WARNING LETTER
Bimeda, Inc.
MARCS-CMS 542534 —
May 24, 2018
Product:
Animal & Veterinary
Recipient:
Recipient Name
Ms. Deb Voss
Bimeda, Inc.
291 Forest Prairie Road
Le Sueur
,
MN
56058
United States
Issuing Office:
Center for Veterinary Medicine
United States
Center for Veterinary Medicine
7500 Standish Place
Rockville, MD 20855
Ms. Deb Voss
Regulatory Affairs Specialist, Post-Approval
Bimeda, Inc
291 Forest Prairie Road
Le Sueur, MN 56058
MAY 24, 2018
RE:
ANADA 200-481
OVAMED (altrenogest) Solution 0.22%
WARNING LETTER
Dear Ms. Voss,
The U.S. Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), has reviewed an advertisement for OVAMED (altrenogest) Solution 0.22% in the publication "The Practitioner," published by the Florida Association of Equine Practitioners
1
, Issue 3-2017 (
https://issuu.com/fvma_faep/docs/practitioner_issue_3_issuu
). This advertisement was submitted to FDA on October 10, 2017, under the cover of Form FDA 2301.
This advertisement is false or misleading because it omits important risk information associated with the use of OVAMED. This advertisement creates a misleading impression about the safety of OVAMED for people handling and administering the drug product. Thus, this advertisement causes OVAMED to be misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 21 U.S.C. 352(n); 321 (n). The introduction of a misbranded drug into interstate commerce is a violation of section 301 of the FD&C Act. 21 U.S.C. 331 (a).
Background
Below are the indication and summary of the most serious and most common risks to people handling OVAMED.
According to the FDA-approved product labeling:
INDICATIONS:
OVAMED® (altrenogest) Solution 0.22% is indicated to suppress estrus in mares. Suppression of estrus allows for a predictable occurrence of estrus following drug withdrawal. This facilitates the attainment of regular cyclicity during the transition from winter anestrus to the physiological breeding season. Suppression of estrus will also facilitate management of prolonged estrus conditions. Suppression of estrus may be used to facilitate scheduled breeding during the physiological breeding season.
PRECAUTIONS:
Various synthetic progestins, including altrenogest, when administered to rats during the embryogenic stage of pregnancy at doses manyfold greater than the recommended equine dose caused fetal anomalies, specifically masculinization of the female genitalia.
WARNING
: For oral use in horses only. Keep this and all other medications out of the reach of children. Do not use in horses intended for human consumption.
HUMAN WARNINGS:
Skin contact must be avoided as OVAMED® (altrenogest) Solution 0.22% is readily absorbed through unbroken skin. Protective gloves must be worn by all persons handling this product.
Pregnant women or women who suspect they are pregnant should not handle OVAMED® (altrenogestl Solution 0.22%.
[Bolding and underline emphasis are consistent with approved label.] Women of child bearing age should exercise extreme caution when handling this product. Accidental absorption could lead to a disruption of the menstrual cycle or prolongation of pregnancy. Direct contact with the skin should therefore be avoided. Accidental spillage on the skin should be washed off immediately with soap and water.
INFORMATION FOR HANDLERS:
WARNING:
OVAMED® (altrenogest) Solution 0.22% is readily absorbed by the skin. Skin contact must be avoided; protective gloves must be worn when handling this product.
Effects of Overexposure:
There has been no human use of this specific product. The information contained in this section is extrapolated from data available on other products of the same pharmacological class that have been used in humans. Effects anticipated are due to the progestational activity of altrenogest.
Acute effects after a single exposure are possible; however, continued daily exposure has the potential for more untoward effects such as disruption of the menstrual cycle, uterine or abdominal cramping, increased or decreased uterine bleeding, prolongation of pregnancy and headaches. The oil base may also cause complications if swallowed.
In addition, the list of people who should not handle this product is based upon the known effects of progestins used in humans on a chronic basis.
PEOPLE WHO SHOULD NOT HANDLE THIS PRODUCT.
1. Women who are or suspect they are pregnant.
2. Anyone with thrombophlebitis or thromboembolic disorders or with a history of these events.
3. Anyone with cerebral-vascular or coronary-artery disease.
4. Women with known or suspected carcinoma of the breast.
5. People with known or suspected estrogen-dependent neoplasia.
6. Women with undiagnosed vaginal bleeding.
7. People with benign or malignant tumors which developed during the use of oral contraceptives or other estrogen-containing products.
