Jan 28 The U.S. Food and Drug Administration
said on Tuesday it is working with the three manufacturers of
intravenous saline solutions commonly used to hydrate hospital
patients to address a shortage caused by a spike in demand.
Healthcare providers are reserving supplies of the fluids
for their most seriously ill patients, and the product
manufacturers - Baxter International Inc, Hospira Inc
and B. Braun Medical Inc - have stepped up production in
response, said Valerie Jensen, FDA's associate director for drug
"We have not heard of anyone running out of the IV solutions
at this point, but we know the hospitals are not comfortable
with the low supplies," Jensen said.
Manufacturers first notified FDA late last year that they
expected delays in filling orders, but an increase in
hospitalizations two weeks ago partly due to rising numbers of
flu cases exacerbated the problem, she said.
"The increase in demand pushed this into a shortage," Jensen
To cope with the shortage, healthcare providers are using
substitute products such as oral hydration fluids or smaller IV
saline bags with slower drip rates when appropriate, said Bona
Benjamin, director of medication use quality improvement for the
American Society of Health System Pharmacists.
"We have heard from our members all over the country that
the shortage is serious," Benjamin said. "People are able to
cobble together enough of a supply to get by day to day."
Baxter spokeswoman Deborah Spak said the company has
increased its production and is managing inventory to ensure
supplies for customers with the most urgent needs.
"Baxter has been manufacturing solutions at maximum capacity
in amounts exceeding those of prior years and is making
investments to further increase supply in 2014," Spak said.
Hospira said it is expediting shipments to help mitigate
local supply disruptions. "We are doing everything we can to
meet the increase in demand," said company spokesman Dan
Cathy Denning, a registered nurse with Novation, a supply
chain company that works with hospitals and other healthcare
providers, said it could be another two months before the
shortage is resolved.
FDA's Jensen said the agency is also looking into
alternative sources, including overseas suppliers, to help
address the shortage.