FDA approves the first specific treatment for scorpion stings
Aug 3, 2011. The
U.S. Food and Drug Administration today approved Anascorp, the first
specific treatment for a scorpion sting by Centruroides scorpions in the
United States.
Venomous scorpions in the U.S. are mostly found in
Arizona. Severe stings occur most frequently in infants and children,
and can cause shortness of breath, fluid in the lungs, breathing
problems, excess saliva, blurred vision, slurred speech, trouble
swallowing, abnormal eye movements, muscle twitching, trouble walking,
and other uncoordinated muscle movements. Untreated cases can be fatal.
“This
product provides a new treatment for children and adults and is
designed specifically for scorpion stings,” said Karen Midthun, M.D.,
director of the FDA’s Center for Biologics Evaluation and Research.
“Scorpion stings can be life-threatening, especially in infants and
children.”
Anascorp, Centruroides (Scorpion) Immune F(ab’)2
(Equine) Injection, is made from the plasma of horses immunized with
scorpion venom. Anascorp may cause early or delayed allergic reactions
in people sensitive to horse proteins. The manufacturing process for
Anascorp includes steps to decrease the chance of allergic reactions and
to reduce the risk of transmission of viruses that may be present in
the plasma.
The effectiveness of Anascorp was based on results
from a randomized, double-blind, placebo-controlled trial of 15 children
with neurological signs of scorpion stings. These signs resolved within
four hours of treatment in the eight subjects who received Anascorp,
but in only one of the seven participants who received the placebo. The
most common side effects were vomiting, fever, rash, nausea, itchiness,
headache, runny nose, and muscle pain. In total, safety and efficacy
data was collected from 1,534 patients in both open-label and blinded
studies.
Anascorp was designated as an Orphan drug by FDA and
received priority review. It is licensed to Rare Disease Therapeutics
Inc., Franklin, TN, distributed by Accredo Health Group Inc., Memphis,
TN, and manufactured by Instituto Bioclon, S.A. de C.V., of Tlalpan,
Mexico, D.F.
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