FDA MedWatch

Class 1 Recall due to complaints received about difficulty inserting the device used to place the tracheostomy tube into the windpipe (obturator), and/or a suction tube (catheter) into the tracheostomy tube.

Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides.

Public Health Advisory issued describing risk of skin burns during MRI scans.

Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients.

Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides.

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.

Treatment with zonisamide can cause metabolic acidosis in some patients.

Public Health Advisory describes rare brain condition, progressive multifocal leukoencephalopathy, associated with the use of Raptiva.

January 2009 Drug Safety Labeling Changes

Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book (updated)