SUBJ: MMQC-03-1093
HHS ACTS TO REDUCE POTENTIAL RISKS OF DIETARY SUPPLEMENTS CONTAINING EPHEDRA/ INFORMATION BULLETIN

FOLLOWING ARE EXCERPTS FROM "FDA NEWS," FEB 28, 2003
(HTTP://WWW.FDA.GOV/BBS/TOPICS/NEWS/2003/NEW00875.HTML)

1. THE DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) TODAY ANNOUNCED A SERIES OF ACTIONS DESIGNED TO PROTECT AMERICANS FROM POTENTIALLY SERIOUS RISKS OF DIETARY SUPPLEMENT PRODUCTS CONTAINING EPHEDRA. THE RESULTS OF A RAND CORPORATION STUDY COMMISSIONED BY THE NATIONAL INSTITUTES OF HEALTH, AS WELL AS OTHER RECENT STUDIES, PROVIDE ADDITIONAL EVIDENCE THAT EPHEDRA MAY BE ASSOCIATED WITH IMPORTANT HEALTH RISKS. THE RAND REPORT ALSO FINDS ONLY LIMITED EVIDENCE OF HEALTH BENEFITS RESULTING FROM EPHEDRA USE.

2. ON THE BASIS OF NEW EVIDENCE IN THE MEDICAL LITERATURE AND IN ADVERSE EVENT REPORTS, THERE ARE REASONS FOR HEIGHTENED CONCERN THAT DIETARY SUPPLEMENTS CONTAINING EPHEDRA MAY PRESENT A SIGNIFICANT AND UNREASONABLE RISK OF ILLNESS AND INJURY.

3. TO PROTECT AMERICANS FROM THE POTENTIALLY SERIOUS RISKS OF THESE DIETARY SUPPLEMENTS, HHS AND FDA ARE GOING TO:

--SEEK RAPID PUBLIC COMMENT ON THE NEW EVIDENCE ON HEALTH RISKS ASSOCIATED WITH EPHEDRA TO ESTABLISH AN UP-TO-DATE RECORD AS QUICKLY AS POSSIBLE TO SUPPORT NEW RESTRICTIONS ON EPHEDRA-CONTAINING PRODUCTS.

--SEEK RAPID PUBLIC COMMENT ON WHETHER THE CURRENTLY AVAILABLE EVIDENCE AND MEDICAL LITERATURE PRESENT A "SIGNIFICANT OR UNREASONABLE RISK OF ILLNESS OR INJURY" FROM DIETARY SUPPLEMENTS CONTAINING EPHEDRA.

--SEEK RAPID COMMENT ON A STRONG NEW WARNING LABEL ON ANY EPHEDRA PRODUCTS THAT CONTINUE TO BE MARKETED

--IMMEDIATELY EXECUTE A SERIES OF ACTIONS AGAINST EPHEDRA PRODUCTS MAKING UNSUBSTANTIATED CLAIMS ABOUT SPORTS PERFORMANCE ENHANCEMENT

4. IN ADDITION, THE NATION'S TOP PUBLIC HEALTH OFFICIALS ISSUED STRONG STATEMENTS CAUTIONING ABOUT THE USE OF EPHEDRA-CONTAINING PRODUCTS, ESPECIALLY UNDER CONDITIONS OF STRENUOUS EXERCISE AND IN COMBINATION WITH OTHER STIMULANTS, INCLUDING CAFFEINE.

"WE WANT TO CAUTION ALL AMERICANS - PARTICULARLY ATHLETES AND THOSE WHO ENGAGE IN STRENUOUS ACTIVITIES - ABOUT USING DIETARY SUPPLEMENTS THAT CONTAIN EPHEDRA," SAID SECRETARY OF HEALTH AND HUMAN SERVICES TOMMY G. THOMPSON. "THERE CONTINUE TO BE SERIOUS QUESTIONS ABOUT THE RISKS SURROUNDING THIS PARTICULAR DIETARY SUPPLEMENT."

5. EVIDENCE IS ACCUMULATING ABOUT POTENTIALLY SERIOUS SAFETY PROBLEMS FOLLOWING THE USE OF EPHEDRA-CONTAINING PRODUCTS. THE RAND STUDY HAS CONCLUDED THAT EPHEDRA IS ASSOCIATED WITH HIGHER RISKS OF MILD TO MODERATE SIDE EFFECTS SUCH AS HEART PALPITATIONS, PSYCHIATRIC AND UPPER GASTROINTESTINAL EFFECTS, AND SYMPTOMS OF AUTONOMIC HYPERACTIVITY SUCH AS TREMOR AND INSOMNIA, ESPECIALLY WHEN IT IS TAKEN WITH OTHER STIMULANTS.