8. Anyone with liver dysfunction or disease.
Accidental Exposure:
Altrenogest is readily absorbed from contact with the skin. In addition, this oil based product can penetrate porous gloves. Altrenogest should not penetrate intact rubber or impervious gloves; however, if there is leakage (i.e., pinhole, spillage, etc.), the contaminated area covered by such occlusive materials may have increased absorption. The following measures are recommended in case of accidental exposure.
Skin Exposure:
Wash immediately with soap and water.
Eye Exposure:
Immediately flush with plenty of water for 15 minutes. Get medical attention.
If Swallowed:
Do not induce vomiting. OVAMED® (altrenogest) Solution 0.22% contains an oil. Call a physician. Vomiting should be supervised by a physician because of possible pulmonary damage via aspiration of the oil base. If possible bring the container and labeling to the physician.
The advertisement in The Practitioner, cited above, presents only a brief risk statement in very small print at the bottom of the ad that states: "FOR ORAL USE IN HORSES ONLY. Pregnant women or women who suspect they are pregnant should not handle OvaMed. Protective gloves must be worn by all persons handling this product. Refer to the product sheet for comprehensive product information."
Omission and Minimization of Risk Information
Promotional materials are misleading if they fail to reveal facts material in light of the representations made or with respect to consequences that may result from the use of the drug as recommended or suggested in the materials. 21 U.S.C. 321 (n).
The advertisement published in The Practitioner is misleading because it omits important risks associated with use of OVAMED that are described in the precautions and warnings sections. Omission of human user warnings, and other safety information, is misleading because this advertisement does not communicate material facts relating to warnings necessary to mitigate the serious exposure risks that the product poses for human users. Thus, this advertisement does not satisfy the requirement that it present a "true statement" of information in brief summary relating to contraindications. 21 CFR 202.1 (e)(5). The risk information that is included in the advertisement is only a brief risk statement in very small print in the ad. As such, the advertisement fails to provide sufficient emphasis for the information relating to side effects and contraindications because of emphasis in the advertisement of claims for safety or effectiveness of the drug. 21 CFR 202.1(e)(7)(vii). In addition, the advertisement fails to present information relating to side effects and contraindications with a prominence and readability comparable with the presentation of information relating to effectiveness of the drug. 21 CFR 202.1 (e)(7)(viii). This omission of human user warning and other safety information and minimization of risk information causes the product to be misbranded. See 21 U S.C. 352(n) and 321(n).
Conclusion and Requested Action
For the reasons discussed above, the advertisement causes OVAMED to be misbranded within the meaning of the FD&C Act. 21 U.S.C. 352(n); 321 (n). The introduction of a misbranded drug into interstate commerce is a violation of section 301 of the FD&C Act. 21. USC. 331(a).
CVM requests that Bimeda, Inc. immediately cease misbranding OVAMED, and/or cease introducing the misbranded drug into interstate commerce.
Please submit a written response within fifteen (15) calendar days of receipt of this letter, describing how you intend to comply with this request, listing all promotional materials (with the Form FDA 2301 submission date) for OVAMED that contain presentations such as those described above, and explaining your plan for discontinuing use of such materials, or, in the alternative, for ceasing distribution of OVAMED. Because the violations described above are serious, we request, further, that your submission include a comprehensive plan of action to disseminate truthful, nonmisleading, and complete corrective messages about the issues discussed in this letter to the audience(s) that received the violative advertisements. In order to clearly identify the violative promotional piece(s) and/or activity and focus on the corrective message(s), CVM recommends that corrective piece(s) include a description of the violative promotional piece(s) and/or activity, include a summary of the violative message(s), provide information to correct each of the violative message(s), and be free of promotional claims and presentations. To the extent possible, corrective messaging should be distributed using the same media, and generally for the same duration of time and with the same frequency that the violative promotional material was disseminated.
If you cannot complete corrective action within 15 calendar days, state the reason for the delay and the time within which you will complete the correction.
Please direct your response to Dr. Neal Bataller at the Food and Drug Administration, Center for Veterinary Medicine, Division of Surveillance, HFV-216, 7519 Standish Place, Rockville, Maryland 20855.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to assure that the promotional materials for OVAMED comply with all the requirements of the FD&C Act and applicable FDA regulations.
Failure to correct the violations discussed above may result in enforcement action by FDA, including seizure or injunction, without further notice.
Sincerely,
/S/
Neal Bataller, ME, DVM
Director, Division of Surveillance
Office of Surveillance & Compliance
Center for Veterinary Medicine
________________________
1
The Florida Association of Equine Practitioners is an Equine -Exclusive Division of the Florida Veterinary Medical Association.
Content current as of:
07/03/2018
Regulated Product(s)
Animal & Veterinary