Pravastatin Sodium Side Effects

6 ADVERSE REACTIONS Pravastatin is generally well tolerated;

adverse reactions have usually been mild and transient.

In 4-month-long placebo-controlled trials, 1.7% of pravastatin-treated patients and 1.2% 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.

(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Biocon Pharma Inc.

at 1-866-924-6266 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Adverse Clinical Events Short-Term Controlled Trials In the Pravastatin Sodium placebo-controlled clinical trials database of 1313 patients (age range 20-76 years, 32.4% women, 93.5% Caucasians, 5% Blacks, 0.9% Hispanics, 0.4% Asians, 0.2% Others) with a median treatment duration of 14 weeks, 3.3% of patients on Pravastatin Sodium and 1.2% 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.

All adverse clinical events (regardless of causality) reported in ≥2% of pravastatin-treated patients in placebo-controlled trials of up to 8 months duration are identified in Table 1: Table 1: Adverse Events in ≥2% of Patients Treated with Pravastatin 5 to 40 mg and at an Incidence Greater Than Placebo in Short-Term Placebo-Controlled Trials (% of patients) Body System/Event 5 mg N=100 10 mg N=153 20 mg N=478 40 mg N=171 Any Dose N=902 Placebo N=411 Cardiovascular Angina Pectoris 5.0 4.6 4.8 3.5 4.5 3.4 Dermatologic Rash 3.0 2.6 6.7 1.2 4.5 1.4 Gastrointestinal Nausea/Vomiting Diarrhea Flatulence Dyspepsia/Heartburn Abdominal Distension 4.0 8.0 2.0 0.0 2.0 5.9 8.5 3.3 3.3 3.3 10.5 6.5 4.6 3.6 2.1 2.3 4.7 0.0 0.6 0.6 7.4 6.7 3.2 2.5 2.0 7.1 5.6 4.4 2.7 2.4 General Fatigue Chest Pain Influenza 4.0 4.0 4.0 1.3 1.3 2.6 5.2 3.3 1.9 0.0 1.2 0.6 3.4 2.7 2.0 3.9 1.9 0.7 Musculoskeletal Musculoskeletal Pain Myalgia 13.0 1.0 3.9 2.6 13.2 2.9 5.3 1.2 10.1 2.3 10.2 1.2 Nervous System Headache Dizziness 5.0 4.0 6.5 1.3 7.5 5.2 3.5 0.6 6.3 3.5 4.6 3.4 Respiratory Pharyngitis Upper Respiratory Infection Rhinitis Cough 2.0 6.0 7.0 4.0 4.6 9.8 5.2 1.3 1.5 5.2 3.8 3.1 1.2 4.1 1.2 1.2 2.0 5.9 3.9 2.5 2.7 5.8 4.9 1.7 Investigation ALT Increased g-GT Increased CPK Increased 2.0 3.0 5.0 2.0 2.6 1.3 4.0 2.1 5.2 1.2 0.6 2.9 2.9 2.0 4.1 1.2 1.2 3.6 The safety and tolerability of Pravastatin Sodium at a dose of 80 mg in 2 controlled trials with a mean exposure of 8.6 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.