Full text of DOI:10.1592/phco.22.7.533.33674

Cerivastatin-Induced Rhabdomyolysis: 11 Case Reports
Susan L. Ravnan, Pharm.D., Christy Locke, Pharm.D., William P. Yee, Pharm.D., and
Kelli Haase, Pharm.D.
3
-Hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors
are a frequently prescribed class of drugs that are generally well tolerated by
most patients. A rare, yet serious side effect associated with these drugs is
rhabdomyolysis. Although all HMG-CoA reductase inhibitors can cause this
adverse effect, prevalence may differ among specific agents. Over a 16-month
period, in three hospitals, 11 patients experienced cerivastatin-induced
rhabdomyolysis, but no cases of rhabdomyolysis associated with any other
HMG-CoA reductase inhibitors were reported.
(
Pharmacotherapy 2002;22(4):533–537)
Coronary artery disease is associated with
with an increase in creatine kinase more than 10
times the upper limit of normal. Rhabdomyolysis,
8
5
00,000 deaths and over 2 million hospital-
1
izations annually in the United States. Lowering
plasma lipid levels has become a major area of
emphasis in treatment and prevention of
coronary artery disease. 3-Hydroxy-3-methyl-
glutaryl coenzyme A (HMG-CoA) reductase
inhibitors (statins) decrease cardiovascular
on the other hand, has been defined by smaller
increases in creatine kinase (≥ 5 times the upper
limit of normal), and severe myopathy and
rhabdomyolysis have been defined by a creatine
9
, 10
kinase level of more than 10,000 U/L.
One
difference between myopathy and rhabdomyolysis
may be presence of myoglobinuria or dark
2
–4
morbidity and mortality.
Current practices in
1
1–14
cardiovascular medicine stress aggressive lipid
management, and statins are considered first-line
urine.
Not all definitions of rhabdomyolysis
include myoglobinuria, which suggests that the
amount of myoglobin released, glomerular
filtration rate, and urine concentration may affect
5
therapy for many lipid disorders. Unfortunately,
statin monotherapy may not always achieve both
target low-density lipoprotein cholesterol and
triglyceride levels in mixed hyperlipidemias.
Augmentation with a fibric acid derivative (e.g.,
gemfibrozil) is often necessary to enhance lipid-
9
detection of myoglobin.
Initial clinical trials demonstrated that
combination statin-fibrate therapy is effective and
1
5, 16
does not increase the risk of rhabdomyolysis.
6
lowering activity and reach lipid therapy goals.
However, case reports documenting occurrences
of rhabdomyolysis in patients receiving combination
statin-fibrate therapy suggest that the rate of
rhabdomyolysis may be greater than first stated
Adverse reactions associated with statins
include elevations in serum transaminases (> 3
times the upper limit of normal), myalgia, muscle
7
13,
weakness, myopathy, and rhabdomyolysis.
and may be different for specific statin agents.
1
4, 17–23
Although quite low, the precise percentage of
patients who develop myopathy rather than
rhabdomyolysis is difficult to establish because of
conflicting definitions. Myopathy has been
defined as muscle aching or weakness associated
From the University of the Pacific Thomas J. Long School
of Pharmacy and Health Sciences (Dr. Ravnan), and St.
Joseph ’s Medical Center (Drs. Locke, Yee, and Haase),
Stockton, California.
One study reported an increased frequency
of myopathy or rhabdomyolysis in patients
receiving gemfibrozil-lovastatin therapy versus
10
gemfibrozil alone. Although rhabdomyolysis may
be associated with gemfibrozil alone, this effect
2
4, 25
has not been observed in large clinical trials.
Because of the seriousness of rhabdomyolysis
and the number of case reports documenting this
effect, manufacturers have provided a warning
against combination therapy with statins and
Address reprint requests to Susan L. Ravnan, 3601 Pacific
Avenue, Stockton, CA 95211; e-mail: sravnan@chw.edu.

5
34
PHARMACOTHERAPY Volume 22, Number 4, 2002
Table 1. Patient Demographics
Table 2. Concomitant Medical Conditions That Could
Increase Risk of Rhabdomyolysis
Body Mass
Index
(kg/m )
Age (yrs)/
Gender
Height
(in.)
