The true safety picture of a drug is often not clear until after many thousands of people have taken it. Three long-term studies collected data on more than 112,000 person-years of use of the cholesterol-lowering agent pravastatin.

They found that, during five years of use, there were no differences in noncardiovascular serious side effects or cancer among patients taking 40 mg of the drug or a placebo. Neither was there any difference in the incidence of abnormal liver function tests. In fact, when factors such as age, diabetes, smoking, and serious cardiovascular adverse events were taken into consideration, it appeared that patients tolerated the drug better than the placebo.

The studies were randomized clinical trials, conducted at Brigham and Women's Hospital in Boston, University of Sydney in Australia, University of Glasgow in UK, Wake Forest University, and University of Texas Health Science Center, with support from the drug's manufacturer.

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Source:  Pfeffer MA, Keech A, Sacks FM, et al. Safety and tolerability of pravastatin in long-term clinical trials. Circulation, May 2002; 105:2341. (Abs.)