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.
Clinical Studies Experience
In the placebo-controlled clinical trials database of 402 patients (age range 21-75 years, 33% women, 89% Caucasians, 7% Blacks, 3% Hispanics, 1% Asians) with a median treatment duration of 16 weeks, 16% of patients on NIASPAN and 4% of patients on placebo discontinued due to adverse reactions. The most common adverse reactions in the group of patients treated with NIASPAN that led to treatment discontinuation and occurred at a rate greater than placebo were flushing (6% vs 0%), rash (2% vs 0%), diarrhea (2% vs 0%), nausea (1% vs 0%), and vomiting (1% vs. 0%). The most commonly reported adverse reactions (incidence >5% and greater than placebo) in the NIASPAN controlled clinical trial database of 402 patients were flushing, diarrhea, nausea, vomiting, increased cough and pruritus.
In the placebo-controlled clinical trials, flushing episodes (i.e., warmth, redness, itching and/or tingling) were the most common treatment-emergent adverse reactions (reported by as many as 88% of patients) for NIASPAN. Spontaneous reports suggest that flushing may also be accompanied by symptoms of dizziness, tachycardia, palpitations, shortness of breath, sweating, chills, and/or edema, which in rare cases may lead to syncope. In pivotal studies, 6% (14/245) of NIASPAN patients discontinued due to flushing. In comparisons of immediate-release (IR) niacin and NIASPAN, although the proportion of patients who flushed was similar, fewer flushing episodes were reported by patients who received NIASPAN. Following 4 weeks of maintenance therapy at daily doses of 1500 mg, the incidence of flushing over the 4-week period averaged 8.6 events per patient for IR niacin versus 1.9 following NIASPAN.
Other adverse reactions occurring in ≥5% of patients treated with NIASPAN and at an incidence greater than placebo are shown in Table 2 below.
Table 2. Treatment-Emergent Adverse Reactions by Dose Level in ≥ 5% of Patients and at an Incidence Greater than Placebo; Regardless of Causality Assessment in Placebo-Controlled Clinical Trials
| || Placebo-Controlled Studies |
Note: Percentages are calculated from the total number of patients in each column.
† Adverse reactions are reported at the initial dose where they occur.
@ Pooled results from placebo-controlled studies; for NIASPAN, n = 245 and median treatment duration = 16 weeks. Number of NIASPAN patients (n) are not additive across doses.
‡ The 500 mg/day dose is outside the recommended daily maintenance dosing range [see Dosage and Administration (2) ].
& 10 patients discontinued before receiving 500 mg, therefore they were not included.
| || || Recommended Daily |
Maintenance Doses †
| ||Placebo ||500 mg‡ ||1000 mg ||1500 mg ||2000 mg |
| ||(n = 157) ||(n = 87) ||(n = 110) ||(n = 136) ||(n = 95) |
| ||% ||% ||% ||% ||% |
| Gastrointestinal Disorders || || || || || |
|Diarrhea ||13 ||7 ||10 ||10 ||14 |
|Nausea ||7 ||5 ||6 ||4 ||11 |
|Vomiting ||4 ||0 ||2 ||4 ||9 |
| Respiratory || || || || || |
|Cough, Increased ||6 ||3 ||2 ||< 2 ||8 |
| Skin and Subcutaneous Tissue Disorders || || || || || |
|Pruritus ||2 ||8 ||0 ||3 ||0 |
|Rash ||0 ||5 ||5 ||5 ||0 |
| Vascular Disorders || || || || || |
|Flushing& ||19 ||68 ||69 ||63 ||55 |
In general, the incidence of adverse events was higher in women compared to men.
Because the below reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following additional adverse reactions have been identified during post-approval use of NIASPAN:
Hypersensitivity reactions, including anaphylaxis, angioedema, urticaria, flushing, dyspnea, tongue edema, larynx edema, face edema, peripheral edema, laryngismus, and vesiculobullous rash; maculopapular rash; dry skin; tachycardia; palpitations; atrial fibrillation; other cardiac arrhythmias; syncope; hypotension; postural hypotension; blurred vision; macular edema; peptic ulcers; eructation; flatulence; hepatitis; jaundice; decreased glucose tolerance; gout; myalgia; myopathy; dizziness; insomnia; asthenia; nervousness; paresthesia; dyspnea; sweating; skin discoloration, and migraine.
Clinical Laboratory Abnormalities
Chemistry: Elevations in serum transaminases [see Warnings and Precautions ], LDH, fasting glucose, uric acid, total bilirubin, amylase and creatine kinase, and reduction in phosphorus.
Hematology: Slight reductions in platelet counts and prolongation in prothrombin time [see Warnings and Precautions ].
REPORTS OF SUSPECTED NIASPAN SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Niaspan. The information is not vetted and should not be considered as verified clinical evidence.
Possible Niaspan side effects / adverse reactions in 50 year old female
Reported by a consumer/non-health professional from United States on 2011-10-11
Patient: 50 year old female weighing 93.0 kg (204.6 pounds)
Reactions: Dyspnoea, Chest Discomfort, Nausea, Oedema Peripheral, Heart Rate Increased, Dizziness, Lymphoedema, Eye Pain
Adverse event resulted in: life threatening event, hospitalization
Possible Niaspan side effects / adverse reactions in 70 year old male
Reported by a consumer/non-health professional from United States on 2011-10-13
Patient: 70 year old male weighing 100.7 kg (221.5 pounds)
Reactions: Flushing, Increased Upper Airway Secretion, Neck Pain, Musculoskeletal Pain, Headache, Feeling Abnormal, Cough
Dosage: 500mg 1 per day
Indication: Blood Cholesterol Increased
Start date: 2011-03-15
Dosage: 500mg 1 per day
Indication: Blood Triglycerides Increased
Start date: 2011-03-15
Possible Niaspan side effects / adverse reactions in 55 year old male
Reported by a physician from United States on 2011-11-23
Patient: 55 year old male
Reactions: Hepatotoxicity, Alanine Aminotransferase Increased, Coagulopathy, Angina Unstable, Aspartate Aminotransferase Increased, Abnormal Clotting Factor
Adverse event resulted in: hospitalization
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Diltiazem HCL; Aspirin