The U.S. Food and Drug Administration (FDA) is requiring changes in the drug label for gadolinium-based contrast agents (GBCAs) to minimize the risk of nephrogenic systemic fibrosis (NSF), a rare, but serious, condition associated with the use of GBCAs in certain patients with kidney dysfunction.

New/Updated Drug Shortages: Calcium Chloride Injection (updated) 9/9/2010, NeoProfen (ibuprofen lysine) Injection (updated) 9/8/2010, Etoposide solution for injection (updated) 9/7/2010, Etoposide solution for injection 9/2/2010, Morphine Injection (2 mg, 4 mg, 8 mg, and 10 mg) (updated) 9/2/2010, Mitomycin for injection (updated) 9/2/2010, Mexiletine Capsules (150mg, 200mg, and 250mg) (updated) 9/2/2010, Leucovorin Calcium Lyophilized Powder for Injection (updated) 9/2/2010, Haloperidol Decanoate Injection (updated) 9/2/2010, Furosemide Injection 10mg/ml (updated) 9/2/2010, Epinephrine 0.1 mg/mL Emergency Syringes 10 mL LifeShield Abboject syringe with 1.5 inch, 21-gauge needle (NDC 00409-4921-34) (updated) 9/2/2010, Succinylcholine injection (updated) 9/2/2010, Atracurium injection (updated) 9/1/2010, Calcium Chloride Injection (updated) 9/1/2010, Cisplatin injection 1 mg/mL solution (updated) 9/1/2010, Dextrose 50% injection (updated) 9/1/2010, Fabrazyme (agalsidase beta) (updated) 9/1/2010, Technetium Tc99m Generators (updated)8/31/2010, Succinylcholine injection 8/25/2010, Morphine Injection (2 mg, 4 mg, 8 mg, and 10 mg) 8/20/2010, Cisplatin injection 1 mg/mL solution 8/18/2010, Technetium Tc99m Generators (updated) 8/16/2010, Naloxone Injection (updated) 8/16/2010, Vecuronium Injection (updated) 8/10/2010, Mitomycin for injection (updated) 8/10/2010, Haloperidol Decanoate Injection (updated) 8/10/2010, Furosemide Injection 10mg/ml (updated) 8/10/2010

News and Announcements updated

Data files updated through September 8, 2010.

Drug Approval Listing

Updated list.

Updated

Updated

The National Drug Code has been updated with data through September 1, 2010.

[09-01-2010] The U.S. Food and Drug Administration (FDA) is reminding healthcare professionals of an increased mortality risk associated with the use of the intravenous antibacterial Tygacil (tigecycline) compared to that of other drugs used to treat a variety of serious infections.

One new report (April to June 2010) and seven updated reports