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| Drug Safety Communications |
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| 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:
- Withdrawn from marketing March 30, 2007.
- Withdrawn from marketing March 29, 2007.
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Drug Safety Communications
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