Important Safety Information
LIPITOR is indicated to reduce the risk of myocardial infarction (MI), revascularization
procedures, angina, and stroke in adult patients with multiple risk factors but
without clinically evident coronary heart disease (CHD); to reduce the risk of MI
and stroke in patients with type 2 diabetes and without clinically evident CHD,
but with multiple risk factors; to reduce the risk of nonfatal MI, fatal and nonfatal
stroke, revascularization procedures, hospitalization for congestive heart failure
(CHF), and angina in adult patients with clinically evident CHD.
LIPITOR, as an adjunct to diet, is also indicated to reduce elevated TC, LDL-C,
apo B, and TG levels; and to increase HDL-C in patients with primary hypercholesterolemia
(heterozygous familial and nonfamilial) and mixed dyslipidemia.
LIPITOR is contraindicated in patients with active liver disease or unexplained
persistent elevations of serum transaminases; in women who are or may become pregnant
or who are nursing; in patients with hypersensitivity to any component of this medication.
Rare cases of rhabdomyolysis have been reported with LIPITOR and other statins.
With any statin, tell patients to promptly report muscle pain, tenderness, or weakness.
Discontinue drug if myopathy is suspected, if creatine phosphokinase (CPK) levels
rise markedly, or if the patient has risk factors for rhabdomyolysis.
Due to increased risk of myopathy seen with LIPITOR and other statins, lower starting
doses of LIPITOR should be considered when administered concomitantly with cyclosporine,
fibric acid derivatives, erythromycin, clarithromycin, ritonavir/saquinavir, ritonavir/lopinavir,
immunosuppressive drugs, azole antifungals, or niacin; and physicians should carefully
monitor patients for signs or symptoms of myopathy early during therapy and when
titrating dose of either drug.
It is recommended that liver function tests be performed prior to and 12 weeks following
both the initiation of therapy and any elevation of dose, and periodically thereafter.
If ALT or AST values >3 x ULN persist, dose reduction or withdrawal is recommended.
In a post hoc analysis of the SPARCL study in 4731 patients without CHD who had
a stroke or TIA within the preceding 6 months, a higher incidence of hemorrhagic
stroke was seen in the LIPITOR 80-mg group compared with placebo. Patients with
hemorrhagic stroke on study entry appeared to be at increased risk of hemorrhagic
stroke.
In clinical trials, the most common adverse events were constipation, flatulence,
dyspepsia, and abdominal pain.