Five of 22 serious AEs were felt by the investigator to be due to tocilizumab treatment. These were benign intracranial hypertension, cellulitis, pneumonia, urinary calculus and uveitis. Laboratory abnormalities included alanine aminotransferase elevations greater than three times the upper limit of normal (ULN; 4%), aspartate aminotransferase elevations >3× the ULN (0.5%), neutropenia (4%) and thrombocytopenia (1%). Low-density lipoprotein cholesterol levels ≥110 mg/dL were noted in 11% of patients and total cholesterol levels ≥170 mg/dL were noted in 35% of patients. One patient discontinued therapy for lack of efficacy. This patient had a positive anti-tocilizumab antibody result without an anaphylactic reaction.
The European Commission (EC) has approved tocilizumab (RoACTEMRA) for treating moderate-to-severe RA in patients who are either intolerant to, or have failed to respond to, other RA treatments.5
Drug Safety
The risk of progressive multifocal leukoencephalopathy (PML) in patients with systemic lupus erythematosus has been added to the Warnings, Precautions and Serious Infections section of the belimumab (Benlysta) package labeling, as well as to the Patient Medication Guide and Patient Advice sections.6
Eszopiclone (Lunesta) has been reported to cause next-day impairment of activities requiring mental alertness.7 A double-blind study evaluated psychomotor function in healthy adults (ages 25–40 years; n=91) who had received the initially recommended 3 mg eszopiclone dose. Psychomotor coordination included driving impairment, tests of working memory and subjective assessment of coordination and sedation. Compared with placebo-treated patients, subjects who received eszopiclone 3 mg at bedtime had next-morning psychomotor and memory impairment, which was clinically meaningful at 11.5 hours and most severe at 7.5 hours. Additionally, patients were often not aware that they were impaired. The new, lower recommended starting dose is 1 mg at bedtime for both men and women, as they appear equally predisposed. All labeling has been updated by the Food and Drug Administration. Any new information will be reported on this AE when available.
The occurrence of hypocalcemia has been added to the Warnings and Precautions section of the zoledronic acid (Zometa) labeling.6 Cardiac arrhythmias and neurologic AEs including tetany, seizures and numbness have been reported to have occurred secondary to severe hypocalcemia cases. Some of these cases may be life threatening. The labeling recommends that hypocalcemia be corrected prior to initiating zoledronic acid. Patients need to be adequately supplemented with calcium and vitamin D. Additionally, an acute phase reaction consisting of arthritis with subsequent joint swelling has occurred; this has also been added to the Postmarketing AE Experience section of the product labeling.
