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.
NEJM — Weighing Risks and Benefits of Liraglutide — The FDA’s Review of a New Antidiabetic Therapy
On January 25, 2010, the FDA approved liraglutide, a glucagon-like-peptide-1 (GLP-1) receptor agonist that can be taken once daily to improve glycemic control in adults with type 2 diabetes.
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.
Overlapping use of tamoxifen and the antidepressant paroxetine (Paxil) significantly increases the risk of breast cancer mortality, data from a large cohort of breast cancer patients showed.
The excess breast-cancer mortality risk ranged as high as 91%, depending on the duration of simultaneous use, researchers reported online in BMJ.
Oops.
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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