Drugs
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Communications about Ongoing Safety Reviews
| As of January 29, 2010, FDA has transitioned to using one safety communication to provide the public with easy access to important drug safety information. These Drug Safety Communications have replaced Early Communications, Follow-Up Early Communications, Information for Healthcare Professional sheets, and Public Health Advisories. They are written in an easy-to-read, interactive format so that the public can access the information that is relevant to them. FDA has provided links on the new Drug Safety Communications page to the archived safety communications. |
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2009
Follow-Up to the August 2008 Early Communication About an Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia) - FDA Investigates a Report from the SEAS Trial
12/21/2009Follow-Up to the January 26, 2009, Early Communication about an Ongoing Safety Review of Clopidogrel Bisulfate (marketed as Plavix) and Omeprazole (marketed as Prilosec and Prilosec OTC)
11/17/2009Byetta Safety Update for Healthcare Professionals
11/9/2009Updated Information on Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR)
8/28/2009Follow-up to the June 4, 2008 Early Communication about the Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi)
8/4/2009Update of Safety Review of OnabotulinumtoxinA (marketed as Botox/Botox Cosmetic), AbobotulinumtoxinA (marketed as Dysport) and RimabotulinumtoxinB (marketed as Myobloc)
8/3/2009Cefepime (marketed as Maxipime) Safety Review: An Update
6/17/2009Updated Information on Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR)
6/12/2009Communication about an Ongoing Safety Review of Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder (ADHD)
6/23/2009; updated 4/2011Follow-up to the February 8, 2008, Early Communication about an Ongoing Safety Review of Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B)
4/2009Follow-up to the March 27, 2008 Communication about the Ongoing Safety Review of Montelukast (Singulair)
1/13/2009Follow-up to the January 25, 2008 Early Communication about an Ongoing Data Review for Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor)
1/8/2009
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2008
Communication about an Ongoing Safety Review of Innohep (tinzaparin sodium injection)
12/2/2008Update of Safety Review Follow-up to the October 1, 2007 Early Communication about the Ongoing Safety Review of Bisphosphonates
11/12/2008Follow Up to the January 3, 2008 Communication About an Ongoing Safety Review Erythropoiesis-Stimulating Agents (ESAs) Epoetin alfa (marketed as Procrit, Epogen) Darbepoetin alfa (marketed as Aranesp) 10/1/2008
10/1/2008Update of Safety Review: Follow-up to the March 27, 2008, Communication about the Ongoing Safety Review of Regranex (becaplermin)
6/6/2008Follow-up to the November 14, 2007, Communication about the Ongoing Safety Review of Cefepime (marketed as Maxipime): Update of Safety Review
5/14/2008Communication About an Ongoing Safety Review of CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid)
4/10/2008Communication about an Ongoing Safety Review of Regranex (becaplermin)
3/27/2008A Communication about an Ongoing Safety Review of Erythropoiesis-Stimulating Agents (ESAs) Epoetin alfa (marketed as Procrit, Epogen) Darbepoetin alfa (marketed as Aranesp)
1/3/2008
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