Weight
(kg)
History of
Diabetes
Mellitus
History
of Hepatic
Impairment
History
of Renal
Impairment
Surgery or
Trauma < 30
Days Earlier
2
7
7
7
6
6
7
5
6
5
5
7
4/F
60.5
71.0
59.5
62.0
70.5
57.5
67.0
66.0
63.0
68.0
59.0
53.8
107.9
97.3
76.9
106.4
49.3
78.0
54.0
61.0
97.0
53.0
22.2
33.2
31.2
31.0
33.2
23.1
26.9
19.2
23.8
32.5
23.6
4/M
2/M
5/F
3/M
5/F
9/M
8/M
5/F
9/M
5/F
No
No
Yes
No
No
No
Yes
Yes
No
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
Information obtained from patients’ medical records.
Table 3. Selected Laboratory Test Results
Serum
Serum
Creatinine Myoglobin
(mg/dl)
Urine
Change
Maximum
Maximum
AST
(U/L)
Maximum
ALT
(U/L)
Albumin
BUN
(g/dl)
in Urine Creatine Kinase
Impaired
Ambulation
a
a
a
a
(
g/dl)
(µg/L)
Color
(U/L)
3
.2
.6
75
76
75
99
18
104
40
81
129
17
14
5.3
8.7
4.1
6.2
1.3
5.8
1.9
3.5
8.3
0.7
2.3
197,000
5550
55,800
NA
NA
NA
> 150,000
NA
NA
215,000
NA
NA
Yes
Yes
Yes
Yes
Yes
Yes
Yes
NA
NA
NA
46,923
95,711
65,102
348,000
71,460
75,600
180,160
12,685
257,373
36,606
7,768
687
1387
1219
2183
1696
NA
1579
609
461
NA
363
782
1075
640
NA
777
638
240
302
95
Yes
Yes
Yes
Yes
Yes
Yes
NA
NA
NA
Yes
Yes
2
3
3
3
2
1
3
3
4
2
.6
.9
.8
.9
.9
.7
797
153
.9
BUN = blood urea nitrogen; AST = aspartate aminotransferase; ALT = alanine aminotransferase; NA = not available.
a
At admission to hospital.
gemfibrozil. Bayer Pharmaceutical, the manu-
facturer of cerivastatin, classified the cerivastatin-
gemfibrozil combination as a contraindication
conditions that could increase the risk of
rhabdomyolysis, and selected laboratory results
are shown in Tables 1–3, respectively. Admitting
physicians diagnosed each of the 11 patients with
rhabdomyolysis. All patients complained of
severe leg pain; ambulation was impaired in eight
patients after cerivastatin therapy was begun.
Urine was positive for myoglobin in five patients;
three of them also had urine that appeared
bloody, burgundy, or dark. In four other patients,
whose urine myoglobin levels were not obtained,
urine changed color. In two patients, neither
color change in urine nor myoglobinuria was
reported; therefore, their condition may be
classified by some as myopathy rather than
rhabdomyolysis.
8
and subsequently removed cerivastatin from the
market because of the many reports of
2
6
rhabdomyolysis and associated fatalities.
Methods
During a 16-month period, 11 patients were
hospitalized and diagnosed with rhabdomyolysis
at our three hospitals (St. Joseph ’s Medical
Center, six patients; Dameron Hospital, one
patient; San Joaquin General Hospital, four
patients). All cases were reviewed by a pharmacist
to confirm the etiology of rhabdomyolysis, and
all were assessed using the validated Naranjo
Mean age of the 11 patients was 67.2 years; 5
were women. Mean body mass index was 25.2
2
7
adverse drug reaction probability scale.
2
2
kg/m (normal range 18.5–24.9 kg/m ). Most
patients had no predisposing disease states,
although five had a history of diabetes mellitus.
