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Because of possible serious drug interactions, it is important to tell your doctor what
other drugs you are taking, including those obtained without a prescription.
ZOCOR® (simvastatin) can interact with cyclosporine (Sandimmune), itraconazole, ketoconazole,
gemfibrozil, niacin, erythromycin, clarithromycin, HIV protease inhibitors, nefazodone, and verapamil. To avoid possible serious side ef ects, avoid drinking large quantities of grapefruit juice (more than one
quart daily) while on ZOCOR. (See WARNINGS, Muscle.)
PLEASE READ THIS SUMMARY CAREFULLY, AND THEN ASK YOUR DOCTOR ABOUT
Some patients taking lipid-lowering agents similar to ZOCOR and coumarin anticoagulants (a type of
ZOCOR. NO ADVERTISEMENT CAN PROVIDE ALL THE INFORMATION NEEDED TO
blood thinner) have experienced bleeding and/or increased blood clotting time. Patients taking these
PRESCRIBE A DRUG. THIS ADVERTISEMENT DOES NOT TAKE THE PLACE OF CARE-
medicines should have their blood tested before starting therapy with ZOCOR and should continue to
FUL DISCUSSIONS WITH YOUR DOCTOR. ONLY YOUR DOCTOR HAS THE TRAINING
TO WEIGH THE RISKS AND BENEFITS OF A PRESCRIPTION DRUG FOR YOU.
Central Nervous System Toxicity; Cancer, Mutations, Impairment of Fertility:
prescription drugs, ZOCOR was required to be tested on animals before it was marketed for human use.
USES OF ZOCOR
Often these tests were designed to achieve higher drug concentrations than humans achieve
at recommended dosing. In some tests, the animals had damage to the nerves in the central nervous
ZOCOR is a prescription drug that is indicated as an addition to diet for many patients with high choles-
system. In studies of mice with high doses of ZOCOR, the likelihood of certain types of cancerous tumors
terol when diet and exercise are inadequate. For patients with coronary heart disease (CHD) and high cho-
increased. No evidence of mutations of or damage to genetic material has been seen. In one study with
lesterol, ZOCOR is indicated as an addition to diet to reduce the risk of death by reducing coronary death;
ZOCOR, there was decreased fertility in male rats.
to reduce the risk of heart attack; to reduce the risk for undergoing cardiac procedures (coronary artery
bypass grafting and percutaneous transluminal coronary angioplasty); and to reduce the risk of stroke or
Pregnant women should not take ZOCOR because it may harm the fetus.
Safety in pregnancy has not been established. In studies with lipid-lowering agents similar to ZOCOR,
WHEN ZOCOR SHOULD NOT BE USED
there have been rare reports of birth defects of the skeleton and digestive system. Therefore, women of
Some people should not take ZOCOR. Discuss this with your doctor.
childbearing age should not take ZOCOR unless it is highly unlikely they will become pregnant. If a
ZOCOR should not be used by patients who are allergic to any of its ingredients. In addition to the active
woman does become pregnant while taking ZOCOR, she should stop taking the drug and talk to her doc-
ingredient simvastatin, each tablet contains the following inactive ingredients: cellulose, lactose, mag-
tor at once. The active ingredient of ZOCOR did not cause birth defects in rats at 3 times the human dose
nesium stearate, iron oxides, talc, titanium dioxide, and starch. Butylated hydroxyanisole is added as a
or in rabbits at 3 times the human dose.
Drugs taken by nursing mothers may be present in their breast milk. Because of the
Patients with liver problems:
ZOCOR should not be used by patients with active liver disease or
potential for serious adverse reactions in nursing infants, a woman taking ZOCOR should not breast-
repeated blood test results indicating possible liver problems. (See WARNINGS.)
feed. (See WHEN ZOCOR SHOULD NOT BE USED.)
Women who are or may become pregnant:
Pregnant women should not take ZOCOR because it
ZOCOR is not recommended for children or patients under 20 years of age.
may harm the fetus. Women of childbearing age should not take ZOCOR unless it is highly
unlikely that they will become pregnant.
