FDA Drug Safety Newsletter

admin March 19th, 2008

The FDA’s Winter 2008 Drug Safety Newsletter has been published. Contents include:

Exenatide (marketed as BYETTA): Acute Pancreatitis

PHOSPHODIESTERASE TYPE 5 (PDE5) INHIBITORS: Sildenafil citrate (marketed as VIAGRA and REVATIO), vardenafil hydrochloride (marketed as LEVITRA), and tadalafil (marketed as CIALIS): Sudden Hearing Loss

TUMOR NECROSIS FACTOR ALPHA (TNF-α) ANTAGONISTS: Infliximab (marketed as REMICADE), etanercept (marketed as ENBREL), and adalimumab (marketed as HUMIRA): Serious Skin Reactions

New Molecular Entity (NME) – 3 Years Later: Duloxetine (marketed as CYMBALTA)

Feature Article: Pharmacogenomics and Its Role In Drug Safety

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