Drotrecogin alfa (activated) (Xigris - Lilly), recombinant human activated protein C, has been approved by the FDA for treatment, in combination with standard therapy, of critically ill adults with severe sepsis and a high risk of death.

Since the last Medical Letter review of cephalosporin antibiotics (volume 25, page 57, 1983), many new cephalosporins have become available in the USA.

Belimumab (Benlysta – Human Genome Sciences/GlaxoSmithKline) has been approved by the FDA for treatment of adults with active, autoantibody-positive, systemic lupus erythematosus (SLE). It is the first biologic agent approved for SLE and the first drug of any kind to be approved for this disease in >50 years.

The FDA has announced that Eli Lilly has voluntarily withdrawn drotrecogin alfa (activated) (Xigris) after a recently completed trial (PROWESS-SHOCK) in patients with severe sepsis and septic shock failed to show an increase in survival in those treated with the drug.1 Drotrecogin alfa is a recombinant form of human activated protein C. Native activated protein C inhibits coagulation, increases fibrinolysis and has anti-inflammatory properties. FDA approval of Xigris (for patients with severe sepsis at high risk of death) was based on a single study (PROWESS).2 Post-marketing studies found a...

The FDA has approved a subcutaneously injected formulation of recombinant human parathyroid hormone (Natpara – NPS) as an adjunct to calcium and vitamin D to control hypocalcemia in adults with hypoparathyroidism. Natpara is an 84-amino acid single-chain polypeptide identical to native parathyroid hormone. It is the first parathyroid hormone formulation to be approved for this indication.

The FDA has approved cangrelor (Kengreal – The Medicines Company), an IV P2Y12 platelet inhibitor, as an adjunct to percutaneous coronary intervention (PCI) in patients who have not been pretreated with a P2Y12 inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.

Eravacycline (Xerava – Tetraphase), a new synthetic tetracycline antibiotic, has been approved by the FDA for IV treatment of complicated intra-abdominal infections (cIAIs) in adults. Eravacycline is structurally similar to tigecycline (Tygacil, and generics), a broad-spectrum tetracycline approved by the FDA for IV treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired pneumonia. A higher rate of mortality has been reported with use of tigecycline compared to other antibacterial drugs; it should be used only...

Aprotinin (Trasylol - Miles), an inhibitor of fibrinolysis first identified in 1930, was recently approved by the US Food and Drug Administration for intravenous use in high-risk coronary artery bypass graft (CABG) surgery to decrease bleeding and the need for transfusion. Inhibitors of fibrinolysis previously available in the USA include aminocaproic acid (Amicar, and others) and tranexamic acid (Cyklokapron - Medical Letter, 29:89, 1987).

Ofloxacin (Floxin - McNeil, Ortho), a new fluoroquinolone antibacterial agent, was recently marketed in the USA for oral treatment of various infections caused by susceptible microorganisms. Ofloxacin is the third fluoroquinolone to become available in this country. Norfloxacin (Noroxin - Medical Letter, 29:25, 1987) is marketed only for treatment of urinary tract infections. Ciprofloxacin (Cipro - Medical Letter, 30:11, 1988), like ofloxacin, is approved for use in a variety of infections.

Cefepime hydrochloride (Maxipime - Bristol-Myers Squibb), a new 'fourth-generation' cephalosporin, has been approved by the US Food and Drug Administration (FDA) for parenteral treatment of urinary tract infections and skin and skin-structure infections due to susceptible pathogens, and for moderate to severe pneunmonia caused by Streptococcus pneumoniae (pneumococci), Pseudomonas aeruginosa, Enterobacter or Klebsiella pneumoniae.