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LIPITOR Atorvastatin Calcium Tablets Adverse Reactions

Adverse Reactions

Adverse reactions with LIPITOR have usually been mild and transient. In the atorvastatin placebo-controlled clinical trial database of 16,066 (8755 Lipitor versus 7311 placebo) patients treated for a median period of 53 weeks , 5.2% of patients on atorvastatin discontinued due to adverse reactions compared to 4.0% of the patients on placebo.

Adverse experiences occurring at an incidence ≥1% in patients participating in placebo- controlled clinical studies of LIPITOR and reported to be possibly, probably or definitely drug related are shown in Table 1 below:

Table 1: Associated Adverse Events Reported in ≥ 1% of Patients in Placebo Controlled Clinical Trials
 

Atorvastatin % (n=8755)

Placebo % (n=7311)

Gastrointestinal disorders:

  
Diarrhea

6.8

6.3

Dyspepsia

4.6

4.3

Nausea

4.0

3.5

Constipation

3.9

4.3

Flatulence

1.2

1.0

General disorders and administration site conditions:  
Asthenia1.11.1

Infections and Infestations:
Nasopharyngitis

8.3

8.2

Metabolism and nutrition disorders:  
Liver function test abnormal*4.12.0

Blood creatine phosphokinase increased

1.9

1.8

Hyperglycemia

5.9

5.5

Musculoskeletal and connective tissue disorders:  
Arthralgia6.9

6.5

Pain in extremity

6.0

5.9

Musculoskeletal pain

3.8

3.6

Muscle spasms

3.6

3.0

Myalgia

3.5

3.1

Joint swelling

1.3

1.2

Nervous system disorders   
Headache6.56.7
Respiratory,thoracic and mediastinal disorders:  
Pharyngolaryngeal pain2.32.1

Epistaxis

1.2

1.1

*alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, hepatic enzyme increased, liver function test abnormal and transaminases increased.

The following additional adverse events were reported in placebo-controlled clinical trials during LIPITOR therapy: Muscle cramps, myositis, muscle fatigue, myopathy, paresthesia, peripheral neuropathy, pancreatitis, hepatitis, cholestatic jaundice, cholestasis, anorexia, vomiting, abdominal discomfort, alopecia, pruritus, rash, urticaria, erectile dysfunction, nightmare, vision blurred, tinnitus, eructation, neck pain, malaise, pyrexia and white blood cells urine positive.

In summary, the adverse events occurring at a frequency <1% are listed below:

General disorders and administration site conditions: malaise; pyrexia
Gastrointestinal disorders: abdominal discomfort, eructation
Hepatobiliary disorders: hepatitis, cholestasis
Musculoskeletal and connective tissue disorders: muscle fatigue, neck pain
Psychiatric disorders: nightmare
Skin and subcutaneous tissue disorders: urticaria
Eye disorders: vision blurred
Ear and labyrinth disorders: tinnitus
Investigations: white blood cells urine positive

Heterozygous Familial Hypercholesterolemia in Pediatric Patients (ages 10-17 years):

In a 26-week controlled study in boys and postmenarchal girls (n=187, where 140 patients received LIPITOR), the safety and tolerability profile of LIPITOR 10 to 20 mg daily was similar to that of placebo. The adverse events reported in ≥1% of patients were as follows: abdominal pain, depression and headache (see PHARMACOLOGY, Clinical Studies and PRECAUTIONS, Pediatric Use).

In an uncontrolled, open-label, 3-year study in children with heterozygous familial hypercholesterolemia ages 6 and above, physical growth (height, weight and BMI) and sexual maturation (Tanner Stage) appear to be consistent with the trend in the general pediatric population when atorvastatin was used as indicated. Patients should be evaluated for growth abnormalities if shifts in growth percentiles become evident. The safety and tolerability profile in pediatric patients had similar patterns to the known safety profile of atorvastatin in adult patients. Patients should be particularly monitored for liver enzymes (AST/ALT) and creatine kinase, and adverse events of interest (e.g.: headache, gastrointestinal, musculoskeletal and connective tissue disorders).

Laboratory Changes and Adverse Events

The criteria for clinically significant laboratory changes were >3 X the upper limit of normal (ULN) for liver enzymes, and >5 X ULN for creatine kinase. A total of 8 unique subjects met one or more of these criteria during the double-blind phase. Hence, the incidence of patients who experienced abnormally high enzymatic levels (AST/ALT and creatine kinase) was > 4% (8/187).

Five atorvastatin and one placebo subjects had increases in CK >5 X ULN during the double- blind phase; two of the five atorvastatin treated subjects had increases in CK > 10 X ULN.

There were 2 subjects who had clinically significant increases in ALT.

Abnormal Hematologic and Clinical Chemistry Findings

Laboratory Tests: Increases in serum transaminase levels and serum glucose have been noted in clinical trials (see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS).

Post-Market Adverse Drug Reactions

The following adverse events have also been reported during post-marketing experience with LIPITOR, regardless of causality assessment:

Rare reports: severe myopathy with or without rhabdomyolysis (see WARNINGS AND PRECAUTIONS, Muscle Effects, Renal Insufficiency and DRUG INTERACTIONS).

There have been rare reports of immune-mediated necrotizing myopathy with statins (see WARNINGS AND PRECAUTIONS, Muscle Effects).

Isolated reports: Gynecomastia, thrombocytopenia, arthralgia and allergic reactions including urticaria, angioedema (angioneurotic edema), anaphylaxis and bullous rashes (including erytheme multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis), fatigue, myositis, back pain, chest pain, malaise, dizziness, amnesia, peripheral edema, weight gain, abdominal pain, insomnia, hypoesthesia, tinnitus, tendon rupture, pancreatitis, dysgeusia and Ewing's sarcoma (pediatric).

Ophthalmologic observations: see WARNINGS AND PRECAUTIONS.

Cases of erectile dysfunction have been reported in association with the use of statins.

The following adverse events have been reported with some statins:

  • Sleep disturbances, including insomnia and nightmares;
  • Mood related disorders, including depression;
  • Very rare cases of interstitial lung disease, especially with long term therapy. If it is suspected a patient has developed interstitial lung disease, statin therapy should be discontinued.

Endocrine disorders: Increases in fasting glucose and HbA1c levels have been reported with LIPITOR.

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).

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