Drugs
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Early 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. |
Early Communication About an Ongoing Safety Review: This type of communication is part of FDA's effort to communicate early with the public when the agency is still evaluating data and has not reached a conclusion. FDA shares information in the interest of informing doctors and patients about the issues that are under review and when FDA experts anticipate completing their review.
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2009
Early Communication about an Ongoing Safety Review of Meridia (sibutramine hydrochloride)
11/20/2009Early Communication about an Ongoing Safety Review of Deferasirox (marketed as Exjade)
9/25/2009Early Communication about an Ongoing Safety Review Orlistat (marketed as Alli and Xenical)
8/24/2009Early Communication about an Ongoing Safety Review of Omalizumab (marketed as Xolair)
7/16/2009Early Communication About Safety of Lantus (insulin glargine)
7/1/2009Early Communication about an Ongoing Safety Review Xigris (Drotrecogin alfa [activated])
2/4/2009Early Communication about an Ongoing Safety Review of clopidogrel bisulfate (marketed as Plavix)
1/26/2009
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2008
Early Communication about an Ongoing Safety Review of Epoetin Alfa
9/26/2008Early 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 (8/21/08)
8/21/2008Early Communication about an Ongoing Safety Review of Ziagen (Abacavir) and Videx (Didanosine)
7/24/2008Early Communication About an Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia)
6/4/2008Early Communication about an Ongoing Safety Review on Aprotinin Injection (marketed as Trasylol)
3/27/2008Early Communication About an Ongoing Safety Review of Montelukast (Singulair)
3/23/2008Early Communication about an Ongoing Safety Review of Tiotropium (marketed as Spiriva HandiHaler)
(3/18/2008; 10/7/2008)Early Communication about an Ongoing Safety Review of Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B)
2/8/2008Early Communication about an Ongoing Data Review for Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor)
1/25/2008
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2007
Early Communication About an Ongoing Safety Review of Varenicline (marketed as Chantix)
11/20/2007Early Communication About an Ongoing Safety Review of Cefepime (marketed as Maxipime)
11/14/2007Early Communication of an Ongoing Safety Review on Bisphosphonates: Alendronate (Fosamax, Fosamax Plus D), Etidronate (Didronel), Ibandronate (Boniva), Pamidronate (Aredia), Risedronate (Actonel, Actonel W/Calcium), Tiludronate (Skelid), and Zoledronic acid (Reclast, Zometa)
10/1/2007Early Communication About an Ongoing Safety Review of Omeprazole (Prilosec) and Esomeprazole (Nexium)
8/9/2007
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