ADVERSE REACTIONS
Overview
In controlled clinical studies, 40/214 (19%) of patients randomized to ADVICOR discontinued therapy prior to study completion. Of the 214 patients enrolled 18 (8%) discontinued due to flushing. In the same controlled studies, 9/94 (10%) of patients randomized to lovastatin and 19/92 (21%) of patients randomized to NIASPAN also discontinued treatment prior to study completion secondary to adverse events. Flushing episodes (i.e., warmth, redness, itching and/or tingling) were the most common treatment-emergent adverse events, and occurred in 53% to 83% of patients treated with ADVICOR. Spontaneous reports with NIASPAN and clinical studies with ADVICOR suggest that flushing may also be accompanied by symptoms of dizziness or syncope, tachycardia, palpitations, shortness of breath, sweating, chills, and/or edema.
Adverse Reactions Information
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in 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 clinical practice. The adverse reaction information from clinical studies does, however provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
The data described in this section reflect the exposure to ADVICOR in two double-blind, controlled clinical studies of 400 patients. The population was 28 to 86 years-of-age, 54% male, 85% Caucasian, 9% Black, and 7% Other, and had mixed dyslipidemia (Frederickson Types IIa and IIb).
In addition to flushing, other adverse events occurring in 5% or greater of patients treated with ADVICOR are shown in Table 8 below.
Table 8. Treatment-Emergent Adverse Events in ≥ 5% of Patients (Events Irrespective of Causality; Data from Controlled, Double-Blind Studies) | Adverse Event | ADVICOR | NIASPAN | Lovastatin |
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Note: Percentages are calculated from the total number of patients in each column.
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| | | |
| Total Number of Patients | 214 | 92 | 94 |
| | | |
| Cardiovascular | 163 (76%) | 66 (72%) | 24 (26%) |
| Flushing | 152 (71%) | 60 (65%) | 17 (18%) |
| | | |
| Body as a Whole | 104 (49%) | 50 (54%) | 42 (45%) |
| Asthenia | 10 (5%) | 6 (7%) | 5 (5%) |
| Flu Syndrome | 12 (6%) | 7 (8%) | 4 (4%) |
| Headache | 20 (9%) | 12 (13%) | 5 (5%) |
| Infection | 43 (20%) | 14 (15%) | 19 (20%) |
| Pain | 18 (8%) | 3 (3%) | 9 (10%) |
| Pain, Abdominal | 9 (4%) | 1 (1%) | 6 (6%) |
| Pain, Back | 10 (5%) | 5 (5%) | 5 (5%) |
| | | |
| Digestive System | 51 (24%) | 26 (28%) | 16 (17%) |
| Diarrhea | 13 (6%) | 8 (9%) | 2 (2%) |
| Dyspepsia | 6 (3%) | 5 (5%) | 4 (4%) |
| Nausea | 14 (7%) | 11 (12%) | 2 (2%) |
| Vomiting | 7 (3%) | 5 (5%) | 0 |
| | | |
| Metabolic and Nutrit. System | 37 (17%) | 18 (20%) | 13 (14%) |
| Hyperglycemia | 8 (4%) | 6 (7%) | 6 (6%) |
| | | |
| Musculoskeletal System | 19 (9%) | 9 (10%) | 17 (18%) |
| Myalgia | 6 (3%) | 5 (5%) | 8 (9%) |
| | | |
| Skin and Appendages | 38 (18%) | 19 (21%) | 11 (12%) |
| Pruritus | 14 (7%) | 7 (8%) | 3 (3%) |
| Rash | 11 (5%) | 11 (12%) | 3 (3%) |
The following adverse events have also been reported with niacin, lovastatin, and/or other HMG-CoA reductase inhibitors, but not necessarily with ADVICOR, either during clinical studies or in routine patient management.
| Body as a Whole: | chest pain; abdominal pain; edema; chills; malaise |
| Cardiovascular: | atrial fibrillation; tachycardia; palpitations, and other cardiac arrhythmias; orthostasis; hypotension; syncope |
| Eye: | toxic amblyopia; cystoid macular edema; ophthalmoplegia; eye irritation |
| Gastrointestinal: | activation of peptic ulcers and peptic ulceration; dyspepsia; vomiting; anorexia; constipation; flatulence, pancreatitis; hepatitis; fatty change in liver; jaundice; and rarely, cirrhosis, fulminant hepatic necrosis, and hepatoma |
| Metabolic: | gout |
| Musculoskeletal: | muscle cramps; myopathy; rhabdomyolysis; arthralgia |
| Nervous: | dizziness; insomnia; dry mouth; paresthesia; anxiety; tremor; vertigo; memory loss; peripheral neuropathy; psychic disturbances; dysfunction of certain cranial nerves |
| Skin: | hyper-pigmentation; acanthosis nigricans; urticaria; alopecia; dry skin; sweating; and a variety of skin changes (e.g., nodules, discoloration, dryness of mucous membranes, changes to hair/nails) |
| Respiratory: | dyspnea; rhinitis |
| Urogenital: | gynecomastia; loss of libido; erectile dysfunction |
| Hypersensitivity reactions: | An apparent hypersensitivity syndrome has been reported rarely, which has included one or more of the following features: anaphylaxis, angioedema, lupus erythematous-like syndrome, polymyalgia rheumatica, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive ANA, ESR increase, eosinophilia, arthritis, arthralgia, urticaria, asthenia, photosensitivity, fever, chills, flushing, malaise, dyspnea, toxic epidermal necrolysis, erythema multiforme, including Stevens-Johnson syndrome. |
| Other: | migraine |
Clinical Laboratory Abnormalities
Chemistry
Elevations in serum transaminases (see WARNINGS - Liver Dysfunction), CPK and fasting glucose, and reductions in phosphorus. Niacin extended-release tablets have been associated with slight elevations in LDH, uric acid, total bilirubin, and amylase. Lovastatin and/or HMG-CoA reductase inhibitors have been associated with elevations in alkaline phosphatase,γ-glutamyl transpeptidase and bilirubin, and thyroid function abnormalities.
Hematology
Niacin extended-release tablets have been associated with slight reductions in platelet counts and prolongation in PT (see WARNINGS).
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REPORTS OF SUSPECTED ADVICOR SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Advicor. The information is not vetted and should not be considered as verified clinical evidence.
Possible Advicor side effects / adverse reactions in 67 year old male
Reported by a consumer/non-health professional from United States on 2011-12-19
Patient: 67 year old male
Reactions: Sweat Discolouration
Suspect drug(s):
Advicor
Other drugs received by patient: Diovan; Meloxicam
Possible Advicor side effects / adverse reactions in 57 year old male
Reported by a physician from United States on 2012-03-07
Patient: 57 year old male
Reactions: Liver Injury, Oral Surgery, Plasmacytosis, Cardiac Murmur, Bone Graft, Product Contamination Microbial, Hepatitis C, Hepatitis Acute, Coagulopathy, International Normalised Ratio Increased, Headache, Iatrogenic Infection
Suspect drug(s):
Advicor
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