Summary of Case Reports
Patient demographics, concomitant medical

CERIVASTATIN-INDUCED RHABDOMYOLYSIS Ravnan et al
535
2
7
Table 4. Drug History, Concurrent Therapy, and Scores on Naranjo Adverse Drug Reaction Probability Scale
Naranjo
a
Lipid Management History (before hospital admission)
Cerivastatin 0.4 mg x 30 days
Concurrent Therapy
Captopril, aspirin, felodipine, atenolol
chlorthalidone
Score
7
Niacin 1 g/day (long term), cerivastatin 0.8 mg h.s x 28 days
Naproxen, atenolol
7
4
4
Gemfibrozil 600 mg b.i.d (long term), cerivastatin 0.4 mg h.s. x 1 wk
Enalapril, hydrochlorothiazide-triamterene
Atorvastatin x 3 years, gemfibrozil 600 mg b.i.d. x 1 year,
cholestyramine x 33 days, atorvastatin changed to
cerivastatin 0.8 mg h.s. x 33 days
Naproxen, propoxyphene,
hydrocodone-acetaminophen
Simvastatin x 2 years, changed to cerivastatin 0.4 mg h.s. x 2 mo,
gemfibrozil 600 mg b.i.d. x 21 days
Fosinopril, aspirin, amiodarone,
furosemide
4
Pravastatin x 4 mo, changed to cerivastatin 0.4 mg h.s. x 14 mo
Etodolac, aspirin, levothyroxine
7
7
Fluvastatin 40 mg h.s., changed to cerivastatin x 24 days,
gemfibrozil 600 mg b.i.d. x 28 days
Felodipine, verapamil, aspirin, insulin
Cerivastatin 0.4 mg h.s. x 29 days
Benazepril, clopidogrel, atenolol, aspirin
7
7
Fluvastatin (long term), changed to cerivastatin 0.4 mg h.s. x 9 mo
Benazepril, amitriptyline, nitroglycerin,
hydrochlorothiazide-triamterene,
clopidogrel
Cerivastatin 0.8 mg h.s. + gemfibrozil 600 mg b.i.d
Amlodipine, glyburide, cyclobenzaprine,
tramadol
4
4
Cerivastatin 0.4 mg h.s. x 30 days, gemfibrozil 600 mg b.i.d. x 14 days
Nifedipine, atenolol, aspirin, glipizide
a
Adverse events are defined as ≥ 9 = definite, 5–8 = probable, 1–4 = possible, and ≤ 0 = doubtful.
All patients had elevated creatine kinase levels,
with maximum levels of 7768–348,000 U/L. Six
patients had serum albumin levels below 3.5 g/dl
production of coenzyme Q and heme A. The
second suggests that statins inhibit intracellular
cholesterol, leading to alterations in muscle cell
7
(
normal range 3.5–5.0 g/dl).
Complete lipid management history, concurrent
membrane formation.
The exact mechanism causing increased
skeletal muscle damage with the gemfibrozil-
statin combination is uncertain; hypotheses have
been made for both pharmacokinetic and
drugs, and scores on the Naranjo adverse drug
2
7
reaction probability scale are shown in Table 4.
Six of the 11 patients were taking gemfibrozil
with cerivastatin for hyperlipidemic management,
and one was taking niacin with cerivastatin.
Four were taking cerivastatin alone. Four
patients whose conditions had been stabilized
with another statin developed rhabdomyolysis
after conversion to cerivastatin as mandated by
their health maintenance organizations.
2
8–31
pharmacodynamic interactions.
A study that
assessed the pharmacokinetic interaction
between simvastatin and gemfibrozil concluded
that both maximum concentration and area
under the curve for simvastatin acid were
increased when gemfibrozil was combined with
28
simvastatin. The authors speculated that the
Management of rhabdomyolysis involved
discontinuation of all lipid-management drugs,
hydration, and urinary alkalinization; seven
patients required inpatient hemodialysis. In six
patients, symptoms resolved after treatment, with
no permanent disability. One patient died. Four
patients still were lost to follow-up.
pharmacokinetic interaction involved inhibition
of a pathway not mediated by cytochrome P450
3
A4. Similarly, a 4-fold increase in systemic
exposure and elimination half-life of cerivastatin
was observed when combined with gemfibrozil,
indicating a pronounced pharmacokinetic
32
interaction.
Several risk factors have been associated with
elevated statin concentrations that may increase
the risk of rhabdomyolysis. Elevated statin
concentrations may occur in women older than
65 years with low body weight, patients with
renal or hepatic dysfunction, and patients with
Discussion
The mechanism of statin-induced rhabdomyolysis
has not been clearly determined. Two theories
involving different mechanisms of cell lysis and
death exist. One involves decreased production
of adenosine triphosphate, leading to reduced
1
3, 15, 18, 20, 33
low serum albumin levels.
