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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 2, Number 3, 2009

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

Postmarket Reviews

Reports of secondary exposure of children to testosterone gel products (marketed as AndroGel 1% and Testim 1%) 

Reports of serious cardiopulmonary adverse events in neonates associated with precipitation of ceftriaxone (marketed as Rocephin and generics) and calcium salt in the body

Reports of loss of sense of smell associated with the use of zinc-containing intranasal cold products (marketed as Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size)

Drug Safety Oversight Board 

Quarterly summary of each board meeting with related links

Drug Safety Communications

List of drug safety advisories posted on FDA’s Web site from April 1, 2009, to July 1, 2009, with related links

 Newsletter Cover - doctor, baby, table to contents