case report  Hydroxycut

c a s e  r e p o r t

Rhabdomyolysis associated with the nutritional

supplement Hydroxycut
Sarah Dehoney and Marlea Wellein

I
n May 2004, the National Center
for Complementary and Alterna-
tive Medicine reported that ap-
proximately one fifth of Americans
consume nutritional supplements,
costing $5 billion in “out-of-pocket”
dollars. 1 Despite this widespread
use, no effective mechanism exists to
educate consumers about the adverse
effects of these products.
Americans spend an average of
$30 billion a year on weight-loss
products.2 Many of these products
are nutritional supplements that
claim to help people lose weight or
increase muscle mass through various
mechanisms. However, nutritional
supplements containing ephedra,
creatine, and large doses of caffeine
(>1 g) have been reported to cause
rhabdomyolysis, a syndrome char-
acterized by muscle necrosis, whose
severity can range from muscle aches
to life-threatening situations.3-11
Rhabdomyolysis is commonly
caused by trauma, muscle overexer-
tion, hyperthermia, drugs or toxins,
infections, or metabolic or endocri-
nologic etiologies.12-16 Patients have
nonspecific symptoms, the most
common of which include muscle
Purpose. A case of rhabdomyolysis as-
sociated with the use of Hydroxycut is
reported.
Summary. An 18-year-old Caucasian man
arrived at an urgent care center complain-
ing of bilateral leg pain and weakness.
His creatine kinase (CK) concentration
was 13,220 IU/L. He was diagnosed with
rhabdomyolysis and instructed to go to
the emergency room. He admitted to
decreased urine output for four to five
days before hospital admission. He had
no significant past medical history, and
his medications before symptom onset
included Hydroxycut four caplets by mouth
daily, naproxen sodium 220 mg by mouth
as needed for pain, dextroamphetamine
saccharate–amphetamine salts (Adderall)
15 mg by mouth once five days prior for
a school examination, and hydrocodone–
acetaminophen and cyclobenzaprine for
pain. His social history revealed a recent
increase in his exercise regimen, and his
last alcoholic beverage was consumed
five days prior. Upon admission, labora-
tory tests revealed elevated concentrations
of CK, serum creatinine (SCr), aspartate
pain and weakness, dark urine, and
elevated creatine kinase (CK) lev-
els. Rhabdomyolysis can become
life threatening, causing hepatic
transaminase, alanine transaminase (ALT),
and alkaline phosphatase. The patient
was diagnosed with rhabdomyolysis and
treated with intravenous hydration. The
patient’s leg tenderness was reduced, and
he was discharged with instructions to stop
Hydroxycut, increase fluid intake, avoid
alcohol consumption, and limit physical
activity for the next week. Two weeks after
hospital discharge, the patient’s CK and
liver enzyme values returned to normal,
excluding ALT and SCr, which remained
slightly elevated, and his lower-extremity
tenderness fully resolved.
Conclusion. An 18-year-old Caucasian man
with no significant medical history devel-
oped rhabdomyolysis possibly associated
with the ingestion of Hydroxycut in addi-
tion to his increased exercise regimen.
Index terms: Acetaminophen; Amphet-
amines; Cyclobenzaprine; Dextroamphet-
amine saccharate; Dietary supplements;
Hydrocodone; Naproxen sodium; Rhab-
domyolysis; Toxicity
Am J Health-Syst Pharm. 2009: 66:142-8
inflammation, cardiac arrhythmia
and arrest, acute renal failure, dis-
seminated intravascular coagula-
tion, or compartment syndrome.

