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MEDSCAPE MEDICAL NEWS: FDA Approves New Antibiotic for Pneumonia, Skin Infections

Tue, Nov 2, 2010

Clinical News Room


The US Food and Drug Administration (FDA) yesterday gave clinicians a much-needed new weapon against tough bacterial infections by approving ceftaroline fosamil (Teflaro; Forest Laboratories) for treating community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin-structure infections (ABSSSI), including the notorious methicillin-resistant Staphylococcus aureus (MRSA).

Ceftaroline, an injectable antibiotic, is a cephalosporin, which counter bacteria by interfering with their cell walls.

The drug’s debut comes at a time when bacteria strains such as MRSA have gained resistance to existing antibiotics, leading to higher morbidity and mortality. MRSA, a common pathogen in ABSSSI, is resistant to not only methicillin, but also more common antibiotics such as amoxicillin and penicillin. Antibiotic resistance has complicated the treatment of CABP as well.

“These are serious and potentially life-threatening infections for which new treatment options are needed,” Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “FDA is committed to facilitating new antibiotic drug development.”

In September, the Anti-Infective Drugs Advisory Committee of the FDA unanimously endorsed ceftaroline as safe and effective for treating both CABP and ABSSSI, although some members felt that the evidence for the latter indication was less impressive.

Common adverse effects of the new antibiotic include diarrhea, nausea, and rash. Clinicians should not prescribe it for patients with sensitivities to cephalosporin antibiotics.

Medscape Medical News, October 30, 2010

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