It was difficult not to associate the Halloween weekend-approval of a new antibiotic by the FDA and the recent spate of news about the complications of oh, so many pharmaceuticals that were not reported during pre-approval trials. These findings, some deadly, came out after drugs had been out on the market for years. I am not saying that this is going to happen with this new antibiotic. As a person who is in the world of diabetic foot infections, I welcome wholeheartedly a new drug in the antibiotic armamentarium.
My only prayer here is that it is not OVERUSED so that it becomes yet another ineffective drug.
The FDA News Release tells us that this one is ceftaroline fosamil, or brand name Teflaro, an injectable cephalosporin antibiotic that will be used to treat adults with community acquired bacterial pneumonia (not by us!) and acute bacterial skin and skin structure infections, including methicillin-resistant Stephylococcus aureus or MRSA. Now you’re talking podiatry.
The FDA reports that “MRSA is a type of staph bacteria that is resistant to certain antibiotics. These antibiotics include methicillin and other more common antibiotics such as oxacillin, penicillin, and amoxicillin. In the community, most MRSA infections are skin infections. Severe or potentially life-threatening MRSA infections occur most frequently among patients in contact with health care settings, according to the Centers for Disease Control and Prevention.
“These are serious and potentially life-threatening infections for which new treatment options are needed,” said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research. “FDA is committed to facilitating new antibiotic drug development.”
“The safety and effectiveness of Teflaro was evaluated in four, Phase 3 clinical trials in patients ages 18 years and older (two each in CABP and in ABSSSI). In the CABP trials, the comparator antibacterial treatment was Rocephin (ceftriaxone) and in the ABSSSI trials, the comparator antibacterial treatment was Vancocin (vancomycin) plus Azactam (aztreonam).”
It appears to have been a well-designed protocol. “In the CABP trials, 1,231 adult patients received Teflaro or Rocephin. Clinical response based on improvement in signs and symptoms of pneumonia on Day 4 after starting therapy served as the key analysis endpoint. In both trials, the effectiveness of Teflaro was comparable to Rocephin.
“In the ABSSSI trials, 1,396 adult patients received Teflaro or Vancocin plus Azactam. Clinical response, including cessation of spread of the lesion and absence of fever on Day 3, served as the key analysis endpoint. In both trials, Teflaro was comparable to Vancocin plus Azactam.
“The most commonly reported side effects in patients treated with Teflaro included diarrhea, nausea and rash. Teflaro should not be used in patients with sensitivities to cephalosporin antibiotics.
“Teflaro is marketed by New York City-based Forest Laboratories,” whose coffers just grew in size exponentially upon this announcement! Who wouldn’t like to be the developer of a new MRSA antibiotic right now?
I just hope we don’t see a news release in a couple of years saying that some side effect was not announced to the public before it was released for wide use.