Sarah Dehoney, Pharm.D., is Emergency Department Clinical
Pharmacist, Department of Pharmacy Services, University of Utah,
Salt Lake City; at the time of writing she was Pharmacotherapy Resi-
dent, Medical Center and College of Pharmacy Residency Program,
Medical University of South Carolina, Charleston. Marlea Wellein,
Pharm.D., BCPS, is Clinical Pharmacist, Trident Medical Center,
Charleston; at the time of writing she was Assistant Professor, De-
partment of Pharmacy and Clinical Sciences, South Carolina College
of Pharmacy, Charleston.
Address correspondence to Dr. Dehoney at the Department of
Pharmacy Services, University of Utah, 50 North Medical Drive, Room
A050, Salt Lake City, UT 84132 (sarah.dehoney@hsc.utah.edu).
The authors have declared no potential conflicts of interest.
Copyright © 2009, American Society of Health-System Pharma-
cists, Inc. All rights reserved. 1079-2082/09/0102-0142$06.00.
DOI 10.2146/ajhp070640

142 Am J Health-Syst Pharm—Vol 66 Jan 15, 2009


Because rhabdomyolysis can present
in a variety of different ways, the
differential diagnosis depends on
a patient’s specific medical history,
and the diagnosis is often confirmed
by excluding other causes for the
patient’s signs and symptoms. The
primary goal of therapy is supportive
care to prevent further complica-
tions. Patients frequently require
volume resuscitation with intrave-
nous hydration. Acute renal failure is
precipitated by myoglobinuria in the
setting of dehydration and aciduria;
therefore, alkalinization of the urine
with sodium bicarbonate often helps
to excrete myoglobin and prevent
further kidney damage.12,15,16
In 2004, the Food and Drug Ad-
ministration (FDA) banned the sale
of ephedra-containing products.17
However, the mere avoidance of sup-
plements with this particular ingredi-
ent has not necessarily made the use of
nutritional supplements safer. At least
two case reports have described the
development of rhabdomyolysis with
the use of performance-enhancing
and weight-loss nutritional supple-
ments that did not contain ephedra,
creatine, or large doses of caffeine.3,18
We report a case of a young adult
man who developed rhabdomyolysis
after ingestion of Hydroxycut (Iovate
Health Sciences U.S.A. Inc., Blasdell,
NY). Hydroxycut, claimed by its
manufacturer to be America’s best-
selling weight-loss product, is avail-
able in four formulations including
Hydroxycut 24 AM, Hydroxycut 24
PM, Hydroxycut Weight-Loss For-
mula, and Hydroxycut Hardcore.19,20
These products do not contain cre-
atine, ephedra, or a large amount of
caffeine. However, the ingredients
may contribute to the development
of rhabdomyolysis.
Case report
An 18-year-old Caucasian man
arrived at an urgent care center
complaining of bilateral leg pain and
weakness. His CK concentration was
elevated (13,220 IU/L; normal range,
case report  Hydroxycut
25–260 IU/L), and serum creati-
nine (SCr) and blood urea nitrogen
(BUN) concentrations were within
normal limits (1.1 and 14 mg/dL, re-
spectively [normal SCr range, 0.6–1.3
mg/dL, normal BUN range, 8–20 mg/
dL]). The patient was diagnosed with
rhabdomyolysis and was instructed to
go to the emergency room (ER). He
went immediately to the ER with the
same complaint of calf tenderness.
His leg tenderness worsened the day
before hospital admission and made
