Coumadin 1 mg tablet blister packs recalled
Bristol-Myers Squibb has announced a voluntary recall of three lots of physician sample blister packs of Coumadin 1 mg tablets and five lots of Coumadin 1 mg tablet hospital unit dose blister packs. According to the FDA, this recall does not involve Coumadin 1 mg supplied in bottles or any other strengths and dosage forms of the product.
The manufacturer has not received any reports of adverse events, but issued the recall as a precautionary measure based on its determination that some of the tablets, over time, may not meet specifications for isopropanol. Isopropanol is used to maintain the active ingredient, Coumadin, in the crystalline state and could affect the therapeutic levels of the active ingredient.
The following lot numbers are included in this recall:
Physician sample blister packs: Lot# 9A48931A, 9A48931B, 9A48931C, expiration January 2012.
Hospital unit dose blister packs: Lot# 8F34006B, 8K44272A, 8K46168A, 9F44437A and 9K58012B with expiry dates between June 2011 and November 2012.
Any adverse reactions may also be reported to the FDA’s MedWatch Program.
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Title: Safety and Efficacy of Sertraline for Depression in Patients With Heart Failure: Results of the SADHART-CHF (Sertraline Against Depression and Heart Disease in Chronic Heart Failure) Trial
Date Posted: August 18, 2010
Authors: O’Connor CM, Jiang W, Kuchibhartla M, et al.
Citation: J Am Coll Cardiol 2010;56:692-699.
Study Question:
Is sertraline effective for treatment of depression in patients with heart failure?
Methods:
The Sertraline Against Depression and Heart Disease in Chronic Heart Failure (SADHART-CHF) study was a randomized, double-blind, controlled trial comparing sertraline 50 to 200 mg/day to matching placebo among heart failure patients. Subjects were 45 years or older with a left ventricular ejection fraction ≤45% and New York Heart Association functional class II-IV. Clinical major depression was diagnosed by the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition criteria. Patients with significant cognitive impairment, psychosis, recent alcohol or drug dependence, bipolar or severe personality disorder, active suicidal ideation, and current antipsychotic or antidepressant medication use were excluded. Both treatment arms received nurse-facilitated support. Primary outcomes of interest were change in depression severity measured by the Hamilton Depression Rating Scale total score and composite cardiovascular status at 12 weeks.
Results:
A total of 469 patients were included in the study (234 randomized to sertraline and 235 randomized to placebo). The mean ± SE change in depression score from baseline to 12 weeks was –7.1 ± 0.5 for those in the sertraline groups and –6.8 ± 0.5 for those in the placebo group. The difference between groups was not significant (p = 0.89). The proportion of subjects whose composite cardiovascular score worsened, improved, or was unchanged were 29.9%, 40.6%, and 29.5%, respectively for the sertraline group and 31.1%, 43.8%, and 25.1%, respectively in the placebo group. These proportions were similar between the two groups (p = 0.078).
Conclusions:
The investigators concluded that sertraline was safe for use in heart failure patients with depression; however, reduction in depression compared with the control group was not statistically different. Improved cardiovascular status was also similar between patients randomized to sertraline, as compared to placebo.
Perspective:
Depression among patients with heart failure is an important concern for clinicians. It is likely that the nonsignificant difference between the intervention (i.e., sertraline) and control groups was in part due to the nurse-facilitated support provided to both groups in addition to the types of patients who would enroll in such a study, less severe depression, and dosing of sertraline.
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