Fenofibric Acid Delayed-Release (Page 3 of 8)

6 ADVERSE REACTIONS

The following serious adverse reactions are described below and elsewhere in the labeling:

  • Mortality and coronary heart disease morbidity [see Warnings and Precautions (5.1)]
  • Hepatoxicity [see Warnings and Precautions (5.2)]
  • Pancreatitis [see Warnings and Precautions (5.7)]
  • Hypersensitivity reactions [see Warnings and Precautions (5.9)]
  • Venothromboembolic disease [see Warnings and Precautions (5.10)]

6.1 Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Fenofibric acid is the active metabolite of fenofibrate. Adverse events reported by 2% or more of patients treated with fenofibrate and greater than placebo during double-blind, placebo-controlled trials are listed in Table 1. Adverse events led to discontinuation of treatment in 5.0% of patients treated with fenofibrate and in 3.0% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of fenofibrate treatment in 1.6% of patients in double-blind trials.

Table 1. Adverse Events Reported by 2% or More of Patients Treated with Fenofibrate and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials
* Dosage equivalent to 135 mg fenofibric acid delayed-release capsules

BODY SYSTEM

Adverse Event

Fenofibrate*(N= 439)

Placebo(N = 365)

BODY AS A WHOLE

Abdominal Pain

4.6%

4.4%

Back Pain

3.4%

2.5%

Headache

3.2%

2.7%

DIGESTIVE

Nausea

2.3%

1.9%

Constipation

2.1%

1.4%

INVESTIGATIONS

Abnormal Liver Tests

7.5%

1.4%

Increased AST

3.4%

0.5%

Increased ALT

3.0%

1.6%

Increased Creatine Phosphokinase

3.0%

1.4%

RESPIRATORY

Respiratory Disorder

6.2%

5.5%

Rhinitis

2.3%

1.1%

Urticaria was seen in 1.1% vs. 0%, and rash in 1.4% vs. 0.8% of fenofibrate and placebo patients respectively in controlled trials.

Clinical trials with fenofibric acid delayed-release capsules did not include a placebo-control arm. However, the adverse event profile of fenofibric acid delayed-release capsules was generally consistent with that of fenofibrate. The following adverse events not listed above were reported in 3% of patients taking fenofibric acid delayed-release capsules alone:

Gastrointestinal Disorders: Diarrhea, dyspepsia

General Disorders and Administration Site Conditions: Pain

Infections and Infestations: Nasopharyngitis, sinusitis, upper respiratory tract infection

Musculoskeletal and Connective Tissue Disorders: Arthralgia, myalgia, pain in extremity

Nervous System Disorders: Dizziness

Increases in Liver Enzymes

In a pooled analysis of three 12-week, double-blind, controlled studies of fenofibric acid delayed-release capsules, increases in ALT and AST > 3 times the upper limit of normal on two consecutive occasions occurred in 1.9% and 0.2%, respectively, of patients receiving fenofibric acid delayed-release capsules 135 mg daily and placebo, without other lipid-altering drugs. In a pooled analysis of 10 placebo-controlled trials, increases to > 3 times the upper limit of normal in ALT occurred in 5.3% of patients taking fenofibrate versus 1.1% of patients treated with placebo. In an 8-week study, the incidence of ALT or AST elevations ≥ 3 times the upper limit of normal was 13% in patients receiving dosages equivalent to 90 mg to 135 mg fenofibric acid delayed-release capsules daily and was 0% in those receiving dosages equivalent to 45 mg or less fenofibric acid delayed-release capsules daily or placebo.

6.2 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of fenofibrate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: rhabdomyolysis, pancreatitis, renal failure, muscle spasms, acute renal failure, hepatitis, cirrhosis, increased total bilirubin, anemia, asthenia, severely depressed HDL-cholesterol levels, and interstitial lung disease. Photosensitivity reactions to fenofibrate have occurred days to months after initiation; in some of these cases, patients reported a prior photosensitivity reaction to ketoprofen.

7 DRUG INTERACTIONS

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