normal activities, such as walking,
incredibly painful. He also admitted
to decreased urine output for four to
five days before admission. He had
no significant past medical history,
and his family history was significant
for hypertension, coronary artery
disease, cerebrovascular accident,
and aneurysm. According to the pa-
tient, he had no drug allergies, and
his current medications included the
following: Hydroxycut one caplet in
the morning, one caplet midday, and
two caplets in the evening, which was
within the dosage range per package
instructions19; naproxen sodium 220
mg by mouth as needed for pain;
dextroamphetamine saccharate–
amphetamine salts (Adderall) 15
mg (one tablet) by mouth five days
prior for a school examination; and
hydrocodone–acetaminophen and
cyclobenzaprine for pain. His social
history revealed an increase in his
daily running mileage and weight
training during the week before ad-
mission. His last alcoholic beverage
was consumed five days prior, and he
was pledging a local fraternity.
On arrival at the ER, his vital
signs were within normal limits
and significant laboratory values
included elevated concentrations of
CK (12,795 IU/L), SCr (1.4 mg/dL),
aspartate transaminase (AST) (586
IU/L; normal range, 12–38 IU/L), al-
anine transaminase (ALT) (173 IU/L;
normal range, 10–45 IU/L), and alka-
line phosphatase (131 IU/L; normal
range, 25–100 IU/L). His BUN (16
mg/dL) and troponin I (negative:
Am J Health-Syst Pharm—Vol 66 Jan 15, 2009
<0.06 ng/mL) levels were within
normal limits. All other liver func-
tion test results and electrolyte values
were within normal limits. Physical
examination revealed bilateral lower-
extremity tenderness to palpation
without any detectable edema. The
patient was diagnosed with rhab-
domyolysis and immediately given
i.v. 0.9% sodium chloride injection.
All of the medications he was taking
before admission were discontinued.
He was admitted to the inpatient
ward. The admitting team ordered
a urinalysis, which was negative for
myoglobin, and a urine drug screen,
which was positive only for opiates.
The negative urine myoglobin did
not rule out rhabdomyolysis because
of the low sensitivity of the urinalysis
test and the team’s strong suspicion
of rhabdomyolysis.20
The patient was continued on
i.v. 0.9% sodium chloride injection.
Heparin 5000 mg was administered
subcutaneously three times daily for
deep venous thrombosis prophylaxis
secondary to the patient’s reduced
mobility. The patient did not require
pain medications. His rhabdomyoly-
sis treatment included a total of 6 L
of 0.9% sodium chloride injection
given intravenously. Serial labora-
tory test values were obtained (Table
1). During his overnight hospital
stay, the patient’s leg tenderness de-
creased, and he was discharged with
instructions to discontinue Hydroxy-
cut, increase fluid intake, avoid alco-
hol consumption, and limit physical
activity for the next week. Two weeks
after hospital discharge, the patient’s
CK and liver enzyme levels returned
to normal, excluding his ALT and
SCr values, which remained slightly
elevated, and his lower-extremity
tenderness fully resolved.
Discussion
A literature search was performed
using PubMed and MEDLINE for
articles in English using the search
terms “rhabdomyolysis” and “nu-
tritional supplements.” Cases of
143
 case report  Hydroxycut

