Miles Pharmaceuticals has been licensed by the Food and Drug
Administration (FDA) to manufacture and distribute Niclocide
(Yomesan)** in the United States for treatment for humans with
cestodiasis (tapeworm infections). Drug requests should be
directed
to local Miles representatives or to: Miles Pharmaceuticals, 400
Morgan Lane, West Haven, CT 06516. Telephone: 800-243-4153 (toll
free) or 203-934-9221.
The Parasitic Disease Drug Service (PDDS) of CDC will continue
to
distribute 13 other drugs to physicians requesting them (Table 5).
After the requesting physician provides information about the
infection, specific laboratory data, and limited patient data
(name,
age, sex, and weight), CDC will release these drugs to all licensed
physicians in the United States who agree to register as Clinical
Investigators by completing FDA Form FD-1573. Included in each
shipment is a packet containing 1) a drug protocol outlining
indications/contraindications, dosages, routes and frequency of
administration, expected adverse reactions, and toxicity; 2) a
patient
consent form (available in English, Spanish, Cambodian, Lao, Muong
(Hmoob), and Vietnamese); and 3) a 1-page patient report form that
asks the physician to report all side effects of therapy and record
the drug's effectiveness (cure/noncure), as demonstrated by the
appropriate laboratory parameters.
Requests for drugs from PDDS should be directed to: Centers
for
Disease Control, Parasitic Disease Drug Service, 1600 Clifton Road,
Bldg. 6, Room 161, Atlanta, GA 30333. Telephone: (Day)
404-329-3670, 8:00 AM to 4:30 PM, Monday through Friday; (night,
weekend, or holiday) 404-329-2888, For Emergency Calls Only.
Reported by Parasitic Diseases Div, Center for Infectious Diseases,
CDC.
*Use of trade names is for identification only and does not imply
endorsement by the Public Health Service or the U.S. Department of
Health and Human Services.
**Formerly distributed in the United States by the Parasitic
Disease
Drug Service (PDDS) as niclosamide (Yomesan).
Disclaimer
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