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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