"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
The assessment of clinical adverse events came from 206 patients treated with sodium phenylbutyrate. Adverse events (both clinical and laboratory) were not collected systematically in these patients, but were obtained from patient-visit reports by the 65 co-investigators. Causality of adverse effects is sometimes difficult to determine in this patient population because they may result from either the underlying disease, the patient's restricted diet, intercurrent illness, or BUPHENYL. Furthermore, the rates may be under-estimated because they were reported primarily by parent or guardian and not the patient.
Clinical Adverse Events
In female patients, the most common clinical adverse event reported was amenorrhea/menstrual dysfunction (irregular menstrual cycles), which occurred in 23% of the menstruating patients.
Decreased appetite occurred in 4% of all patients. Body odor (probably caused by the metabolite, phenylacetate) and bad taste or taste aversion were each reported in 3% of patients.
Other adverse events reported in 2% or fewer patients were:
Hematologic: aplastic anemia and ecchymoses each occurred in one patient.
Cardiovascular: arrhythmia and edema each occurred in one patient.
Renal: renal tubular acidosis
Miscellaneous: headache, syncope, and weight gain
Neurotoxicity was reported in cancer patients receiving intravenous phenylacetate, 250–300 mg/kg/day for 14 days, repeated at 4-week intervals. Manifestations were predominately somnolence, fatigue, and lightheadedness; with less frequent headache, dysgeusia, hypoacusis, disorientation, impaired memory, and exacerbation of a pre-existing neuropathy. These adverse events were mainly mild in severity. The acute onset and reversibility when the phenylacetate infusion was discontinued suggest a drug effect.
Laboratory Adverse Events
In patients with urea cycle disorders, the frequency of laboratory adverse events by body system were:
Nutritional: hypoalbuminemia (11%) and decreased total protein (3%).
Hepatic: increased alkaline phosphatase (6%), increased liver transaminases (4%), and hyperbilirubinemia (1%).
The clinician is advised to routinely perform urinalysis, blood chemistry profiles, and hematologic tests.
Read the Buphenyl (sodium phenylbutyrate tablets) Side Effects Center for a complete guide to possible side effects
Last reviewed on RxList: 11/12/2015
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