Archive for the ‘FDA Alerts’ Category
New Safety Information for Tarceva (erlotinib)
May 9th, 2009 | 
Author: FDA MedWatch Alert
New Safety Information for Tarceva (erlotinib)
May 8, 2009
Audience: Oncological, dermatological and ophthalmological healthcare professionals.
OSI, Genentech and FDA notified healthcare professionals of new safety information added to the WARNINGS AND PRECAUTIONS sections of the prescribing information for Tarceva. Gastrointestinal perforation (including fatalities), bullous, blistering and exfoliative skin conditions including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, in some cases fatal, and ocular disorders…
FDA Approves Updated Labeling for Antiepileptic Drugs
FDA MedWatch Alert
FDA Approves Updated Labeling for Antiepileptic Drugs
May 5, 2009
Audience: Neuropsychiatric healthcare professionals, other healthcare professionals, patients.
Update: FDA notified healthcare professionals that it approved updated labeling for antiepileptic drugs used to treat epilepsy, psychiatric disorders, and other conditions (e.g., migraine and neuropathic pain syndromes). FDA also required development of a medication guide, to be issued to patients each time the product is dispensed.
Posted in FDA Alerts | 
Tags: antiepileptic drugs, epilepsy, FDA, FDA Alert, psychiatric disorders | 
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