March 5, 2009
 

Recalls and Safety Alerts: Higher Mortality for Certain Elderly Patients with Innohep


Recalls and Safety Alerts: Higher Mortality for Certain Elderly Patients with Innohep
Celgene is alerting healthcare professionals of an increased mortality risk among certain elderly patients treated with Innohep (tinzaparin sodium injection). Innohep is a low-molecular weight heparin that is used along with warfarin to treat acute ...
Source: www.accessdata.fda.gov

March 2009 Patient Safety News
Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients.
Source: www.fda.gov

CDER Organization Charts
CDER Organization Charts (updated)
Source: www.fda.gov

BPCA/Pediatric Exclusivity Statistics
BPCA/Pediatric Exclusivity Statistics (updated)
Source: www.fda.gov

Drug Safety Oversight Board Meetings
Memorandum of Meeting Minutes, Drug Safety Oversight Board Meeting, January 15, 2009
Source: www.fda.gov

Guidance for Industry
New Revised/Withdrawn List for 2009
Source: www.fda.gov

CellCept (mycophenolate mofetil)
Medication Guide issued, providing important safety information, to be distributed to every patient who fills a CellCept prescription from this point forward.
Source: www.fda.gov

Metoclopramide-Containing Drugs
Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken.
Source: www.fda.gov

Raptiva (efalizumab)
Public Health Advisory describes rare brain condition, progressive multifocal leukoencephalopathy, associated with the use of Raptiva.
Source: www.fda.gov

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