6 ADVERSE REACTIONS Pravastatin is generally well tolerated; adverse reactions have usually been mild and transient. 2% of placebo-treated patients were discontinued from treatment because of adverse experiences attributed to study drug therapy; this difference was not statistically significant.
In short-term clinical trials, the most commonly reported adverse reactions (≥2% and > placebo) regardless of causality were: musculoskeletal pain, nausea/vomiting, upper respiratory infection, diarrhea, and headache. 1) To report SUSPECTED ADVERSE REACTIONS, contact Biocon Pharma Inc.
gov/medwatch. 2% patients on placebo discontinued due to adverse events regardless of causality. The most common adverse reactions that led to treatment discontinuation and occurred at an incidence greater than placebo were: liver function test increased, nausea, anxiety/depression, and dizziness.
6 months was similar to that of Pravastatin Sodium at lower doses except that 4 out of 464 patients taking 80 mg of pravastatin had a single elevation of CK >10 times ULN compared to 0 out of 115 patients taking 40 mg of pravastatin.
3% patients on placebo discontinued due to adverse events regardless of causality. Adverse event data were pooled from 7 double-blind, placebo-controlled trials (West of Scotland Coronary Prevention Study [WOS]; Cholesterol and Recurrent Events study [CARE]; Long-term Intervention with Pravastatin in Ischemic Disease study [LIPID]; Pravastatin Limitation of Atherosclerosis in the Coronary Arteries study [PLAC I]; Pravastatin, Lipids and Atherosclerosis in the Carotids study [PLAC II]; Regression Growth Evaluation Statin Study [REGRESS]; and Kuopio Atherosclerosis Prevention Study [KAPS]) involving a total of 10,764 patients treated with pravastatin 40 mg and 10,719 patients treated with placebo.
The safety and tolerability profile in the pravastatin group was comparable to that of the placebo group. 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 complaints.
Collectively, these 7 trials represent 47,613 patient-years of exposure to pravastatin. All clinical adverse events (regardless of causality) occurring in ≥2% of patients treated with pravastatin in these studies are identified in Table 2.
0% of pravastatin-treated patients in the long-term trials included the following: Dermatologic: scalp hair abnormality (including alopecia), urticaria. Endocrine/Metabolic: sexual dysfunction, libido change. General: flushing. Immunologic: allergy, edema head/neck.
Musculoskeletal: muscle weakness. Nervous System: vertigo, insomnia, memory impairment, neuropathy (including peripheral neuropathy). Special Senses: taste disturbance. 2 Postmarketing Experience In addition to the events reported above, as with other drugs in this class, the following events have been reported during postmarketing experience with Pravastatin Sodium, regardless of causality assessment: Musculoskeletal: myopathy, rhabdomyolysis, tendon disorder, polymyositis.
2 ) ]. Nervous System: dysfunction of certain cranial nerves (including alteration of taste, impairment of extraocular movement, facial paresis), peripheral nerve palsy. , memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use.
These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).
Hypersensitivity: anaphylaxis, angioedema, 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: abdominal pain, constipation, pancreatitis, hepatitis (including chronic active hepatitis), cholestatic jaundice, fatty change in liver, cirrhosis, fulminant hepatic necrosis, hepatoma, fatal and non-fatal hepatic failure.
, nodules, discoloration, dryness of mucous membranes, changes to hair/nails). Renal: urinary abnormality (including dysuria, frequency, nocturia). Respiratory: dyspnea, interstitial lung disease. Psychiatric: nightmare. Reproductive: gynecomastia.
Laboratory Abnormalities: liver function test abnormalities, thyroid function abnormalities. 3 ) ]. Transient, asymptomatic eosinophilia has been reported. Eosinophil counts usually returned to normal despite continued therapy. 5 years, 53% female, 95% Caucasians, <1% Blacks, 3% Asians, 1% Other), the safety and tolerability profile of pravastatin was generally similar to that of placebo.
3) . 2% patients on placebo discontinued due to adverse events regardless of causality. The most common adverse reactions that led to treatment discontinuation and occurred at an incidence greater than placebo were: liver function test increased, nausea, anxiety/depression, and dizziness.
6 months was similar to that of Pravastatin Sodium at lower doses except that 4 out of 464 patients taking 80 mg of pravastatin had a single elevation of CK >10 times ULN compared to 0 out of 115 patients taking 40 mg of pravastatin.
3% patients on placebo discontinued due to adverse events regardless of causality. Adverse event data were pooled from 7 double-blind, placebo-controlled trials (West of Scotland Coronary Prevention Study [WOS]; Cholesterol and Recurrent Events study [CARE]; Long-term Intervention with Pravastatin in Ischemic Disease study [LIPID]; Pravastatin Limitation of Atherosclerosis in the Coronary Arteries study [PLAC I]; Pravastatin, Lipids and Atherosclerosis in the Carotids study [PLAC II]; Regression Growth Evaluation Statin Study [REGRESS]; and Kuopio Atherosclerosis Prevention Study [KAPS]) involving a total of 10,764 patients treated with pravastatin 40 mg and 10,719 patients treated with placebo.
The safety and tolerability profile in the pravastatin group was comparable to that of the placebo group. 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 complaints.
Collectively, these 7 trials represent 47,613 patient-years of exposure to pravastatin. All clinical adverse events (regardless of causality) occurring in ≥2% of patients treated with pravastatin in these studies are identified in Table 2.
0% of pravastatin-treated patients in the long-term trials included the following: Dermatologic: scalp hair abnormality (including alopecia), urticaria. Endocrine/Metabolic: sexual dysfunction, libido change. General: flushing. Immunologic: allergy, edema head/neck.
Musculoskeletal: muscle weakness. Nervous System: vertigo, insomnia, memory impairment, neuropathy (including peripheral neuropathy). Special Senses: taste disturbance. 2 Postmarketing Experience In addition to the events reported above, as with other drugs in this class, the following events have been reported during postmarketing experience with Pravastatin Sodium, regardless of causality assessment: Musculoskeletal: myopathy, rhabdomyolysis, tendon disorder, polymyositis.
2 ) ]. Nervous System: dysfunction of certain cranial nerves (including alteration of taste, impairment of extraocular movement, facial paresis), peripheral nerve palsy. , memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use.
These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).
Hypersensitivity: anaphylaxis, angioedema, 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: abdominal pain, constipation, pancreatitis, hepatitis (including chronic active hepatitis), cholestatic jaundice, fatty change in liver, cirrhosis, fulminant hepatic necrosis, hepatoma, fatal and non-fatal hepatic failure.
, nodules, discoloration, dryness of mucous membranes, changes to hair/nails). Renal: urinary abnormality (including dysuria, frequency, nocturia). Respiratory: dyspnea, interstitial lung disease. Psychiatric: nightmare. Reproductive: gynecomastia.
Laboratory Abnormalities: liver function test abnormalities, thyroid function abnormalities. 3 ) ]. Transient, asymptomatic eosinophilia has been reported. Eosinophil counts usually returned to normal despite continued therapy. 5 years, 53% female, 95% Caucasians, <1% Blacks, 3% Asians, 1% Other), the safety and tolerability profile of pravastatin was generally similar to that of placebo.
3) . ]