ingredients that reportedly improve

Table 1.
satiety and exercise performance.25
Pertinent Laboratory Test Values for Patient Diagnosed With Garcinia has been postulated to sup-
Rhabdomyolysisa press food intake and inhibit fatty
Day 1 Day 2 Day 17 acid synthesis.25,28,29 Gymnema spe-
Parameter 2:00 p.m. 6:00 p.m. 2:00 a.m. 9:00 a.m. 9:00 p.m. 8:00 a.m. cies are primarily known for their ef-
CK (IU/L) 13,220 12,795 8,050 6,235 5,610 86 fects on glucose utilization, including
AST (IU/L) NR 586 392 NR 358 37 reduced intestinal glucose absorp-
ALT (IU/L) NR 173 134 NR 151 46 tion and increased pancreatic b-cell
SCr (mg/dL) 1.1 1.4 1.2 1.3 1.2 1.4 function.25,30 Soy phospholipids, also
a
CK = creatine kinase, AST = aspartate transaminase, NR = not recorded, ALT = alanine transaminase, SCr = known as lecithin, may produce a
serum creatinine.
feeling of abdominal fullness, but lit-
tle information is available on its role
rhabdomyolysis that may have been days before the onset of pain, she in weight loss.25 Rhodiola rosea may
precipitated by the ingestion of nu- had added two new nutritional improve athletic performance by pro-
tritional supplements containing supplements containing chromium longing the time to exhaustion and
ephedra, creatine, or large amounts picolinate to her complex nutritional improving pulmonary ventilation
of caffeine have been described in supplement regimen that already through its stimulant, antioxidant,
the literature (Table 2).3-11 Manufac- contained ephedrine and several and antistressor effects.25 Withania
turers of performance-enhancing other dietary supplements. She had species have been used for numerous
and weight-loss supplements are taken this regimen for 45 days be- ailments, but little scientific evidence
beginning to avoid these ingredients fore adding the two new products is available to support their use. Their
to improve safety; however, we do and had been on a stable diet and mechanisms in improved exercise
not believe that this will increase the exercise routine. The authors attrib- performance and weight loss may
safety of nutritional supplements. uted her development of rhabdomy- include stimulation of respiratory
Two case reports have described the olysis to the addition of chromium function, antioxidant, and antistres-
use of nutritional supplements that picolinate-containing products rather sor effects.25,31 HydroxyTea is avail-
do not contain ephedra, creatine, and than ephedrine. She was discharged able with and without caffeine. Green
large amounts of caffeine that result- on day 4 with a CK concentration of tea, white tea, and oolong tea may
ed in rhabdomyolysis. The first case 9,952 IU/L. help reduce body weight through
involved a 29-year-old healthy man The nutritional supplement Hy- the action of catechins. Catechins
on a stable physical training regi- droxycut has been associated with are postulated to increase fat and
men who developed rhabdomyolysis seizures and acute liver injury, 22,23 calorie metabolism and appetite sup-
after taking a nutritional supplement but it has not been known to cause pression, with additive effects when
containing glutamine, amino acids, rhabdomyolysis. In addition, seizures caffeine is in the formulation.25,32
electrolytes, and ribonucleic acid for were reported with its prior formula- Caffeine has many metabolic effects
seven days.3 He had diffuse myalgias, tion, which contained ephedra.23 Us- which may contribute to weight
greatest in his lower extremities, and ing the Naranjo et al.24 adverse-effect loss and performance improvement,
a CK concentration of >4,000 IU/L. probability scale, the rhabdomyolysis including increased resting energy
He was treated with aggressive hydra- in our patient was possibly associated expenditure, lipid oxidation, and cel-
tion, resulting in complete resolution with his use of Hydroxycut (Naranjo lular thermogenesis.33,34
of symptoms and normalization of score = 4). The Hydroxycut 24 and Hydroxycut Hardcore contains
his CK level. Weight-Loss Formulas contain calci- the patented formulas of Pyroxyclene
The second case of rhabdomy- um, chromium, and potassium salts fat-loss blend, Norepidrol intensity-
olysis was more complex. Martin and the patented formulas Hydroxa- focus blend, Lasidrate delivery blend,
and Fuller18 described the case of a gen Plus and HydroxyTea (Table 3). and Yohimbacore blend (Table 3).
24-year-old woman who had diffuse Calcium is thought to inhibit lipo- The ingredients are touted to pro-
muscle weakness, pain, bilateral leg genesis and promote lipolysis and duce weight loss, but relatively less is
cramping, and a CK concentration fat loss.25,26 Chromium is believed known about the products in these
exceeding 22,000 IU/L. She was di- to activate the sympathetic nervous preparations compared with other
agnosed with rhabdomyolysis and system, stimulate thermogenesis, Hydroxycut preparations. Cissus
treated with fluids and pain medica- and suppress appetite, possibly at- quadrangularis extract has anti-
tions (cyclobenzaprine, ibuprofen, tributable to its effects on insulin oxidant properties.25,35 White willow
and acetaminophen–codeine). Two levels.25,27 Hydroxagen Plus contains extract has antiinflammatory prop-