If a woman does become pregnant while on ZOCOR, she
Higher blood levels of active drug were seen in elderly patients (70-78 years of age)
should stop taking the drug and talk to her doctor at once.
compared with younger patients (18-30 years of age) in one study. In other studies, the cholesterol-
lowering effects of ZOCOR were at least as great in elderly patients as in younger patients, and there were
Women who are breast-feeding
should not take ZOCOR.
no overall differences in safety between elderly and younger patients over the 20-80 mg/day dosage range.
Muscle: Tell your doctor right away if you experience any unexplained muscle pain,
tenderness, or weakness at any time during treatment with ZOCOR so your doctor can
Most patients tolerate treatment with ZOCOR well; however, like all prescription drugs, ZOCOR can cause
decide if ZOCOR should be stopped. Some patients may have muscle pain or weakness
side effects, and some of them can be serious. Side effects that do occur are usually mild and short-
while taking ZOCOR. Rarely, this can include muscle breakdown resulting in kidney
lived. Only your doctor can weigh the risks versus the benefits of any prescription drug. In clinical stud-
damage. The risk of muscle breakdown is greater in patients taking certain other drugs
ies with ZOCOR, less than 1.5% of patients dropped out of the studies because of side effects. In a large,
along with ZOCOR, such as the lipid-lowering drug Lopid (gemfibrozil), and other fibrates;
long-term study, patients taking ZOCOR experienced similar side effects to those patients taking placebo
lipid-lowering doses of niacin (nicotinic acid); Sandimmune (cyclosporine);
(sugar pills). Some of the side effects that have been reported with ZOCOR or related drugs are listed
itraconazole, ketoconazole, and other azole antifungal drugs; the antibiotics erythromycin
below. This list is not complete. Be sure to ask your doctor about side effects before taking ZOCOR and
and clarithromycin; HIV protease inhibitors; the antidepressant nefazodone; and the cal-
to discuss any side effects that occur.
cium channel blocker verapamil. Interruption of therapy with ZOCOR should be
Constipation, diarrhea, upset stomach, gas, heartburn, stomach pain/cramps,
considered if you are going to take an azole antifungal medication, such as itraconazole,
anorexia, loss of appetite, nausea, inflammation of the pancreas, hepatitis, jaundice, fatty changes in the
or macrolide antibiotics, such as erythromycin. Avoid drinking large quantities of
liver, and, rarely, severe liver damage and failure, cirrhosis, and liver cancer.
grapefruit juice (more than one quart daily) while on ZOCOR. The risk of muscle
breakdown is greater in patients with kidney problems or diabetes.
Muscle cramps, aches, pain, and weakness; joint pain; muscle breakdown.
Because there are risks in combining therapy with ZOCOR with the products listed above,
Dizziness, headache, insomnia, tingling, memory loss, damage to nerves causing
your doctor should carefully weigh the potential benefits and risks. He or she should also
weakness and/or loss of sensation and/or abnormal sensations, anxiety, depression, tremor, loss of
carefully monitor patients for any muscle pain, tenderness, or weakness, particularly
during the initial months of therapy and if the dose of either drug is increased. Your
Rash, itching, hair loss, dryness, nodules, discoloration.
doctor also may monitor the level of certain muscle enzymes in your body, but there is no
assurance that such monitoring will prevent the occurrence of severe muscle disease.
Blurred vision, altered taste sensation, progression of cataracts, eye muscle weakness.
