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.
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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)
Conclusions Our findings suggest a relatively unfavourable risk profile of sulphonylureas compared with metformin for all outcomes examined. Pioglitazone was associated with reduced all cause mortality compared with metformin. Pioglitazone also had a favourable risk profile compared with rosiglitazone; although this requires replication in other studies, it may have implications for prescribing within this class of drugs.
Preliminary analysis of data from a placebo-controlled study of sibutramine (Meridia) suggested an excess risk of cardiovascular events including myocardial infarction and cardiac death among patients taking the diet drug, according to the FDA.
Ziprasidone comes with a long list of precautions and contraindications:
* It should not be used in patients with a known history of QT prolongation, recent acute myocardial infarction, or uncompensated heart failure, and should not be used with other QT-prolonging drugs.
* It should also be avoided in elderly patients with dementia-related psychosis, as studies have shown that ziprasidone increases the risk of death in such patients.
* Discontinuation should be considered in patients showing signs of tardive dyskinesia.
* Treatment should be stopped immediately in patients with symptoms of neuroleptic malignant syndrome, which include hyperpyrexia, muscle rigidity, diaphoresis, tachycardia, irregular pulse or blood pressure, cardiac dysrhythmia, and altered mental status.
* Patients and clinicians should be alert for hyperglycemia, rash, seizures, and orthostatic hypotension with ziprasidone.
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