144 Am J Health-Syst Pharm—Vol 66 Jan 15, 2009

 case report  Hydroxycut

Table 2.
Case Reports of Rhabdomyolysis Associated With Ephedra, Creatine, or Large Amounts of Caffeinea
Ref. Patient(s) Major ingredient(s) Signs and Symptoms Treatment and Outcome
3 23-yr-old man with Ephedra, guarana, caffeine, Abdominal pain, myalgia, CK Hydration; resolution
stable exercise Garcinia cambogia, concentration = 56,600 IU/L of symptoms and
regimen chromium picolinate, normalization of CK level
l-carnitine, potassium,
magnesium
4 Patient 1: 27-yr-old man Creatine, ephedrine, amino Generalized muscle weakness, Hydration, urinary
with recent extreme acids dehydration, acute renal failure, alkalinization, hyperbaric
exercise regimen CK concentration = 83,634 IU/L oxygen therapy; full
recovery with normal renal
function
Patient 2: 27-yr-old man Myalgia, dark urine, decreased CVVH, fasciotomy, hyperbaric
with recent extreme urine output, renal failure, CK oxygen therapy; recovered
exercise regimen concentration = 114,900 IU/L renal function
Patient 3: 28-yr-old Severe lower-extremity muscle CVVH, fasciotomy, hyperbaric
man with extreme pain, dark urine, dehydration, oxygen therapy; full
exercise regimen renal failure, CK concentration recovery with normal renal
> 200,000 IU/L function
5 54-yr-old obese woman Ephedrine, chromium, Severe spasmodic chest pain, mild Therapy for rhabdomyolysis
without strenuous guarana, Gymnema shortness of breath, no renal not discussed; full recovery
physical activity sylvestre, Garcinia impairment, CK concentration = with normal CK level
cambogia 1,028 IU/L
6 21-yr-old man with Ephedrine, caffeine, Profound muscle weakness, Hydration, urinary
recently increased guarana hypotension, tachycardia, acute alkalinization; full recovery
physical exercise renal failure, CK concentration = with normal renal function
regimen 426 IU/L
7 24-yr-old male Creatine 25 g/day Severe bilateral thigh pain, gross Hydration, urinary
bodybuilder with hematuria, acute renal failure, CK alkalinization, fasciotomy;
stable exercise concentration = 131,000 IU/L rhabdomyolysis and
regimen renal failure resolved and
patient recovered majority
of muscle strength with
physical therapy
8 21-yr-old man Creatine 10 g/day Postsurgical complaints of severe Hydration (with bicarbonate),
undergoing knee pain, foot numbness, mannitol, antihypertensive
arthroscopic knee amber urine, renal failure, CK and pain medications; full
surgery concentration = 167,840 IU/L recovery
9 22-yr-old male High-dose creatine (80 g/ Bilateral lower-extremity pain Hydration, fasciotomy;
bodybuilder with day) and cramping, dark urine, CK recovery not discussed
recent 50% increase concentration = 39,900 IU/L
in physical exercise
regimen
10 36-yr-old man with Caffeine (up to 3 g/day) Disoriented, diaphoretic, delirious, Hydration, hemodialysis; full
schizophrenia who hyponatremia, hematuria, renal recovery
ingested up to 15 L/ dysfunction, CK concentration =
day of oolong tea 200,120 IU/L
(caffeine, 20 mg/dL)
11 21-yr-old man who Caffeine 3.57 g Sought medical attention 5 days Hydration, peritoneal dialysis;
attempted suicide after acute ingestion with recovery unknown
with caffeine restlessness, muscle twitching,
palpitations, vomiting,
decreased urine output, CK
concentration = 1,134 IU/L
a
CK = creatine kinase, CVVH = continuous venovenous hemofiltration.

