Eye-Catching Labels Urged for Fast-Tracked Antibiotics
SUNDAY, March 2, 2014 -- 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.
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) news release.
In their letter to Congress last week, 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," the letter noted.
"Antibiotic resistance is a serious patient safety, public health and national security concern," the letter stated. 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," the letter said.
In 2011, one superbug, known as carbapenem-resistant Klebsiella pneumoniae, caused an outbreak at the Clinical Center of the U.S. National Institutes of Health, in which six people died within six months, according to the letter. Resistance rates for these and other resistant bacteria are on the rise, the letter added.
Although anyone could become infected with a drug-resistant superbug, the letter noted that 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, the letter said. The U.S. Department of Defense reports that roughly 3,300 service members treated in a military hospital between 2004 and 2009 were infected with a dangerous superbug known as Acinetobacter.
The U.S. Centers for Disease Control and Prevention has more about the dangers of antibiotic resistance.
Posted: March 2014