Pravachol

[Pravastatin]

The safety and tolerability profile in the pravastatin group was comparable to that of the placebo group. Patients were exposed to pravastatin for a mean of 4.0 to 5.1 years in WOS, CARE, and LIPID and 1.9 to 2.9 years in PLAC I, PLAC II, KAPS, and REGRESS. In these long-term trials, the most common reasons for discontinuation were mild, non-specific gastrointestinal com-plaints.

Collectively, these seven trials represent 47,613 patient-years of exposure to pravastatin. Events believed to be of probable, possible, or uncertain relationship to study drug, occurring in at least 1% of patients treated with pravastatin in these studies are identified in Table 8.

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Events of probable, possible, or uncertain relationship to study drug that occurred in <1.0% of pravastatin-treated patients in the long-term trials included the following; frequencies were similar in placebo-treated patients:

Dermatologic

pruritus, dermatitis, dryness of skin, scalp hair abnormality (including alopecia), urticaria.

Endocrine/ Metabolic:

sexual dysfunction, libido change.

Gastrointestinal

decreased appetite.

General

fever, flushing.

Immunologic

allergy, edema head/ neck.

Musculoskeletal: muscle weakness.

Nervous System

paresthesia, vertigo, insomnia, memory impairment, tremor, neuropathy (including peripheral neuropathy).

Special Senses

lens opacity, taste disturbance.

Postmarketing Experience

In addition to the events reported above, as with other drugs in this class, the following events have been reported rarely during postmarketing experience with PRAVACHOL (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.

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