Am J Health-Syst Pharm—Vol 66 Jan 15, 2009 145

 case report  Hydroxycut
Table 3.
List of Ingredients in Hydroxycut Products
Hydroxycut 24 AM,a
Hydroxycut 24 PM,
Hydroxycut Weight-Loss
Formula
Calcium hydroxycitrate 156 mg
Chromium polynicotinate 133 mg
Potassium hydroxycitrate 218 mg
Hydroxagen Plusb
  Garcinia cambogia extract
  Gymnema sylvestre extract
  Soy phospholipids
  Rhodiola rosea extract
  Withania somnifera extract
HydroxyTeaCFb
  Green tea extract
  White tea extract
  Oolong tea extract
Hydroxycut 24 AM contains HydroxyTea which also contains caffeine.
a amount previously associated with
Patented formula contained within the Hydroxycut product.
b
erties and in combination with stim-
ulants, such as ephedra or cola nut,
has been shown to produce weight
loss due to the inhibition of prosta-
glandins and subsequent increase in
norepinephrine release.36,37 Deanol
bitartrate may improve athletic
performance by increasing oxygen
consumption via enhanced acetyl-
choline formation when combined
with ginseng and other nutritional
supplements. 25,38 Evodia’s role in
treating obesity may be due to its ac-
tion on the vanilloid receptors, which
alters thermogenesis.25,39 Codonopsis
has been suggested to produce weight
loss and increase exercise endurance
through central nervous system stim-
ulation.40 Black pepper may cause
stimulation of thermal receptors and
lipolytic activity.25
With the limited known informa-
tion, it is hard to determine which
particular component of Hydroxycut
could cause rhabdomyolysis. Hy-
146 Am J Health-Syst Pharm—Vol 66 Jan 15, 2009
19,20
Hydroxycut Hardcore
Pyroxyclene fat-loss blendb
  Green tea extract
  Caffeine anhydrous
  Cissus quadrangularis extract
  White willow extract
  Aspidosperma quebracho-blanco extract
Norepidrol intensity-focus blendb
  Deanol bitartrate
  Xanthinol nicotinate
  Evodia rutaecarpa extract
  Inula racemosa extract
  Codonopsis pilosula extract
Lasidrate delivery blendb
  Troxerutin
  Inositol hexaphosphate
  Cnidium monnieri
  Black pepper extract
Yohimbacore blendb
  Methyl 17-alpha-hydroxy-yohimban-16-
  alpha-carboxylate hydrochloride
droxycut and the product described
in the Martin and Fuller18 case both
contain chromium; however, simi-
larities between Hydroxycut and the
product described in the Scroggie
and colleagues3 case are less obvious.
It is also difficult to determine if our
patient’s increased exercise regimen
contributed to the problem. Overex-
ertion and intense physical exercise
have been associated with rhab-
domyolysis; however, some theorize
that neither the amount of exercise
nor the level of training is a reliable
predictor.13,41 Potentially, both Hy-
droxycut and the increased exercise
regimen contributed to the devel-
opment of rhabdomyolysis in this
patient case. This is different from
the cases reported by Scroggie and
colleagues3 and Martin and Fuller,18
whose patients maintained stable
exercise regimens.
The package labeling for Hy-
droxycut includes its indications,
ingredients, directions for use, and a
warning section; adverse effects are
not listed.19,20 This is important be-
cause the adverse effects of the final
Hydroxycut preparation may not
represent the adverse effects of the
individual ingredients due to all of
the potential interactions. The warn-
ing section does state to “discontinue
use and call a medical doctor im-
mediately, if you experience irregu-
lar heartbeat, chest pain, dizziness,
headache, nausea, or other similar
symptoms.” In addition, the package
labeling stresses the importance of
adequate water intake, recommend-
ing “ten 8 oz. glasses of water per
day.”19
Our case report does have some
limitations. First, the patient’s caf-
feine intake was unknown, and the
formulation of Hydroxycut was not
determined. However, the amount
of caffeine supplied by any Hy-
droxycut regimen is below 1 g, the
rhabdomyolysis. Second, our patient
used a nonsteroidal antiinflamma-
tory drug (NSAID) (i.e., naproxen
sodium), and NSAIDs have been
associated with rhabdomyolysis
when combined with strenuous
physical exercise.42 However, these
cases included marathon runners,
some of whom had mild bacterial
and viral infections around the time
of their race. It was concluded that
muscle overexertion with or without
NSAIDS or infection could lead to
rhabdomyolysis. Our patient did
not have evidence of an infection,
and his exercise regimen was not as
strenuous as the regimens previously
reported.42 However, his naproxen
sodium use was not quantified,
which makes it difficult to completely
exclude it as a contributor. Our pa-
tient did admit to alcohol consump-
tion, which has been associated with
rhabdomyolysis in combination
with strenuous exercise.43 However,
the patient in the previous report
consumed enough alcohol to lead
to prolonged unconsciousness. Our

