Eye-Catching Labels Urged for Fast-Tracked Antibiotics

Letter to Congress from medical groups focuses on 'superbug' threat.

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2014-03-03

More than 30 medical organizations and health experts are asking lawmakers on Capitol Hill to add a new, attention-grabbing label to certain antibiotics to prevent them from being prescribed inappropriately.

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To speed up the process by which new antibiotics are made available to people with serious or life-threatening drug-resistant infections, lawmakers introduced the Antibiotic Development to Advance Patient Treatment (ADAPT) Act last year.

This legislation will provide a pathway for new potentially life-saving drugs to be approved based on smaller clinical trials, as opposed to traditional large, clinical trials since drug-resistant infections affect a limited number of patients.

Although the drugs must still meet U.S. Food and Drug Administration standards for safety and effectiveness, they are intended for use in this limited and specific group of people, according to an Infectious Diseases Society of America (IDSA).

Health organizations -- including the American Medical Association, IDSA and Pew Charitable Trusts -- praised the legislation, while urging Congress to add a clearly visible logo or other image to the drugs' labels.

This logo would serve as an alert for health care professionals to remind them the medications are approved for a select group of patients and must be prescribed appropriately and with caution.

Unnecessary use of antibiotics may result in drug-resistant "superbugs.

Antibiotic resistance is a serious patient safety, public health and national security concern. It cited U.S. Centers for Disease Control and Prevention figures on the problem -- noting that more than 2 million people in the United States are infected with drug-resistant bacteria each year, and that 23,000 die as a result of their infection.

The real numbers are likely far higher, as our current surveillance and data collection capabilities cannot capture the full burden.

Although anyone could become infected with a drug-resistant superbug, certain people are at greater risk, including the following:

People with weakened immune systems, such as the elderly, people undergoing chemotherapy, people with HIV and those who've undergone an organ transplant.

Children, particularly premature infants and kids with special health care needs.

Women and men who have sex with men should be aware of drug-resistant Neisseria gonorrhoeae, the germ that causes gonorrhea. This sexually transmitted infection can make people more vulnerable to HIV infection. For women, this could also lead to an increase in pelvic inflammatory disease and infertility.

Soldiers with deep wounds or burns are also vulnerable to superbugs, which can result in amputations, blood infections and death.

Source: U.S. Dept. of Health & Human Services