As multidrug-resistant infections have grown more prevalent, few new antibiotics are reaching the market. This is attributed, in part, to the economic and regulatory challenges associated with their development. Recently, stakeholders have endorsed a novel regulatory pathway to approve these lifesaving drugs for use in limited patient populations — namely those at highest risk and with few or no other options.More info
Staphylococcus aureus, or staph, is a common bacterium that exists in our environment and our bodies. Most of the time it does no harm. Sometimes, however, it can cause infection and require treatment. MRSA refers to strains of S. aureus that are resistant to the antibiotic methicillin and a host of other drugs used to treat infection.
• MRSA is responsible for an estimated 19,000 U.S. deaths1 and 368,000 hospitalizations per year.2
• Patients with MRSA can be twice as likely to die as patients with staph infections that can be treated with methicillin.3
• Annual costs of treating hospitalized MRSA patients are between $3.2 billion and $4.2 billion in the United States.4
MRSA Is Becoming Resistant to a Growing Number of Antibiotics
MRSA is most commonly resistant to antibiotics used to treat conventional staph infections.7
• Beta-lactams (penicillins and cephalosporins)
• Fluoroquinolones (e.g., levofloxacin)
• Macrolides (e.g., erythromycin, azithromycin)
MRSA can usually be treated with “last-resort” antibiotics, but some resistance has been reported to:8
• Linezolid and daptomycin11,12 (the last two novel drugs approved to treat drug-resistant S. aureus infections).
- Date added:
- Apr 3, 2012
- Antibiotics and Innovation Project
- Food Safety, Antibiotic Innovation
- Collapse All
2 Agency for Healthcare Research and Quality (AHRQ), Center for Delivery Organization, and Markets, Healthcare Costs and Utilization Project, Nationwide Inpatient Sample, 1993-2005.
3 M. Whitby, M.L. McLaws, and G. Berry. “Risk of death from methicillin-resistant Staphylococcus aureus bacteraemia: a meta-analysis,” Med J Aust 175, no. 5 (2001):264-7.
4 E. Rojas and L. Liu, “Estimating the annual hospital excess cost of methicillin-resistant Staphylococcus aureus infections in the United States,” presented at International Society for Pharmacoeconomics and Outcomes Research (IPSOR) Tenth Annual International Meeting, Washington, DC, May 2005.
5 H. Boucher, L. G. Miller, and R. R. Razonable, “Serious Infections Caused by Methicillin-Resistant Staphylococcus Aureus,” Clin Infect Dis 51 Suppl 2(2010): S183-97.
6 A. Elixhauser and C. Steiner, “Infections with Methicillin-Resistant Staphylococcus Aureus (MRSA) in U.S. Hospitals, 1993–2005,” HCUP Statistical Brief #35. July 2007. Agency for Healthcare Research and Quality, Rockville, MD. www.hcup-us.ahrq.gov/reports/statbriefs/sb35.pdf.
7 K. Chua et al., “Antimicrobial Resistance: Not Community-Associated Methicillin-Resistant Staphylococcus Aureus (CA-MRSA)! A Clinician’s Guide to Community MRSA — Its Evolving Antimicrobial Resistance and Implications for Therapy,” Clin Infect Dis 52, no. 1 (2011): 99-114.
8 C. Liu et al., “Clinical Practice Guidelines by the Infectious Diseases Society of America for the Treatment of Methicillin-Resistant Staphylococcus Aureus Infections in Adults and Children,“ Clin Infect Dis 52, no. 3 (2011): e18-55.
9 L. L. Han et al., “High Frequencies of Clindamycin and Tetracycline Resistance in Methicillin-Resistant Staphylococcus Aureus Pulsed-Field Type Usa300 Isolates Collected at a Boston Ambulatory Health Center,” J Clin Microbiol 45, no. 4 (2007): 1350-2.
10 R. E. Mendes et al., “Characterization of Baseline Methicillin-Resistant Staphylococcus Aureus Isolates Recovered from Phase Iv Clinical Trial for Linezolid,” J Clin Microbiol 48, no. 2 (2010): 568-74.
11 A. Mangili et al., “Daptomycin-Resistant, Methicillin-Resistant Staphylococcus Aureus Bacteremia,” Clin Infect Dis 40, no. 7 (2005): 1058-60.
12 P. Wilson et al., “Linezolid Resistance in Clinical Isolates of Staphylococcus Aureus,” J Antimicrob Chemother 51, no. 1 (2003): 186-8.
In January 2011, President Barack Obama signed the FDA Food Safety Modernization Act (FSMA) into law, signaling the first major update to our nation’s food safety oversight framework since the Great Depression. Despite widespread support for the legislation and its implementation, the Obama administration still has not issued all of the proposed rules under FSMA.More info
"The Food and Drug Administration will not reduce food inspections because of budget cuts, despite warning earlier that it could be forced to eliminate thousands of inspections by Sept. 30."More info
"As a nation, we need to exercise greater care with our use of antibiotics, in both humans and animals, so that these medications remain effective in treating serious bacterial infections."More info
"Twenty-two weeks. That’s how long it took federal health officials to determine the contaminated food source after the first person was infected in a 2011 outbreak of salmonella that swept across 34 states, sickened 136 people and led to one of the largest national recalls of ground turkey."More info