and advertisements should not overstate the effectiveness of Reconcileâ„¢. Because the violations described above are serious, we request that Elanco submit a comprehensive plan of action to disseminate a truthful, non-misleading and complete corrective message about the issue discussed in this letter to the audience(s) that received the violative materials.

Elanco should notify this office in writing within fifteen (15) working days of receiving this letter of the steps it has taken to bring the Reconcileâ„¢ website and other material into compliance with the law. The response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to see that the labeling and advertisements for Reconcileâ„¢ (fluoxetine hydrochloride), as well as other Elanco Animal Health products, comply with the requirements of the Act and FDA implementing regulations. Failure to correct the violations discussed above may result in FDA regulatory action without further notice such as seizure and/or injunction.

If you have any questions, please contact me at the address above, or call me at (240) 276-9061. All future written correspondence regarding this matter should reference our file number NADA 141-272 (L0017).

Sincerely yours,

/S/

Lynn O. Post, D.V.M., PhD, DABVT
Director, Division of Surveillance
Center for Veterinary Medicine

One Response to “Elanco Animal Health Warned On Dog Anxiety Medicine Advertisement”

  1. menusux says:

    This product is basically flavored Prozac (fluoxetine)–re-packaged for the veterinary market; Elanco is the Animal Health division of Eli Lilly. The patent on the human form of it expired a while back; this meant that other drug companies could produce it under its generic name, fluoxetine.

    Lilly has re-worked the drug in countless ways–combining it with another antidepressant drug as Symbyax, pushing another lesser strength of it as Sarafem for PMS, etc.

    http://www.mercola.com/2001/jun/20/sarafem%20.htm

    Prozac Profit Ploy-Rename & Sell as Sarafem

    The truth is that this is a potent antidepressant with OODLES of baggage–the drug has been labeled responsible for many murder/suicides which made the news, as well as many private and class action lawsuits because of it.

    http://www.justiceseekers.com/.....trow/7.htm

    Justice Seekers–Attorney Who is Lilly’s Foe

    Dr. David Healy is a well-known psychiatrist who points out the medical flaws of the drug:

    http://en.wikipedia.org/wiki/David_Healy_(psychiatrist)

    http://www.ahrp.org/infomail/05/01/27.php

    Alliance for Human Research Protection–Prozac Documents Revealed

    http://www.healyprozac.com/

    Let Them Eat Prozac–Dr. David Healy

    Prozac was, at one time, their major moneymaker, so they’ve worked tirelessly at finding ways to recycle it to keep the $ coming. Lilly also has a laundry list of infractions regarding promoting their drugs–off label (when the drug is promoted for a use other than which it was approved for), false claims about their products, less than honest marketing tactics, etc. They went far enough to create a pseudo-task force to promote their sepsis drug:

    http://www.boston.com/business.....ting_push/

    Article questions Eli Lilly marketing push October 19, 2006 Boston Globe

    The latest involves their antipsychotic drug Zyprexa–this one’s been in the news for quite a while:

    http://ahrp.blogspot.com/2006/.....lilly.html

    Eli Lilly Documents Show Lilly Promoted Zyprexa for Unapproved Use

    Veterinary medicine did not need Reconcile–because if a doctor believed fluoxetine/Prozac was warranted, all that was necessary was for him/her to write a prescription for it and it would be filled at a pharmacy of the client’s choice.

    Have a look at the drug information for both Reconcile and Prozac–you’ll see there’s PLENTY of adverse effects detailed on the Prozac (human) form of the drug, while Lilly makes them seem a lot less serious on the Reconcile one:

    http://www.fda.gov/OHRMS/DOCKE.....001-03.pdf

    http://www.fda.gov/OHRMS/DOCKE.....001-02.pdf

    Reconcile

    http://www.fda.gov/medwatch/SA.....zac_PI.pdf

    Prozac–Here you see the “black box” (VERY serious) warning regarding young people and suicide while on the drug.

    This company has played fast and loose with the truth about their products for many years. Take a look at where pharmaceutical reps who sell these products have a message board–you’ll see that a common term for the company is “We Lie Lilly”.

    http://tinyurl.com/2jf2h3

    My happiest day was when we no longer needed any of their products, having obtained the needed drug from a reputable pharma.


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