ANSWERS 06/13/1996 FIRST TREATMENT APPROVED FOR RARE PARASITIC INFECTIONS

T96-40                                       Ivy Fleischer Kupec
June 13, 1996                                (301) 443-3285


FIRST TREATMENT APPROVED FOR RARE PARASITIC INFECTIONS

     FDA has announced approval of the drug albendazole -- the
first approved medical treatment for two parasitic diseases:
neurocysticercosis and hydatid disease.  Approximately 300 U.S.
citizens are diagnosed with one of these diseases annually,
usually after having acquired the infection elsewhere.  The
following can be used to answer questions:
     Neurocysticercosis (NCC), which is caused by pork tapeworm
larvae, is considered the leading infectious cause of seizures
worldwide.  The disease is acquired when people consume tapeworm
eggs, usually through contaminated food or water.  These larvae
result in seizures and headaches when the disease involves brain
tissue.  Symptoms may not develop for five years or longer
following exposure.  In patients with active cysts, albendazole
has been found to be effective in 40 to 70 percent of cases. 
     Cystic hydatid disease causes enlarging parasitic cysts in
the liver, lungs, abdominal cavity, brain and/or bone.  These
cysts are slow-growing and may go undetected for years.  Symptoms
may be vague complaints of abdominal fullness or may be more
acute if the cyst ruptures.  The disease is acquired when people 
                             -More-                             Page 2, T96-40, Parasitic Infections
ingest dog tapeworm eggs through close contact with infected
dogs.  This tapeworm is exceedingly rare among dogs in the United
States.  Albendazole eliminates hydatid cysts in approximately 30
percent of patients and reduces their size in an additional 40
percent of patients.
     Adverse effects of the drug vary between NCC and hydatid
disease patients, but the most significant generally involve
diminished liver function and lower white blood cell counts.  In
NCC patients, the most common adverse effects are headache and
nausea/vomiting.  In patients with hydatid disease, the most
common adverse effects are abnormal liver function studies,
abdominal pain and nausea/vomiting.  
     Due to the low incidence of the disease, albendazole has
been designated as an "orphan" drug product. This designation
provides incentives for companies developing products for rare
diseases -- those affecting fewer than 200,000 people in the
United States and its territories.
     SmithKline Beecham Pharmaceuticals of Philadelphia, Pa.,
manufactures albendazole under the trade name Albenza.
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