Apo-Pravastatin Adverse Reactions

In seven randomized, double-blind, placebo-controlled trials involving over 21,500 patients treated with pravastatin (N=10,784) or placebo (N=10,719), the safety and tolerability in the pravastatin group were comparable to that of the placebo group. Over 19,000 patients were followed for a median of 4.8-5.9 years, while the remaining patients were followed for two years or more.
Clinical adverse events probably or possibly related, or of uncertain relationship to therapy, occurring in at least 0.5% of patients treated with pravastatin or placebo in these long-term morbidity/mortality trials are shown in the table as follows: See Table 2.

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The following additional events were reported in either uncontrolled clinical trials or in marketed use: pruritus, scalp hair abnormalities, skin dryness, abnormal stool, appetite change, chest pain (non-cardiovascular), weakness, excess sweating, hot flashes, paresthesia, equilibrium disturbance, mood change, eye symptoms (including soreness, dryness, or itching), tinnitus and impotence (see Precaution).
Adverse Clinical Reactions: All adverse clinical events (regardless of attribution) reported in greater than 2% of patients in placebo-controlled studies of up to four months duration are presented in the following table: See Table 3.

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In two large placebo-controlled trials (West of Scotland Study [WOS] and Cholesterol and Recurrent Events Study [CARE] involving a total of 10,754 patients treated with pravastatin (N=5383) or placebo (N=5371), the safety and tolerability profile in the pravastatin group was comparable to that of the placebo group over the median 4.8-4.9 years of follow-up.
Postmarketing Experience: In addition to the events reported previously, as with other drugs in this class, the following events have been reported rarely during postmarketing experience with APO-PRAVASTATIN (pravastatin sodium), regardless of causality assessment: Musculoskeletal: myopathy, rhabdomyolysis.
Nervous System: dysfunction of certain cranial nerves (including alteration of taste, impairment of extra-ocular movement, facial paresis), peripheral nerve palsy.
Hypersensitivity: anaphylaxis, lupus erythematosus-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, purpura, hemolytic anemia, positive ANA, ESR increase, arthritis, arthralgia, asthenia, photosensitivity, chills, malaise, toxic epidermal necrolysis, erythema multiforme, including Stevens-Johnson syndrome.
Gastrointestinal: pancreatitis, hepatitis, including chronic active hepatitis, cholestatic jaundice, fatty change in liver, cirrhosis, fulminant hepatic necrosis, hepatoma.
Dermatologic: a variety of skin changes (e.g. nodules, discoloration, dryness of mucous membranes, changes to hair/nails).
Reproductive: gynecomastia.
Laboratory abnormalities: elevated alkaline phosphatase and bilirubin; thyroid function abnormalities.
The following have also been reported with other statins: hepatitis, cholestatic jaundice, anorexia, psychic disturbances including anxiety, hypospermia and hypersensitivity (see PRECAUTIONS).
There have been rare post-marketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins. The reports are generally non-serious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).
Increases in HbA1c and fasting serum glucose levels have been reported with statins.
Lens: Current data from clinical trials do not indicate an adverse effect of pravastatin on the human lens.
Laboratory Test Abnormalities: Increases in serum transaminases and in creatine phosphokinase (CPK) in patients treated with pravastatin have been discussed (see WARNINGS).