| WASHINGTON
(Reuters Health) - A nationwide shortage of rattlesnake
antivenin (antidote to snake venom) is looming in the US,
after the US Food and Drug Administration (FDA) closed a
production facility belonging to Wyeth-Ayerst, the only
manufacturer of the product.
The
FDA closed the company's Marietta, Pennsylvania plant
due to quality control problems late last year. ``Portions
of that plant were closed for renovations in December,''
Wyeth spokesperson Doug Petkus told Reuters Health. This
is the same plant that produces Wydase, an absorption
enhancer of other drugs, which has resulted in a nationwide
shortage of that drug as well.
In
a July 12 letter to several hospitals, including the Hi-Desert
Medical Center (HDMC) in Joshua Tree, California, Wyeth
notified the centers of an anticipated shortage of the
antivenin.
The
stock of the product, Wyeth said, was being placed in
a controlled inventory and orders would be ``filled only
to end users on an emergency basis.'' The company added,
``It is likely there will be periods when product is unavailable,
including this year's period of peak usage.''
``It's
a nationwide problem,'' Deborah O'Connor of the HDMC,
told Reuters Health. The HDMC sees many rattlesnake bites
each year because it is located in an environment that
is ``rattlesnake heaven,'' Herman Galicia, Director of
HDMC's pharmacy, said.
``What
you're going to see is people suffering from the shortage,
if it continues,'' O'Connor said, because hospitals' supply
of antivenin can be exhausted just treating one patient.
Galicia
noted that the HDMC had only about 40 vials on hand, which
is more than any other center in the area but is only
enough to treat ``2 bites or 1 very, very serious one.''
However,
Wyeth's Petkus said, ``The controlled inventory seems
to be working efficiently and according to plan.''
In
addition to the southern part of California, rattlesnake
bites are seen frequently in Arizona, New Mexico, Texas,
Utah and the Midwest, O'Connor said.
Petkus
said he is ``not aware of any'' incidents in which the
company had to rush antivenin to a hospital for treatment
of a rattlesnake bite. But he noted that the company ``has
the ability to get the antivenin anywhere in a matter
of hours.''
Rose
Ann Soloway, associate director of the American Association
for Poison Control Centers, said that bite victims need
treatment immediately. ``A couple of hours'' may be okay,
she said, but ``24 hours is too long.''
The
HDMC has not seen any bites since the shortage was announced
and no centers ``have called me needing antivenin,'' Galicia
commented. He added that the peak season for rattlesnake
bites is past and that the HDMC generally does not see
any bites after September.
Soloway
said the biting season ``probably will extend to Fall,
but it really depends on the weather.'' If it gets cold,
the snakes become less active and consequently there are
fewer bites.
Normal
production of the antivenin should resume in ``the first
quarter of 2001,'' Petkus said.
The
FDA did not return phone calls from Reuters Health on
Monday.
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