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Antibiotic Resistant Infections : Part 2
by Food and Drug Administration (FDA)

(Page 2 of 3)

"There are the number of immunocompromised patients, who wouldn't have survived in earlier times," says Cranston. "Radical procedures produce patients who are in difficult shape in the hospital, and are prone to nosocomial [hospital-acquired] infections. Also, the general aging of patients who live longer, get sicker, and die slower contributes to the problem," he adds.

Though some people clearly need to be treated with antibiotics, many experts are concerned about the inappropriate use of these powerful drugs. "Many consumers have an expectation that when they're ill, antibiotics are the answer. They put pressure on the physician to prescribe them. Most of the time the illness is viral, and antibiotics are not the answer. This large burden of antibiotics is certainly selecting resistant bacteria," says Blum.

Another much-publicized concern is use of antibiotics in livestock, where the drugs are used in well animals to prevent disease, and the animals are later slaughtered for food. "If an animal gets a bacterial infection, growth is slowed and it doesn't put on weight as fast," says Joe Madden, Ph.D., strategic manager of microbiology at FDA's Center for Food Safety and Applied Nutrition. In addition, antibiotics are sometimes administered at low levels in feed for long durations to increase the rate of weight gain and improve the efficiency of converting animal feed to units of animal production.

FDA's Center for Veterinary Medicine limits the amount of antibiotic residue in poultry and other meats, and the U.S. Department of Agriculture monitors meats for drug residues. According to Margaret Miller, Ph.D., deputy division director at the Center for Veterinary Medicine, the residue limits for antimicrobial animal drugs are set low enough to ensure that the residues themselves do not select resistant bacteria in (human) gut flora.

FDA is investigating whether bacteria resistant to quinolone antibiotics can emerge in food animals and cause disease in humans. Although thorough cooking sharply reduces the likelihood of antibiotic-resistant bacteria surviving in a meat meal to infect a human, it could happen. Pathogens resistant to drugs other than fluoroquinolones have sporadically been reported to survive in a meat meal to infect a human. In 1983, for example, 18 people in four midwestern states developed multi-drug-resistant Salmonella food poisoning after eating beef from cows fed antibiotics. Eleven of the people were hospitalized, and one died.

A study conducted by Alain Cometta, M.D., and his colleagues at the Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland, and reported in the April 28, 1994, New England Journal of Medicine, showed that increase in antibiotic resistance parallels increase in antibiotic use in humans. They examined a large group of cancer patients given antibiotics called fluoroquinolones to prevent infection. The patients' white blood cell counts were very low as a result of their cancer treatment, leaving them open to infection.

Between 1983 and 1993, the percentage of such patients receiving antibiotics rose from 1.4 to 45. During those years, the researchers isolated Escherichia coli bacteria annually from the patients, and tested the microbes for resistance to five types of fluoroquinolones. Between 1983 and 1990, all 92 E. coli strains tested were easily killed by the antibiotics. But from 1991 to 1993, 11 of 40 tested strains (28 percent) were resistant to all five drugs.

Towards Solving the Problem

Antibiotic resistance is inevitable, say scientists, but there are measures we can take to slow it. Efforts are under way on several fronts — improving infection control, developing new antibiotics, and using drugs more appropriately.

Barbara E. Murray, M.D., of the University of Texas Medical School at Houston writes in the April 28, 1994, New England Journal of Medicine that simple improvements in public health measures can go a long way towards preventing infection. Such approaches include more frequent hand washing by health-care workers, quick identification and isolation of patients with drug-resistant infections, and improving sewage systems and water purity in developing nations.

Drug manufacturers are once again becoming interested in developing new antibiotics. These efforts have been spurred both by the appearance of new bacterial illnesses, such as Lyme disease and Legionnaire's disease, and resurgences of old foes, such as tuberculosis, due to drug resistance.

FDA is doing all it can to speed development and availability of new antibiotic drugs. "We can't identify new agents — that's the job of the pharmaceutical industry. But once they have identified a promising new drug for resistant infections, what we can do is to meet with the company very early and help design the development plan and clinical trials," says Blum.

In addition, drugs in development can be used for patients with multi-drug-resistant infections on an "emergency IND (compassionate use)" basis, if the physician requests this of FDA, Blum adds. This is done for people with AIDS or cancer, for example.

No one really has a good idea of the extent of antibiotic resistance, because it hasn't been monitored in a coordinated fashion. "Each hospital monitors its own resistance, but there is no good national system to test for antibiotic resistance," says Blum.

This may soon change. CDC is encouraging local health officials to track resistance data, and the World Health Organization has initiated a global computer database for physicians to report outbreaks of drug-resistant bacterial infections.

Experts agree that antibiotics should be restricted to patients who can truly benefit from them — that is, people with bacterial infections. Already this is being done in the hospital setting, where the routine use of antibiotics to prevent infection in certain surgical patients is being reexamined.

"We have known since way back in the antibiotic era that these drugs have been used inappropriately in surgical prophylaxis [preventing infections in surgical patients]. But there is more success [in limiting antibiotic use] in hospital settings, where guidelines are established, than in the more typical outpatient settings," says Cranston.

Murray points out an example of antibiotic prophylaxis in the outpatient setting — children with recurrent ear infections given extended antibiotic prescriptions to prevent future infections. (See "Protecting Little Pitchers' Ears" in the December 1994 FDA Consumer.)

Another problem with antibiotic use is that patients often stop taking the drug too soon, because symptoms improve. However, this merely encourages resistant microbes to proliferate. The infection returns a few weeks later, and this time a different drug must be used to treat it.

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www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.

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» Antibiotic Resistant Infections
» Part 2
» Part 3
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