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U.S. Department of Health and Human Services

Drugs

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Drug Safety and Availability

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

 
Date Product(s) Safety Issue and Web Address
May 23, 2007 Gadolinium-Containing Contrast Agents [ Magnevist (gadopentate dimeglumine), Omniscan (gadodiamide), OptiMARK (gadoversetamide), MultiHance (gadobenate dimeglumine), and Prohance (gadoteridol) ] Reports of nephrogenic systemic fibrosis (NSF)
May 21, 2007 Avandia, Avandemet, and Avandaryl (rosiglitazone maleate) Pooled analysis of controlled clinical trials describing increased risks of heart attack and heart-related deaths
March 30, 2007 Zelnorm1 (tegaserod maleate) Increased risk of heart attack, stroke and worsening heart chest pain
March 29, 2007 Permax2 (pergolide mesylate) Increased risk of heart valve damage
March 16, 2007 Zyvox (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, 2007 Erythropoiesis 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, 2007 Actimmune (Interferon gamma-1b) Early termination of clinical trial evaluating Actimmune for treatment of idiopathic pulmonary fibrosis (IPF) due to lack of benefit
February 21, 2007 Xolair (omalizumab) Reports of delayed anaphylaxis
February 9, 2007 Topical Anesthetic Creams Reports of life-threatening adverse events, such as an irregular heartbeat, seizures, and death

Notes:

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 Withdrawn from marketing March 30, 2007.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 Withdrawn from marketing March 29, 2007.