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fhea.com Fitzgerald Health Education Associates, Inc., May 2015
as safe and effective for their intended use to reduce
bacteria that potentially can cause disease.
The FDA noted that healthcare antiseptics are an
important component of infection control strategies
in hospitals, clinics, and other healthcare settings,
and include hand washes and rubs, surgical hand
scrubs and rubs, and patient preoperative skin prepa-
rations, including pre-injection preparations. The
most common active ingredients in healthcare anti-
septics marketed under the over-the-counter drug
monograph include alcohol and iodines, the FDA
states. These products are different from consumer
antiseptics, such as antibacterial soaps and hand san-
itizer rubs, which are not part of this proposed rule.
The FDA began reviewing healthcare antiseptics in
the 1970s; since then, many things have changed in-
cluding the frequency of use of some of these prod-
ucts, hospital infection control practices, new technol-
ogy that can detect low levels of antiseptics, the FDA's
safety standards, and scientific knowledge about the
impact of widespread antiseptic use. Emerging sci-
ence suggests that for at least some healthcare anti-
septic active ingredients, systemic exposure is higher
than previously thought. There are data that raise po-
tential concerns about the effect of repeated daily hu-
man exposure to some antiseptic active ingredients.
The agency is especially interested in data on long-
term safety of daily, repeated exposure to these ingre-
dients in certain populations, including pregnant and
breast-feeding healthcare workers.
For more information, click here:
FDA Warns SGLT2 Inhibitors for Diabetes
May Lead to Ketoacidosis
The FDA is warning that the type 2 diabetes medica-
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