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Drug Safety Communications - Volume 1, Number 1, Fall 2007

DateProduct(s)Safety Issue and Web Address
May 23, 2007Gadolinium-Containing Contrast Agents [ Magnevist (gadopentate dimeglumine), Omniscan (gadodiamide), OptiMARK (gadoversetamide), MultiHance (gadobenate dimeglumine), and Prohance (gadoteridol) ]Reports of nephrogenic systemic fibrosis (NSF)
May 21, 2007Avandia, Avandemet, and Avandaryl (rosiglitazone maleate)Pooled analysis of controlled clinical trials describing increased risks of heart attack and heart-related deaths
March 30, 2007Zelnorm1 (tegaserod maleate)Increased risk of heart attack, stroke and worsening heart chest pain
March 29, 2007Permax2 (pergolide mesylate)Increased risk of heart valve damage
March 16, 2007Zyvox (linezolid)Increased risk of death when used for intravascular catheter-related infections where there is a gram negative or no organism at time of study entry
March 9, 2007Erythropoiesis Stimulating Agents [ Aranesp (darbepoetin alfa), Epogen (epoetin alfa), Procrit (epoetin alfa) ]Increased risk of death, non-fatal heart attacks, strokes, heart failure, blood clots, and tumor progression
March 9, 2007Actimmune (Interferon gamma-1b)Early termination of clinical trial evaluating Actimmune for treatment of idiopathic pulmonary fibrosis (IPF) due to lack of benefit
February 21, 2007Xolair (omalizumab)Reports of delayed anaphylaxis
February 9, 2007Topical Anesthetic CreamsReports of life-threatening adverse events, such as an irregular heartbeat, seizures, and death


  1. Withdrawn from marketing March 30, 2007.
  2. Withdrawn from marketing March 29, 2007.


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