"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
In an uncontrolled, compassionate plea protocol, 125 of 1,378 patients reported a total of 301 adverse reactions while receiving ALOPRIM (allopurinol sodium) for Injection. Most of the patients had advanced malignancies or serious underlying diseases and were taking multiple concomitant medications. Side effects directly attributable to ALOPRIM (allopurinol sodium) for Injection were reported in 19 patients. Fifteen of these adverse experiences were allergic in nature (rash, eosinophilia, local injection site reaction). One adverse experience of severe diarrhea and one incidence of nausea were also reported as being possibly attributable to ALOPRIM (allopurinol sodium) for Injection. Two patients had serious adverse experiences (decreased renal function and generalized seizure) reported as being possibly attributable to ALOPRIM (allopurinol sodium) for Injection.
A listing of the adverse reactions regardless of causality reported from clinical trials follows:
Incidence Greater Than 1%
Cutaneous/Dermatologic: rash (1.5%)
Genitourinary: renal failure/insufficiency (1.2%)
Gastrointestinal: nausea (1.3%), vomiting (1.2%)
Incidence Less Than 1%
|Body as Whole:||fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia|
|Cardiovascular:||heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECGabnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation|
|Cutaneous/Dermatologic:||urticaria, pruritus, local injection site reaction|
|Gastrointestinal:||diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis|
|Genitourinary:||hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection|
|Hematologic:||leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation|
|Metabolic:||hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia|
|Neurologic:||seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor|
|Pulmonary:||respiratory failure/insufficiency, ARDS, increased respiration rate, apnea|
|Other:||hypotonia, diaphoresis, tumor lysis syndrome|
The most frequent adverse reaction to oral allopurinol is skin rash. Skin reactions can be severe and sometimes fatal. Therefore, treatment with ALOPRIM (allopurinol sodium for injection) (allopurinol sodium) for Injection should be discontinued immediately if a rash develops (see WARNINGS). For further details on hypersensitivity reactions to treatment with oral allopurinol, refer to the package insert for allopurinol tablets.
Read the Aloprim (allopurinol sodium for injection) Side Effects Center for a complete guide to possible side effects
The following drug interactions were observed in some patients undergoing treatment with oral allopurinol. Although the pattern of use for oral allopurinol includes longer term therapy, particularly for gout and renal calculi, the experience gained may be relevant.
Mercaptopurine/Azathioprine: Allopurinol inhibits the enzymatic oxidation of mercaptopurine and azathioprine to 6-thiouric acid. This oxidation, which is catalyzed by xanthine oxidase, inactivates mercaptopurine. Therefore, the concomitant administration of 300 to 600 mg of oral allopurinol per day will require a reduction in dose to approximately one-third to one-fourth of the usual dose of mercaptopurine or azathioprine. Subsequent adjustment of doses of mercaptopurine or azathioprine should be made on the basis of therapeutic response and the appearance of toxic effects.
Dicumarol: It has been reported that allopurinol prolongs the half-life of the anticoagulant, dicumarol. Consequently, prothrombin time should be reassessed periodically in patients receiving both drugs. The clinical basis of this drug interaction has not been established.
Uricosuric Agents: Since the excretion of oxypurinol is similar to that of urate, uricosuric agents, which increase the excretion of urate, are also likely to increase the excretion of oxypurinol. As a result, the concomitant administration of uricosuric agents decreases the inhibition of xanthine oxidase by oxypurinol and increases the urinary excretion of uric acid.
Thiazide Diuretics: Reports that the concomitant administration of allopurinol and thiazide diuretics contributed to increased allopurinol toxicity were reviewed; a causal mechanism or cause-and-effect relationship was not found. Renal function should be monitored in patients on thiazide diuretics and allopurinol (see WARNINGS).
Ampicillin/Amoxicillin: An increase in the frequency of skin rash has been reported among patients receiving ampicillin or amoxicillin concurrently with allopurinol compared to patients who are not receiving both drugs. The cause of this reaction has not been established.
Cytotoxic Agents: Enhanced bone marrow suppression by cyclophosphamide and other cytotoxic agents has been reported among patients with neoplastic disease, except leukemia, in the presence of allopurinol. However, in a well-controlled study of patients with lymphoma on combination therapy, allopurinol did not increase the marrow toxicity of patients treated with cyclophosphamide, doxorubicin, bleomycin, procarbazine, and/or mechlorethamine.
Chlorpropamide: The half-life of chlorpropamide in the plasma may be prolonged by allopurinol, since allopurinol and chlorpropamide may compete for excretion in the renal tubule. The risk of hypoglycemia secondary to this mechanism may be increased if allopurinol and chlorpropamide are given concomitantly in the presence of renal insufficiency.
Cyclosporin: Reports indicate that cyclosporine levels may be increased during concomitant treatment with ALOPRIM (allopurinol sodium) for Injection. Monitoring of cyclosporine levels and possible adjustment of cyclosporine dosage should be considered when these drugs are co-administered.
Drug/Laboratory Test Interactions: Allopurinol is not known to alter the accuracy of laboratory tests.
Read the Aloprim Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 11/18/2016
Additional Aloprim Information
- Aloprim Drug Interactions Center: allopurinol sodium iv
- Aloprim Side Effects Center
- Aloprim FDA Approved Prescribing Information including Dosage
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