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U.S. Department of Health and Human Services


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Drug Safety and Availability

FDA Drug Safety Newsletter - Volume 1, Number 2, Winter 2008

This publication provides postmarketing information to healthcare professionals to enhance communication of new drug safety information, raise awareness of reported adverse events, and stimulate additional adverse event reporting.

In This Issue

Editor's Note

Postmarketing Reviews

Sildenafil citrate (marketed as VIAGRA and REVATIO), vardenafil hydrochloride (marketed as LEVITRA), and tadalafil (marketed as CIALIS): Sudden Hearing Loss

Infliximab (marketed as REMICADE), etanercept (marketed as ENBREL), and adalimumab (marketed as HUMIRA): Serious Skin Reactions

New Molecular Entity (NME) - 3 Years Later

Feature Article

Drug Safety Communications

picture of Winter 2008 Drug Safety Newsletter