SEIZURE ACTIVITY AND UNRESPONSIVENESS AFTER HYDROXYCUT Kockler et al
651
2. Eisenberg DM, Davis RB, Ettner SL, et al. Trends in alternative
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Conclusion
This case report describes an episode of
seizure-like activity in a previously healthy,
young man after several weeks of Hydroxycut
consumption. Daily intake of ma huang
(ephedra) by this patient was 60 mg, which
exceeds the FDA’s proposed maximum for daily
consumption of ephedra alkaloids (24 mg). In
addition, the patient’s intake of caffeine was more
than 600 mg/day. The combination of ephedra
alkaloids and caffeine in Hydroxycut may have
resulted in a synergistic effect, contributing to
sympathomimetic toxicities. The product does
not comply with the FDA’s 1997 or most recent
proposed regulations for ephedra alkaloids.
5. Boullata JI, Nance AM. Safety issues with herbal medicine.
Pharmacotherapy 2000;20:257–69.
6. U.S. Food and Drug Administration. Illnesses and injuries
associated with the use of selected dietary supplements. FDA,
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vm.cfsan.fda.gov/~dms/ds-ill.html. Accessed August 24, 2000.
7. Kurtzweil P. An FDA guide to dietary supplements. US Food
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8. Muscletech Research and Development, Inc. Hydroxycut
product information. Brampton, Ontario, Canada; available
from viastorm.com/products/hydroxycut.asp. Accessed
September 5, 2000.
The Naranjo score,27 which assesses the
causality of drug-related adverse events, in this
patient was 6, indicative of a probable ADR
(Table 2). Although many case reports describe
cardiovascular and nervous system effects of
products containing ephedra alkaloids, this is the
first case report of seizure due to Hydroxycut.
This case report supports the need for regulation
of products containing ephedra alkaloids. Due to
the increase in demand and the lack of regulation
of herbal products, it is imperative that health
care providers actively question and educate
patients about the use of herbal products. All
suspected ADRs resulting from alternative
medicine or dietary supplements, regardless of
causality, should be reported to the FDA’s
MedWatch program or to the Special Nutritionals
Adverse Event Monitoring System (SN/AEMS),
an FDA database of adverse events associated
with “use of a special nutritional product:
dietary supplements, infant formulas, and
medical foods.”3 With more knowledge of
postmarketing adverse effects, health care
providers can inform consumers and make
recommendations more accurately than before
about the safety of herbal products.
9. DerMarderosian A, ed. The ephedras. In: The review of natural
products. St. Louis: Facts and Comparisons, 1989.
10. Centers for Disease Control and Prevention. Adverse events
associated with ephedrine-containing products—Texas,
December 1993–September 1995. MMWR 1996;45:689–92.
11. Wooten MR, Khangure MS, Murphy MJ. Intracerebral
hemorrhage and vasculitis related to ephedrine abuse. Ann
Neurol 1983;13:337–40.
12. Anonymous. FDA proposes constraints on ephedrine dietary
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14. Miller, JL. FDA backs away from elements of plan to regulate
ephedrine supplements. Am J Health-Syst Pharm 2000;57:922.
15. Haller CA, Benowitz NL. Adverse cardiovascular and central
nervous system events associated with dietary supplements
containing ephedra alkaloids. N Engl J Med 2000;343:1833–8.
16. Serafin WE. Drugs used in the treatment of asthma. In:
Hardman JG, Limbird LE, eds. Goodman & Gilman’s the
pharmacological basis of therapeutics. 9th ed. New York:
McGraw-Hill, 1996:673–9.
17. Sawynok J. Pharmacological rationale for the clinical use of
caffeine. Drugs 1995;49:37–50.
18. Abraham AS, Brooks BA, Eylath U. The effects of chromium
supplementation on serum glucose and lipids in patients with
and without non-insulin-dependent diabetes. Metabolism
1992;41:768–71.
19. Cerulli J, Grabe DW, Gauthier I, Malone M, McGoldrick MD.
Chromium picolinate toxicity. Ann Pharmacother
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20. Huszonek J. Over-the-counter chromium picolinate [letter].
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21. Chavez ML. Chromium picolinate. Hosp Pharm
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22. McCarty MF. Inhibition of citrate lyase may aid aerobic
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23. McCarty MF. Promotion of hepatic lipid oxidation and
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24. Sigma-tau Pharmaceuticals, Inc. Carnitor (levocarnitine)
package insert. Gaithersburg, MD; 1999.
25. Mueller RL, Scheidt S. History of drugs for thrombotic disease:
discovery, development, and directions for the future.
Circulation 1994;89:432–49.
26. DerMarderosian A, ed. Willow bark. In: The review of natural
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27. Naranjo CA, Busto U, Sellers EM, et al. A method to estimate
the probability of adverse drug reactions. Clin Pharmacol Ther
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Acknowledgement
The authors gratefully acknowledge Anne E.
Hendrick, Pharm.D., Director of Drug Information,
University of Virginia Health System, for her
assistance in editing the manuscript.
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