a chinese herbal weight loss product adulterated with fenfluramine
TRANSCRIPT
regulations on the safe manufacture of drugs by‘‘compounding’’ in bulk.
The practice of compounding N-acetylcysteine oral solutionfor intravenous administration is supported by at least 12 yearsof published and unpublished experience and can hardly beconsidered ‘‘copying’’ the newly approved product. Individualstate pharmacy boards may differ on the issue of whether it isappropriate to continue this practice after introduction of anFDA-approved intravenous dosing form. We agree thatphysicians, pharmacists, and poison control centers are welladvised to seek this information, in advance, from theirhospitals’ legal counsel or state pharmacy board.
Eric J. Lavonas, MDMichael C. Beuhler, MDMarsha D. Ford, MDWilliam P. Kerns, II, MDAnna M. Rouse, PharmDChristian A. Tomaszewski, MDMary A. Wittler, MDDivision of Medical ToxicologyDepartment of Emergency MedicineCarolinas Poison CenterCarolinas Medical CenterCharlotte, NC
doi:10.1016/j.annemergmed.2005.03.020
1. FDA Modernization Act of 1997, Section 127. Available at: http://www.fda.gov/cder/guidance/105-115.htm#SEC.%20127. AccessedMarch 14, 2005.
2. Federal Food, Drug, and Cosmetic Act, 21 US Code, x353a. Availableat: http://www.gpoaccess.gov/uscode. Accessed March 14, 2005.
Correspondence
A Chinese Herbal Weight Loss ProductAdulterated With Fenfluramine
To the Editor:Harmful adulterants in the form of heavy metals and
conventional drugs may be present in herbal products.1,2 Weobserved a case of fenfluramine poisoning in a patient whoingested an herbal weight loss product.
A previously healthy 31-year-old woman was foundcomatose beside an empty bottle of an herbal weight-lossproduct. A total of 120 10-mg tablets were missing. Shepresented to the emergency department comatose, afebrile,tachycardic (120 beats/min), hypotensive (blood pressure 80/60mm Hg), and in need of airway protection. Eye examinationshowed 8-mm pupils bilaterally, with horizontal nystagmus.Extremities were moderately hypertonic and rigid. Significantlaboratory test results included an anion gap of 18, undetectableserum salicylates and acetaminophen, and a quantitative urinetoxicology screen positive for amphetamines. The patient hadan uncomplicated course and was extubated 2 days after
208 Annals of Emergency Medicine
admission. Confirmatory serum levels of fenfluramine andnorfenfluramine were 2,480 ng/mL (therapeutic 35 to380 ng/mL) and 330 ng/mL (steady state levels after daily doses60 to 160 ng/mL) by gas chromatography/mass spectroscopyrespectively. The patient reported purchasing the ‘‘weight lossproduct’’ from a local Chinese herbalist.
Our case illustrates some of the manifestations of acutepoisoning as a result of fenfluramine. Fenfluramine, a racemicmixture of dextro- and levofenfluramine, was historicallyprescribed in combination with phentermine for weight loss.3
The US Food and Drug Administration removed fenfluraminefrom the market in 1997 because of a significant associationwith valvular heart disease and pulmonary hypertension,resulting in critical morbidity and mortality.4
Other reports have cautioned that herbal medicineshave been adulterated with toxins such as bannedpesticides, dangerous chemicals, and microbial contaminants.5
This case demonstrates poisoning from a Chinese herbalproduct adulterated with a banned Western pharmaceuticalagent. Physicians should be aware that herbal productscould be adulterated with a variety of injurious poisons.Legislation supporting the screening of herbal supplementsfor synthetic drugs may help avert potentially serious harm toconsumers.
Sean M. Bryant, MDCook County HospitalDepartment of Emergency MedicineToxikon ConsortiumIllinois Poison CenterChicago, IL
Connie Lozada, MDCook County HospitalDepartment of Emergency MedicineChicago, IL
Mike Wahl, MDIllinois Poison CenterChicago, IL
doi:10.1016/j.annemergmed.2005.03.021
1. Saper RB, Kales SN, Paquin J, et al. Heavy metal content ofayurvedic herbal medicine. JAMA. 2004;292:2868-2873.
2. Ernst E. Adulteration of Chinese herbal medicines with syntheticdrugs: a systematic review. J Intern Med. 2002;252:107-113.
3. Wellman PJ, Maher TJ. Synergistic interactions between fenfluramineand phentermine. Int J Obes. 1999;23:723-732.
4. Rich S, Shillington A, McLaughlin V. Comparison of survival inpatients with pulmonary hypertension associated with fenfluramineto patients with primary pulmonary hypertension. Am J Cardiol. 2003;92:1366-1368.
5. Chan K. Some aspects of toxic contaminants in herbal medicines.Chemosphere. 2003;52:1361-1371.
Volume 46, no. 2 : August 2005