In addition,

5
36
PHARMACOTHERAPY Volume 22, Number 4, 2002
higher statin dosages or concurrent adminis-
tration with an interacting drug may increase
statin concentrations, predisposing patients to
that could lead to excessive cerivastatin
concentrations. One patient was a small, elderly
woman. Two patients were taking the maximum
dosage of cerivastatin plus either niacin or
gemfibrozil; these agents are known to increase
the risk of statin-induced myopathy, although the
interaction of cerivastatin with niacin needs to be
8
, 34–36
myotoxic reactions.
Pharmacokinetic differences among statins
may potentiate risk of elevated statin levels and
toxicity. Cerivastatin is more than 99% protein
bound, which may lead to increased cerivastatin
levels in patients with hypoalbuminemia.
Atorvastatin, fluvastatin, lovastatin, and
simvastatin levels also may be increased in
patients with hypoalbuminemia due to their high
degree of protein binding. In contrast,
pravastatin is roughly 50% protein bound and
3
8
elucidated. Other factors also could lead to
increased statin levels. Three patients had a
history of renal insufficiency; however, renal
insufficiency was not clearly defined. Of the 11
patients, 10 were taking a nonsteroidal anti-
inflammatory agent, an angiotensin-converting
enzyme inhibitor, or both. This combination
could lead to decreased renal function and
subsequent accumulation of cerivastatin. Six
patients had low albumin levels. This is of
interest because low serum albumin may cause
transient increases in serum drug concentration,
8, 37, 38
may not pose the same risk.
Coadministration
with drugs metabolized by pathways similar to
those of the statins may elevate statin concen-
trations, leading to increased adverse events. In
addition, highly lipophilic agents such as
cerivastatin, atorvastatin, simvastatin, and
lovastatin may be more toxic to muscle cells than
3
3
possibly increasing the risk of toxicity. Clinical
significance of this effect remains to be
determined.
3
9
hydrophilic statins. Further information on
pharmacologic properties of individual statins
Although cerivastatin has been removed from
the market, the risk of rhabdomyolysis associated
with other statins remains. It may appear that a
higher frequency of rhabdomyolysis was
associated with cerivastatin than other statins,
but this is difficult to establish. To determine the
precise frequency of rhabdomyolysis, the number
of adverse events should be compared with the
number of patients taking the drug; this
information was not readily available. In
addition, the distinction between rhabdomyolysis
and myopathy must be made. Clearly, one statin
is not appropriate for all patients, and individual
treatment is necessary. Unfortunately, not all
prescribers have the luxury of selecting the most
appropriate statin for each of their patients
because of the restricted drug formularies of
health maintenance organizations and hospitals.
To minimize possible development of rhabdo-
myolysis with the remaining statins, we suggest
carefully evaluating each patient’s risk of
increased statin concentrations and selecting
statins individually by focusing on pharmaco-
kinetic and pharmacodynamic differences among
all agents.
4
0, 41
has been published.
Data from the public citizen petition to the
Food and Drug Administration (FDA) reported
that from October 1997–December 2000, 772
cases of statin-induced rhabdomyolysis were
reported to the FDA adverse event reporting
system; cerivastatin accounted for 50.1% of
4
2
them. Combination therapy with gemfibrozil
and cerivastatin accounted for a little over half of
those cases. Rhabdomyolysis has been associated
with all of the currently marketed statins;
however, the frequency was lower than with
cerivastatin. In less than 20% of cases involving
other statins, combination therapy with gemfibrozil
was implicated.
Conclusion
We observed 11 patients with cerivastatin-
associated rhabdomyolysis during a relatively
brief time. No patients with rhabdomyolysis
secondary to any other statin were admitted to
these hospitals during this time. It is unfortunate
that many of our cases, like those reported to the
FDA adverse event reporting system, involved
gemfibrozil, a drug known to have negative
effects when combined with cerivastatin. A
telephone survey of area pharmacists revealed that
many pharmacy computer systems did not recognize
the cerivastatin-gemfibrozil contraindication.
In addition to drug interactions with gemfibrozil
and niacin, all 11 of the patients had risk factors
Acknowledgments
The authors acknowledge Andrea Hinton, Pharm.D.,
and David Curtis, Pharm.D., for help with data collection.
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