pravastatin, Pravigard PAC (discontinued) (cont.)

Pharmacy Author:
Medical and Pharmacy Editor:

PREGNANCY: Statins should not be used by pregnant women because they impair fetal development.

NURSING MOTHERS: A small amount of pravastatin is excreted in breast milk. Because of the risk of toxicity to the infant, nursing mothers should not nurse while taking pravastatin.

SIDE EFFECTS: Like most statins, the most common side effects of pravastatin are headache, nausea, vomiting, diarrhea, muscle pain, and abnormal liver tests. The most serious potential side effects are liver damage and muscle inflammation or breakdown. Serious liver damage with statins is rare, however. More often, statins cause abnormalities of liver tests. Abnormal tests usually return to normal even if a statin is continued, but if the abnormal test is greater than three times the upper limit of normal, the statin usually is stopped. Liver tests should be measured before therapy is started and whenever there is a medical concern.

Inflammation of the muscles caused by statins can lead to a serious breakdown of muscle cells called rhabdomyolysis. When used alone, statins cause rhabdomyolysis in less than one percent of patients. Rhabdomyolysis causes the release of proteins from muscle (myoglobin) into the blood. Myoglobin can cause kidney failure and even death. To prevent the development of rhabdomyolysis, patients taking statins, including pravastatin, should contact their health care professional immediately if they develop unexplained muscle pain, weakness, or tenderness. S

ince pravastatin prevents heart attacks, strokes and death, its benefit usually outweighs its serious but rare side effects. There are post-marketing reports of memory loss, forgetfulness, amnesia, confusion, and memory impairment. Symptoms may start one day to years after starting treatment and resolve within a median of three weeks after stopping the statin.

REFERENCE: FDA Prescribing Information for Pravachol

Last Editorial Review: 5/1/2012

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