Will The FDA-Approved Ceftaroline Be Promoted To Podiatry?
As I expected and predicted in my previous blog, the FDA did not waste much time approving ceftaroline (Teflaro, Forest Laboratories) for complicated skin and skin structure infections (cSSSI). (See http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm231594.htm ).
What does this mean for those of us treating lower extremity infections? It is hard to say. As I discussed in my previous blog (see http://www.podiatrytoday.com/blogged/ceftaroline-new-agent-csssis ), the clinical trials actually excluded diabetic foot infections (DFI) and decubitus ulcerations, but still managed to include lower extremity infections as almost half of their cases. Due to 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 the company is de facto promoting use of the drug for DFIs.
I have seen this with other drugs. When Schering-Plough was selling moxifloxacin (Avelox, now marketed by Merck), although it would be an excellent drug for DFIs given the broad spectrum of activity including anaerobes, the company would not market to podiatric medicine since they only had the cSSSI indication and not the DFI indication. 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 the trial, they see the value in calling on those of us treating these infections.
Ceftaroline now becomes the sixth antibiotic approved by the FDA for the treatment of cSSSI caused by methicillin resistant Staphylococcus aureus (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 the drug is very safe. The trials noted only a few adverse events and found nothing untoward.
Most clinicians are really comfortable with this class of antibiotic. It also offers broad spectrum coverage, including gram negatives but without Pseudomonas. Most of the other anti-MRSA drugs, with the exception of tigecycline (Tygacil, Pfizer), 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 pneumoniae carbapenemase (KPC). Although these organisms are 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 The CBS Evening News.
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 in the armamentarium for treating lower extremity infections, in particular DFIs, and the attention Forest pays to those of us treating these infections remain up in the air.
Editor’s note: This blog was originally published at http://www.leinfections.com/category/antibiotics/ and has been adapted with permission from Warren Joseph, DPM, FIDSA, and Data Trace Publishing Company. For more information about the Handbook of Lower Extremity Infections, visit www.leinfections.com/ .