12 results match your criteria: "Center for Drug Evaluation and Review[Affiliation]"

In 2017, Opana ER was voluntarily removed from the U.S. market based on concerns that its risks outweighed its therapeutic benefits.

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Dosing Recommendations for Quetiapine When Coadministered With HIV Protease Inhibitors.

J Clin Pharmacol

April 2019

Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Review, Food and Drug Administration, Silver Spring, MD, USA.

Although current quetiapine labeling recommends that its dosage should be lowered 6-fold when coadministered with strong cytochrome P450 (CYP)3A inhibitors, a reported case of coma in a patient receiving quetiapine with lopinavir and ritonavir prompted the reevaluation of labeling recommendations for the dosing of quetiapine when coadministered with human immunodeficiency virus (HIV) protease inhibitors. Literature and database (FDA Adverse Event Reporting System and United States Symphony Health Solutions' Integrated Dataverse Database) searches allowed us to identify cases of coma and related adverse events involving the coadministration of quetiapine and HIV protease inhibitors and to estimate the frequency of concomitant use. Literature review and physiologically based pharmacokinetic modeling allowed us to estimate the potential for CYP3A inhibition to contribute to adverse events related to HIV protease inhibitor-quetiapine coadministration.

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TLRs as therapeutic targets in CNS inflammation and infection.

Front Biosci (Elite Ed)

June 2009

Laboratory of Immunology, Division of Therapeutic Proteins, Office of Biotechnology, Center for Drug Evaluation and Review, Food and Drug Administration, Bethesda, MD 20892, USA.

Far from being an immune-inert site, the cells of the CNS, including microglia, astrocytes and neurons, express an abundance of innate immune receptors, including toll like receptors (TLR), which recognize conserved structural motifs in pathogens. These TLRs have been implicated in both infectious and non-infectious CNS pathology and appear to play important roles in both tissue surveying and repair. Therapeutics that modulate their activity are being explored for the treatment of infectious and inflammatory diseases.

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Viral encephalitides are life-threatening diseases in neonates partly due to the irreversible damage inflammation causes to the CNS. This study explored the role of proinflammatory cytokines in the balance between controlling viral replication and eliciting pathologic immune responses in nonlytic viral encephalitis. We show that neonatal mice challenged with arenavirus Tacaribe (TCRV) develop a meningoencephalitis characterized by high IFN-gamma and TNF-alpha levels and mild T cell infiltration.

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Female's heightened immune status: estrogen, T cells, and inducible nitric oxide synthase in the balance.

Endocrinology

February 2006

Laboratory of Immunology, Division of Therapeutic Proteins, Center for Drug Evaluation and Review, Food and Drug Administration, Bethesda, Maryland 20892, USA.

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Oligodeoxynucleotides (ODN) containing CpG motifs mimic microbial DNA and are recognized by toll-like receptor 9 on immune cells. The resulting response limits the early spread of infectious organisms and promotes the development of adaptive immunity. In this regard, CpG ODN show promise as immunoprotective agents and as vaccine adjuvants.

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A survey of reports of quetiapine-associated hyperglycemia and diabetes mellitus.

J Clin Psychiatry

June 2004

Division of Metabolic and Endocrine Drug Products, Center for Drug Evaluation and Review, US Food and Drug Administration, Rockville, MD, USA.

Objective: To explore the clinical characteristics of hyperglycemia in patients treated with quetiapine.

Method: A pharmacovigilance survey of spontaneously reported adverse events in quetiapine-treated patients was conducted using reports from the U.S.

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Study Objective: To investigate the relative numbers and clinical characteristics of pancreatitis in patients treated with the atypical antipsychotic agents, clozapine, olanzapine, and risperidone, versus the conventional neuroleptic, haloperidol.

Design: Pharmacovigilance study of pooled, spontaneously reported adverse events.

Setting: Government-affiliated drug evaluation center.

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Olanzapine-associated diabetes mellitus.

Pharmacotherapy

July 2002

Division of Metabolic and Endocrine Drug Products, Center for Drug Evaluation and Review, Food and Drug Administration, Rockville, Maryland, USA.

Study Objective: To explore the clinical characteristics of hyperglycemia in patients treated with olanzapine.

Design: Retrospective, epidemiologic survey of spontaneously reported adverse events related to olanzapine therapy

Setting: Government-affiliated drug evaluation center.

Patients: Two hundred thirty-seven patients with olanzapine-associated diabetes or hyperglycemia.

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Commentary on 'Alpha calculus in clinical trials: considerations and commentary for the new millennium'.

Stat Med

March 2000

Food and Drug Administration, Center for Drug Evaluation and Review, Office of Biostatistics, 5600 Fishers Lane, Parklawn Building, Room 15B-45, Rockville, MD 20857, USA.

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