| |
Adverse Drug Reaction Overview
Analysis of the adverse events in a population consisting of 942 patients diagnosed with myeloproliferative diseases of varying etiology [Essential Thrombocythemia (ET): 551; Polycythemia Vera (PV): 117; other myeloproliferative disorders (OMPD): 274] has shown that all disease groups have the same adverse event profile. While most reported adverse events during AGRYLIN (anagrelide hydrochloride) therapy have been mild in intensity and have decreased in frequency with continued therapy, serious adverse events reported were reported in these patients. These include the following: congestive heart failure, myocardial infarction, cardiomyopathy, cardiomegaly, complete heart block, atrial fibrillation, cerebrovascular accident, pericarditis, pericardial effusion, pleural effusion, pulmonary infiltrates, pulmonary fibrosis, pulmonary hypertension, pancreatitis, gastric/duodenal ulceration, and seizure.
The mean duration of AGRYLIN therapy for ET, PV, Chronic Myelogenous Leukemia (CML) and OMPD patients was 65, 67, 40 and 44 weeks, respectively. Of the 942 patients treated with AGRYLIN, 161 (17%) were discontinued from the study because of adverse events or abnormal laboratory test results. The most common adverse events for treatment discontinuation were headache, diarrhea, edema, palpitation, and abdominal pain. Overall, the occurrence rate of all adverse events was 17.9 per 1000 treatment days. The occurrence rate of adverse events increased at higher dosages of AGRYLIN.
Clinical Trial Adverse Drug Reactions
Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.
The most frequently reported adverse reactions to AGRYLIN (in 5% or greater of 942 patients with myeloproliferative disease) in clinical trials are included in Table 1.
Table 1: AGRYLIN Adverse Events with an Incidence of ≥5%
| |
AGRYLIN |
| Body as a Whole |
Chills, flu symptoms, infection, neck pain, accidental injury, photosensitivity, cellulites. |
| Cardiovascular |
Arrhythmia, hemorrhage, cardiovascular disease, angina pectoris, heart failure, congestive heart failure, vasodilatation, postural hypotension, migraine, syncope, hypotension, thrombosis, hypertension. |
| Digestive |
Constipation, GI hemorrhage, GI distress, melena, nausea and vomiting, gastritis, dysphagia, eructation, dry mouth. |
| Hemic and Lymphatic |
Anemia, thrombocytopenia, ecchymosis, lymphadenoma.
Platelet counts below 100 000/µL occurred in 84 patients (ET: 35; PV: 9; OMPD: 40) and reduction below 50 000/µL occurred in 44 patients (ET: 7; PV: 6; OMPD: 31) while on AGRYLIN therapy. Thrombocytopenia promptly recovered upon discontinuation of AGRYLIN.
|
| Hepatic |
Elevated liver enzymes were observed in 3 patients (ET: 2; OMPD: 1) during AGRYLIN therapy. |
| Musculoskeletal |
Arthralgia, myalgia, leg cramps, arthritis, bone pain. |
| Nervous |
Depression, somnolence, insomnia, confusion, nervousness, amnesia. |
| Nutritional Disorders |
Weight loss, weight gain, oedema, dehydration. |
| Respiratory |
Rhinitis, epistaxis, respiratory disease, sinusitis, pneumonia, bronchitis, asthma. |
| Skin and Appendages |
Sweating, skin disease, alopecia, skin ulcer, skin discoloration. |
| Special Senses |
Amblyopia, abnormal vision, ear disorder, conjunctivitis, visual field abnormality, tinnitus, eye disorder, diplopia. |
| Urogenital |
Urinary tract disorder, urinary frequency, hematuria, urinary tract infection, dysuria, nocturia, urinary incontinence. |
|