6. IN ADDITION, FDA TODAY PROPOSED A WARNING LABEL FOR ALL EPHEDRA-CONTAINING DIETARY SUPPLEMENTS. THE PROPOSED LABEL WARNS ABOUT THE RISKS OF SERIOUS ADVERSE EVENTS, INCLUDING HEART ATTACK, SEIZURE, STROKE, AND DEATH; CAUTIONS

THAT THE RISK CAN INCREASE WITH THE DOSE, WITH STRENUOUS EXERCISE, AND WITH OTHER STIMULANTS SUCH AS CAFFEINE; SPECIFIES CERTAIN GROUPS (SUCH AS WOMEN WHO ARE PREGNANT OR BREAST FEEDING) WHO SHOULD NEVER USE THESE PRODUCTS; AND LISTS OTHER CONDITIONS, SUCH AS DISEASES AND THE USE OF CERTAIN MEDICATIONS, THAT RULE OUT THE USE OF EPHEDRINE ALKALOIDS.

7. ADDITIONAL MATERIALS ABOUT THE RISKS OF PRODUCTS CONTAINING EPHEDRINE ALKALOIDS, INCLUDING A MORE TECHNICAL FDA "WHITE PAPER," MAY BE FOUND ON FDA'S WEBSITE AT THE FOLLOWING ADDRESSES:

WHITE PAPER (WWW.FDA.GOV/BBS/TOPICS/NEWS/EPHEDRA/WHITEPAPER.HTML)
FACT SHEET (WWW.FDA.GOV/BBS/TOPICS/NEWS/EPHEDRA/FACTSHEET.HTML)
SAMPLE WARNING LETTER (WWW.FDA.GOV/BBS/TOPICS/NEWS/EPHEDRA/WARNING.HTML)
FEDERAL REGISTER (WWW.FDA.GOV/OHRMS/DOCKETS/

8. PASS MSG TO MEDICAL LOG OFCRS, CMD CHANNELS, PHARMACY, DIETITIANS, MED STAFF SECTION, SUPPLY OFCRS, PREVENTIVE MEDICINE/ENVIRONMENTAL SCIENCE OFCRS, HEALTH SERVICES MAINTENANCE TECHS, AND SUPPORTED ACTYS/CTRS.

9. AIR FORCE: SEE AFMAN 23-110, VOL 5, FOR REQUIRED ACTIONS. FOR MAJCOMS & NGB--THIS MSG HAS BEEN TRANSMITTED TO ALL DESIGNATED SUBORDINATE MEDICAL ACTIVITIES IAW AFMAN 23-110, VOL 5, CHAP 19.

10. SVC SPECIFIC POCS ARE AS FOLLOWS (FAX NOS. ARE AVAILABLE 24 HRS):

ARMY: PAULA THORN, 301-619-4305/2045, DSN: 343, FAX 2938,
E-MAIL: Paula.Thorn@amedd.army.mil
ARMY MEMBERS MAY SUBSCRIBE TO THE DODMMQC MESSAGES AND MANY OTHER TOPICS
AT THE FOLLOWING WEBSITE: WWW.USAMMA.ARMY.MIL.
CLICK ON "SUBSCRIBE TO MMQC MESSAGES."

USAMMCE: HORST WERNER, COM: 011-49-6331-86-7118/7181, DSN: 495-7118,
FAX: X6218, E-MAIL: HORST.WERNER@AMEDD.ARMY.MIL

AIR FORCE: MS JAN MITCHELL, 301-619-4170; DSN: 343, FAX 6842
E-MAIL: JAN.MITCHELL@FT-DETRICK.AF.MIL
AIR FORCE MEMBERS MAY SUBSCRIBE TO THE DODMMQC MESSAGES AND MANY OTHER
TOPICS AT THE FOLLOWING WEBSITE: HTTPS://AFML.FT-DETRICK.AF.MIL/AFMLO/LISTSERVER/ENDUSE.CFM. THE LIST SERVER CATEGORY IS CALLED "DOD MEDICAL MATERIEL QUALITY CONTROL (DODMMQC)."

NAVY: HMC JOHN BROWN, 301-619-3088, DSN: 343, FAX 3087,
E-MAIL: JBROWN@NMLC.MED.NAVY.MIL