|
Crestor may cause low platelet count (may cause bleeding problems). This drug may also cause the following symptoms that are related to low platelet count: Medical Source InformationYellow highlights indicate symptoms related to low platelet count. Hematologic side effects including anemia and ecchymosis have been reported. Hematologic side effects including hemolytic anemia, thrombocytopenia, thrombotic thrombocytopenic purpura (TTP), and leukopenia have occurred with HMG-CoA reductase inhibitors. These effects may be manifestations of a hypersensitivity reaction. Rosuvastatin is contraindicated in women who are or may become pregnant. By reducing cholesterol synthesis, rosuvastatin may cause fetal harm when administered to a pregnant woman. In addition, the benefit of treatment during pregnancy is unclear and the safety in pregnant women is unknown. The risks to the fetus and the lack of known clinical benefit during pregnancy should be explained to patients if they become pregnant while taking rosuvastatin.
Dipstick-positive proteinuria and microscopic hematuria have been seen with HMG-CoA use, more frequently in patients taking 40 mg of rosuvastatin. These findings were usually temporary and not associated with worsening renal function. While the clinical significance is unknown, a dose reduction should be considered for patients on rosuvastatin with unexplained persistent proteinuria and/or hematuria during routine urinalysis testing.
Caution should be exercised when anticoagulants are given in conjunction with rosuvastatin because of its potentiation of the effect of coumarin-type anticoagulants in prolonging the prothrombin time/INR. In patients taking coumarin anticoagulants and rosuvastatin concomitantly, INR should be determined before starting rosuvastatin and frequently enough during early therapy to ensure that no significant alteration of INR occurs.
Renal side effects including various forms of renal failure have been reported in patients taking rosuvastatin, although causality has not been determined. Patients who are candidates for statin therapy (e.g., patients with diabetes, hypertension, atherosclerosis, and/or heart failure) may also be at higher risk for kidney failure even when they are not taking statins.
Proteinuria with or without hematuria has been reported during rosuvastatin therapy, and appears to be dose related. Side Effects to Watch Watch closely for the following side effects and notify your physician immediately should any of these develop: - Abnormal bruising or signs of bleeding such as bleeding from the gums, nose, digestive tract, vagina (females), faintness, dizziness, loss of consciousness, or rash (signs of problems with blood clot formation)
- Muscle pain, weakness or tenderness (signs of a serious condition called "myopathy" in which muscle damage occurs)
Lab and Diagnostic Tests If certain symptoms develop, ask your physician whether you need the following lab tests or other diagnostic tests (if you've not already had them): - liver function tests - check before starting treatment and then periodically
- Creatine kinase - in people who develop muscle pain, weakness, or tenderness
- inr - check before starting treatment
- Blood tests to assess normal clotting - in people who develop signs of bleeding such as abnormal bruising or signs of bleeding including bleeding from the gums, nose, digestive tract, vagina (females), faintness, dizziness, loss of consciousness, or rash
- liver function tests - at start of treatment and then every 6 months
References - Product Information. Crestor (rosuvastatin). Anonymous AstraZeneca Pharma Inc, Mississauga, ON.
- Thrombotic thrombocytopenic purpura associated with statin treatment. Sundram F, Roberts P, Kennedy B, Pavord S Postgrad Med J 2004;80:551-2.
Multum version: 154.0
(Jun 16, 2010)
|
|
|