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 The guidance is part of the agency's ongoing efforts to protect
human cellular, tissue and blood products from potential
contamination with Zika virus, which has spread to at least 36
countries and territories, mostly in the Americas, since it appeared
in Brazil last year, according to the U.S. Centers for Disease
Control and Prevention (CDC).
"Though there is more to be learned about the transmission of Zika
virus, given what we know about the virus at this point, which also
is informed by our understanding of similar viruses, we must address
the potential risk of Zika virus transmission by human cells and
tissues," Peter Marks, director of the FDA’s Center for Biologics
Evaluation and Research, said in a statement.
Under the new recommendations, donors should be considered
ineligible if they were diagnosed with Zika virus infection or were
in an area with active virus transmission, or had sex with a male
with either of those risk factors, within the past six months, the
FDA said. (http://1.usa.gov/1WTMauz)
Deceased tissue donors should be considered ineligible if they were
diagnosed with Zika virus infection in the past six months. The
six-month period was selected due to limited data available on the
length of time the virus can persist in all tissues, the agency
said.
The list of potential donated human cellular and tissue products
includes corneas, bone, skin, heart valves, stem cells, as well as
amniotic membrane, placentas, umbilical cord blood and semen.
The disease is primarily spread by mosquitoes, but there is mounting
evidence that it can be transmitted through unprotected sex with an
infected person.
On Feb. 26, the CDC reported six confirmed and probable cases of
sexual transmission of the mosquito-borne Zika virus from male
travelers to affected areas to female non-travelers.
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U.S. health officials were initially investigating 14 reports of the
Zika virus that may have been sexually transmitted, including to
several pregnant women.
The World Health Organization last month declared the Zika outbreak
an international health emergency.
Much remains unknown about Zika, including whether the virus is
linked to thousands of potential cases in Brazil of the microcephaly
birth defect marked by undersized heads that can result in serious
brain deformities. Zika has not yet been definitively proven to be
the cause.
The number of confirmed and suspected cases of microcephaly in
Brazil associated with the Zika virus has risen to 4,863 from 4,690
a week earlier, the Ministry of Health said on Tuesday.
(Reporting by Bill Berkrot in New York and Ankur Banerjee in
Bengaluru; Editing by Sriraj Kalluvila, Bernard Orr)
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