MRSA Treatment Dramatically Improved by FDA Approved Antibiotic?

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MRSA Methicillin-resistant Staphylococcus aureus Antibiotics FDA Infections
MRSA (Methicillin-resistant Staphylococcus aureus) treatment has a powerful ally in the form of a new antibiotic, dalvance, which has been proposed to dramatically improve treatment of the antibiotic-resistant bacterial skin infections that have become an global epidemic. The U.S. Food and Drug Administration (FDA) has approved the new drug in an effort to treat bacterial skin infections like MRSA and other antibiotic-resistant ‘superbugs’ that have become serious threats to the global community.

MRSA is caused by a strain of staph bacteria that become resistant to most antibiotics. It is a life-threatening infection and can often be found in hospitals and other health care settings. Dalvance is taken intravenously and has only been approved for use in adults. It is marketed by the Chicago-based company, Durata Therapeutics. Staph infections typically start with small red bumps, which could progress into painful abscesses that often require surgical draining.

The unique feature of dalvance, the newly approved antibiotic for MRSA treatment, is it will be the first drug labeled by the FDA as a Qualified Infectious Disease Product (QIDP). QIDP is part of a program the agency hopes will encourage drug companies to develop new drugs similar to dalvance that will be used to fight the global epidemic of antibiotic-resistant infections. Additionally, any drug designated as QIDP by the FDA gets a priority review and an expedited review process. Moreover, if approved, the drug also then qualifies for an additional five years of marketing exclusivity.

The new FDA approved antibiotic, dalvance, which has been proposed to dramatically improve treatment of MRSA and other antibiotic-resistant ‘superbugs’, could alter the medical landscape as we know it, if it proves to be as successful as predicted. According to a report released by the World Health Organization (WHO) in early 2014, antibiotic-resistant infections pose such a significant threat to human life that these infections could derail the “very achievements of modern medicine.” The report categorizes the problem as a global epidemic of epic proportions that a “post-antibiotic era” could become a very real possibility in the near future.

According to the Centers for Disease Control (CDC), antibiotic-resistant bacteria have infected more than two million people each year. At least 23,000 of those infected individuals die as a direct result of the infection and many more die as a result of complications resulting from that infection, mostly in hospital and health care settings. Additionally, it is estimated one in 25 hospital patients has at least one health care associated infection, including MRSA. Moreover, more than 200 people die from those infections every day. It has also been determined most infections happen to patients who are not in intensive care units (ICU). This unsettling finding means a patient could go into the hospital for a routine, low-risk surgery or procedure, and end up leaving the facility with a serious infection normal antibiotics will not be able treat effectively.

Medical experts have suggested the advent of MRSA and other antibiotic-resistant ‘superbugs’ stem from doctors who have over-prescribed antibiotics for decades. Patients who commonly went to their physicians for treatment of ordinary colds and flus were often given antibiotics, despite the fact that such infections rarely respond to medication. Over time, the bacteria that survived these treatments reproduced and were able to build an immunity to the prescribed antibiotics. As a result, infections became resistant to common antibiotics and became wider spread.

The latest FDA approved antibiotic, dalvance, which has been proposed to dramatically improve the global community’s odds in the fight to provide treatment for MRSA and other antibiotic-resistant ‘superbugs’, was approved after two clinical trials that included nearly 1,300 adults with this kind of infection. The adults were given Dalvance or another antibacterial drug, Vancomycin. Dalvance was found to be as effective as Vancomycin for the treatment of this infection and the dalvance could be administered in a single dose over a week period. While the vancomycin required two doses administered every day over a week period in order to achieve the same effect. The most common side effects experienced by individuals involved in the drug trial were nausea, headache, and diarrhea. Moreover, the percentage of those individuals affected by side effects were nominal.

By Leigh Haugh

Washington Post
Wall Street Journal
Boston Globe

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