lunes, 23 de noviembre de 2009

Care of the patient with aneurysmal subarachnoid hemorrhage.


GUIDELINE TITLE
Care of the patient with aneurysmal subarachnoid hemorrhage.

BIBLIOGRAPHIC SOURCE(S)
American Association of Neuroscience Nurses. Care of the patient with aneurysmal subarachnoid hemorrhage. Glenview (IL): American Association of Neuroscience Nurses; 2007. 30 p. [140 references]


GUIDELINE STATUS
This is the current release of the guideline.

** REGULATORY ALERT **
FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

December 16, 2008 - Antiepileptic drugs: The U.S. Food and Drug Administration (FDA) has completed its analysis of reports of suicidality (suicidal behavior or ideation [thoughts]) from placebo-controlled clinical trials of drugs used to treat epilepsy, psychiatric disorders, and other conditions. Based on the outcome of this review, FDA is requiring that all manufacturers of drugs in this class include a Warning in their labeling and develop a Medication Guide to be provided to patients prescribed these drugs to inform them of the risks of suicidal thoughts or actions. FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling change will be applied broadly.
December 3, 2008 - Innohep (tinzaparin): The U.S. Food and Drug Administration (FDA) has requested that the labeling for Innohep be revised to better describe overall study results which suggest that, when compared to unfractionated heparin, Innohep increases the risk of death for elderly patients (i.e., 70 years of age and older) with renal insufficiency. Healthcare professionals should consider the use of alternative treatments to Innohep when treating elderly patients over 70 years of age with renal insufficiency and deep vein thrombosis (DVT), pulmonary embolism (PE), or both.

abrir aquí para acceder al documento NGC AHRQ completo (muy extenso):
Care of the patient with aneurysmal subarachnoid hemorrhage.

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