FDA considers revising criteria for ranking medically important antibiotics
The US Food and Drug Administration (FDA) late last week published a concept paper outlining potential revisions to criteria that the agency uses to guide the use of medically important antimicrobial drugs in veterinary medicine.
The FDA says the proposed approach for updating the current ranking of antibiotics, which was created in 2003 under Guidance for Industry (GFI) #152, would take into account an improved understanding of antimicrobial resistance, changes in human clinical practices, and other scientific advances. The revised criteria would also more broadly consider the importance of these antibiotics in human medicine, beyond their use in treating foodborne bacterial infections.
Under the current criteria, medically important antibiotics are ranked as critically important, highly important, or important for human medicine (a fourth category includes antibiotics not important for human medicine). The FDA uses these rankings to make decisions about how these antibiotics can be used in veterinary medicine, and to assess the antibiotic resistance risks involved. The approach outlined in the concept paper proposes categorizing antibiotics into three tiers—highest impact, intermediate impact, and lowest impact—that take into consideration the potential human health impact if resistance emerges to an antibiotic in one of these tiers.
"These revised criteria are intended to better characterize the overall importance of a drug for treating human infections, whether or not they are foodborne," the FDA said in a press release. "However, in addition to this importance ranking, other risk factors would be considered as part of an overall assessment of antimicrobial resistance risks associated with the use of an antimicrobial drug in animals."
The FDA is seeking comment on the concept paper and will hold a virtual meeting to discuss the details on Oct 16.
Oct 9 FDA press release
Oct 9 FDA concept paper
Flu-like illnesses linked to higher heart and stroke risk within the month
In a study last week in the Journal of the American Heart Association, researchers analyzing New York public health data from 2004 to 2015 found an association between flu-like illness and increased risk for heart attack and stroke in adults regardless of flu vaccine effectiveness (VE).
"We found that if someone's going to have a heart attack, it's going to occur within seven days of the flu-like illness, during the acute phase," study author Amelia Boehme, PhD, MSPH, says in an American Heart Association (AHA) press release. "With stroke, we see an increased risk seven to 15 days after, similar to heart attacks. But with stroke, there is an additional higher-risk period after 30 days."
Even though a higher VE correlated with lower rates of flu-like illnesses, stroke, and myocardial infarction (heart attacks) in adults, the association remained the same. Further research is needed to determine how and why the flu vaccine affects risk, the authors wrote.
A closer look at the study pool—which was between 5,639 and 57,993 cases per year—suggested that being above 65 years of years of age did not have any effect on the association between flu-like illness and stroke, but it did for heart attacks. Another subgrouping showed that while there was no significant relationship between stroke and race, there was one between heart attacks and non-black patients.
The researchers note that although they used billing codes and autoregressive integrated moving average models across the 10 years of data, their study is limited due to its ecological nature and it did not take into account variables such as individual vaccine usage and comorbidities such as high blood pressure and diabetes.
Oct 8 J Am Heart Assoc study
Oct 8 AHA press release
