From April 2005 to October 2008, FDA received 78 reports of altered kidney function in patients treated with Byetta. Some of the patients had pre-existing kidney disease and other risk factors for developing kidney problems. Acute renal failure occurred in 62 patients and renal insufficiency in 16 patients.
The Associated Press: Pfizer Alzheimer’s disease drug fails in study
The Boomers are aging and Alzheimer’s incidence is expected to increase. This is disappointing news.
Conclusions In this large, population based study, the use of venlafaxine was not associated with an excess risk of sudden cardiac death or near death compared with fluoxetine, dosulepin, or citalopram, in patients with depression or anxiety.
RESULTS There were 160 deaths (24.6%) during follow-up, with 70 (43.8%) due to CVD. In Kaplan-Meier survival analysis, there was no difference in either CVD or all-cause mortality in aspirin users versus nonusers (P = 0.52 and 0.94, respectively, by log-rank test). After adjustment for significant variables in the most parsimonious Cox models, regular aspirin use at baseline independently predicted reduced CVD and all-cause mortality (hazard ratio [HR] 0.30 [95% CI 0.09–0.95] and 0.53 [0.28–0.98[, respectively; P ≤ 0.044). In subgroup analyses, aspirin use was independently associated with reduced all-cause mortality in those aged ≥65 years and men.
CONCLUSIONS Regular low-dose aspirin may reduce all-cause and CVD mortality in a primary prevention setting in type 2 diabetes. All-cause mortality reductions are greatest in men and in those aged ≥65 years. The present observational data support recommendations that aspirin should be used in primary CVD prevention in all but the lowest risk patients.
A warning of a risk of progressive multifocal leukoencephalopathy has been added to the label for the multiple sclerosis drug natalizumab (Tysabri), the FDA announced. The labeling change was prompted by continuing reports of PML in MS patients. The current number of confirmed cases stands at 31 — 10 in the U.S. — up from 13 as recently as last September.
Byetta (exenatide) – Renal Failure
From April 2005 through October 2008, FDA received 78 cases of altered kidney function (62 cases of acute renal failure and 16 cases of renal insufficiency), in patients using Byetta. Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems.
Oops.Oops.
Sibutramine is not to be used in patients with a history of cardiovascular disease, including:
* History of coronary artery disease (e.g., heart attack, angina)
* History of stroke or transient ischemic attack (TIA)
* History of heart arrhythmias
* History of congestive heart failure
* History of peripheral arterial disease
* Uncontrolled hypertension (e.g., > 145/90 mmHg)
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