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Niaspan (Niacin Extended-Release) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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, burning sensation/skin burning sensation, 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 below. Table 2

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 NIASPAN Treatment
@
    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
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. 10 patients discontinued before receiving 500 mg, therefore they were not included.

@
[see Dosage and Administration ] (2)
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In general, the incidence of adverse events was higher in women compared to men.

Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health Outcomes (AIM-HIGH)

In AIM-HIGH involving 3414 patients (mean age of 64 years, 15% women, 92% Caucasians, 34% with diabetes mellitus) with stable, previously diagnosed cardiovascular disease, all patients received simvastatin, 40 to 80 mg per day, plus ezetimibe 10 mg per day if needed, to maintain an LDL-C level of 40-80 mg/dL, and were randomized to receive NIASPAN 1500-2000 mg/day (n=1718) or matching placebo (IR Niacin, 100-150 mg, n=1696).  The incidence of the adverse reactions of “blood glucose increased” (6.4% vs. 4.5%) and “diabetes mellitus” (3.6% vs. 2.2%) was significantly higher in the simvastatin plus NIASPAN group as compared to the simvastatin plus placebo group.  There were 5 cases of rhabdomyolysis reported, 4 (0.2%) in the simvastatin plus NIASPAN group and one (<0.1%) in the simvastatin plus placebo group. [see Warnings and Precautions ]

Postmarketing Experience

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; burning sensation/skin burning sensation; skin discoloration, and migraine.

Clinical Laboratory Abnormalities

Elevations in serum transaminases, LDH, fasting glucose, uric acid, total bilirubin, amylase and creatine kinase, and reduction in phosphorus. Chemistry: [see Warnings and Precautions ]

Slight reductions in platelet counts and prolongation in prothrombin time. Hematology: [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

Suspect drug(s):
Niaspan



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

Suspect drug(s):
Niaspan
    Dosage: 500mg 1 per day
    Indication: Blood Cholesterol Increased
    Start date: 2011-03-15

Niaspan
    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

Suspect drug(s):
Niaspan

Niaspan
    Indication: Product Used FOR Unknown Indication

Niaspan

Other drugs received by patient: Diltiazem HCL; Aspirin



See index of all Niaspan side effect reports >>

Drug label data at the top of this Page last updated: 2013-08-20

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