patient reported drinking his last
alcoholic beverage five days before
admission, and there was no report
of unconsciousness, so the contribu-
tion of alcohol to his development of
rhabdomyolysis is likely small. Lastly,
our patient also reported taking a
combination product containing
amphetamines, which are sympath-
omimetic amines that inhibit nor-
epinephrine reuptake.44 The package
insert for the dextroamphetamine–
amphetamine product indicates
that overdosage and idiosyncratic
reactions associated with amphet-
amines may lead to adverse events,
including rhabdomyolysis. To our
knowledge, no case reports involving
dextroamphetamine—amphetamine-
induced rhabdomyolysis have been
published to date. However, the
combination drug could theoretically
have caused vasoconstriction, which
is one of the postulated mechanisms
for ephedrine-induced rhabdomy-
olysis.3,45 The clinical significance of
this finding is likely negligible in our
patient case, since he ingested only
one dose five days before admission.
Despite these limitations, we believe
Hydroxycut contributed, at least in
part, to our patient’s rhabdomyolysis,
so we instructed him to stop taking
the nutritional supplement.
Based on the previous discus-
sion, we believe any performance-
enhancing and weight-loss nutri-
tional supplement could potentially
lead to rhabdomyolysis, especially
if the patients self-prescribing these
products are also participating in an
exercise program. It is essential that
patients understand this risk and
the importance of hydration and
avoidance of other toxic substances,
such as caffeine and alcohol, in or-
der to prevent or detect this serious
adverse event. Because nutritional
supplements are not regulated by
FDA, their package labeling is often
limited. Pharmacists need to be
proactively involved in the care of
these patients by performing com-
prehensive medication histories and
case report  Hydroxycut
education sessions for other health
care professionals. Alternative medi-
cine databases, such as the Natural
Medicines Comprehensive Database,
the Review of Natural Products, and
the Physician’s Desk Reference for
Herbal Medicines, should be used to
review adverse effects and other per-
tinent information about nutritional
supplements. However, limitations,
such as lack of free access, training on
their use, and frequency of informa-
tion updates, limit their usefulness.
Also, final nutritional supplement
products may not represent the sum
of each individual ingredient due
to potential complex interactions
among ingredients.
In the past, FDA’s Center for
Food Safety and Applied Nutrition
(CFSAN) maintained a Special Nu-
tritional Adverse Event Monitoring
System. This website has been re-
moved due to its format and limited
availability of information. The data-
base has been replaced by the CFSAN
Adverse Event Reporting System,
which informs nutritional supple-
ment manufacturers of reported ad-
verse events via a notification letter.46
There are limitations to this, and
the CFSAN is currently working to
improve the availability of adverse-
effect information for consumers and
health care professionals. Until then,
health care professionals, particu-
larly pharmacists, should continue
to report nutritional supplement ad-
verse events. Published case reports
concerning this topic are paramount
to increasing the available current
information.
Conclusion
An 18-year-old Caucasian man
with no significant medical history
developed rhabdomyolysis possibly
associated with the ingestion of Hy-
droxycut in addition to his increased
exercise regimen.
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4. Sandhu RS, Como JJ, Scalea TS et
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