Well, as I expected and predicted in my previous post, the FDA did not waste much time approving ceftaroline (trade name – Teflaro) for complicated skin and skin structure infections (cSSSI). http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm231594.htm (thanks to Lee Rogers, DPM for forwarding me this link). What does this mean for those of us treating lower extremity infections? It is hard to say. As I discussed in my September 27 post, the clinical trials actually excluded diabetic foot infections (DFI) and decubitus ulcerations but still managed to include lower extremity infections as almost ½ of their cases. Because of this, I am guessing that Forest, the company marketing the drug, may be reluctant to call on us for fear that by doing so it may be perceived that they are de facto promoting DFI. I have seen this with other drugs. When Schering-Plough was selling Avelox (moxifloxacin, now with Merck) although it would be an excellent drug for DFI given the broad spectrum of activity including anaerobes, the company would not market to podiatric medicine for since they only had the cSSSI indication and not the DFI addition. I do not know any of the folks at Forest and do not know how aggressive they may be in their marketing campaign so this all remains up in the air. I am hoping that given the number of lower extremity infections that were included in their trial, they see the value in calling on those of us treating these infections.
Ceftaroline now becomes the 6th antibiotic FDA approved for the treatment of cSSSI caused by MRSA. It is the first cephalosporin with this indication which is both good and bad. It is good because it seems to have a typical cephalosporin safety profile, which is to say, very safe with only a few adverse events noted in the trials and nothing untoward was found. Most clinicians are really comfortable with this class of antibiotic. It is also broad spectrum including gram negatives but without Pseudomonas. Most of the other anti-MRSA drugs, with the exception of tigecycline, are pretty limited to gram positive cocci. The downside is that cephalosporins are not the “golden child” they once were. I know that my personal use has declined significantly. The greatest problem is that these drugs can lead to an increasing incidence of some of the new multi drug resistant gram negative rods including E. coli, P. mirablis and Klebsiella that produce “extended spectrum beta-lactamase” (ESBL) or Klebsiella pneumonae carbapenemase (KPC). Although usually found in sick patients in the ICU, I have started to see these cropping up in lower extremity infections. Heck, even Katie Couric did a piece on these new “Superbugs” on her evening news show.
The bottom line is that ceftaroline (Teflaro) should be a welcome new addition to treat mixed infections including those containing MRSA. Where it will pan out to treat lower extremity infections, and in particular DFI, and the attention Forest pays to those of us treating these infections, remains up in the air.