If you have conditions that can increase your risk of muscle breakdown, which in turn
Hypersensitivity (Allergic) Reactions:
On rare occasions, a wide variety of symptoms have been
can cause kidney damage, your doctor should temporarily withhold or stop ZOCOR. Also,
reported to occur either alone or together in groups (referred to as a syndrome) that appeared to be based
since there are no known adverse consequences of briefly stopping therapy with ZOCOR,
on allergic-type reactions, which may rarely be fatal. These have included one or more of the following: a
treatment should be stopped a few days before elective major surgery and when any
severe generalized reaction that may include shortness of breath, wheezing, digestive symptoms, and low
major acute medical or surgical condition occurs. Discuss this with your doctor, who can
blood pressure and even shock; an allergic reaction with swelling of the face, lips, tongue and/or throat with
explain these conditions to you.
difficulty swallowing or breathing; symptoms mimicking lupus (a disorder in which a person’s immune
Liver: About 1% of patients who took ZOCOR in clinical trials developed elevated levels
system may attack parts of his or her own body); severe muscle and blood vessel inflammation, sometimes
of some liver enzymes.
Patients who had these increases usually had no symptoms. Elevated liver
including rash; bruises; various disorders of blood cells (that could result in anemia, infection, or blood
enzymes usually returned to normal levels when therapy with ZOCOR was stopped.
clotting problems) or abnormal blood tests; inflamed or painful joints; hives; fatigue and weakness;
In the ZOCOR Survival Study, the number of patients with more than one liver enzyme level elevation to
sensitivity to sunlight; fever, chills; flushing; difficulty breathing; and severe skin disorders that vary from
greater than 3 times the normal upper limit was no different between the ZOCOR and placebo groups. Only
rash to a serious burn-like shedding of skin all over the body, including mucous membranes such as the
8 patients on ZOCOR and 5 on placebo discontinued therapy due to elevated liver enzyme levels. Patients
were started on 20 mg of ZOCOR, and one third had their dose raised to 40 mg.
Loss of sexual desire, breast enlargement, impotence.
Your doctor should perform routine blood tests to check these enzymes before you start
Liver function test abnormalities including elevated alkaline phosphatase and biliru-
treatment with ZOCOR and periodically thereafter (for example, semiannually) for your
bin; thyroid function abnormalities.
first year of treatment or until 1 year after your last elevation in dose. Patients titrated to
the 80-mg dose should receive an additional test at 3 months.
If your enzyme levels increase,
NOTE: This summary provides important information about ZOCOR. If you would like
your doctor should order more frequent tests. If your liver enzyme levels remain unusually high, your
more information, ask your doctor or pharmacist to let you read the complete prescribing
doctor should discontinue your medication.
information and then discuss it with them.
Tel your doctor about any liver disease you may have had in the past and about how much alcohol you
consume. ZOCOR should be used with caution in patients who consume large amounts of alcohol.
ZOCOR is a registered trademark of Merck & Co., Inc.
The other brands listed are trademarks of their
Before starting treatment with ZOCOR, try to lower your cholesterol by other methods such as diet,
respective owners and not of Merck & Co., Inc.
exercise, and weight loss. Ask your doctor about how best to do this. Any other medical problems that can
cause high cholesterol should also be treated.
2001 Merck & Co., Inc. All rights reserved.
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1 This package insert has warnings all over it. Yet only Dr. Cenaiko concluded that Evans' problems were
caused by ZOCOR and that cholesterol is not dangerous. After Evans discovered Statin drug side effects and pointed them out, all of the other doctors Evans saw refused to accept that ZOCOR could have had anything to do with Evans' medical problems. They stick to their story TO THIS DAY. Ask 'em. This document places responsibility on doctors "report pain . so your doctor can decide if ZOCOR should be stopped." "ONLY YOUR DOCTOR HAS THE TRAINING TO WEIGH THE RISKS AND BENEFITS OF A PRESCRIPTION DRUG FOR YOU." What training would that be? Oh yes, doctors are trained by the pharmaceutical companies. Despite this document, replete with warnings, Alport told Evans in 1992, "There are no side effects." Evans would have stopped taking ZOCOR in a second if he had suspected it was causing his misery. Instead, Evans trusted the doctors and the pharmacists. LIPITOR has the same warnings as ZOCOR because it is the same drug. In the patent medicine racket, they just change one molecule slightly so they can get a new patent. Who has coached doctors to ignore side effects? Could it be the pharmaceutical companies who make billions of dollars every year selling dangerous products of dubious value through doctors? Very likely.
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