Strongyloidiasis & Corticosteroids & Citizen Petition to FDA

BeachSG beachsg at aol.com
Tue Apr 5 21:37:04 EST 1994


An AIDS patient with gastrointestinal and pulmonary strongyloidiasis
(threadworm infection) was treated with a corticosteroid (see "Pulmonary
Strongyloidiasis: An Unusual Opportunistic Pneumonia in a Patient with AIDS,"
_American Journal of Roentgenology_, volume 161, number 3, pages 545-547). 
This treatment was not appropriate.  "Corticosteroid drugs should never be
administered to patients with strongyloidiasis, because such therapy results in
a fatal dissemination of the organism to all areas of the body"
(_Gastrointestinal Disease, Third Edition_, volume II, page 1007).

I have asked FDA Commissioner David A. Kessler to require that the labels on
corticosteroid drugs warn about the mortal danger of administering
corticosteroids to people who are infected with threadworms.  *Please write to
Dr. Kessler in support of my petition.*  Send letters to: Dockets Management
Branch, Food and Drug Administration, Department of Health and Human Services,
Room 4-62, 5600 Fishers Lane, Rockville, MD  20857.  In your letter, refer to
my Citizen Petition as "Docket Number 93P-0013/CP1." 

Section 10.30(d) of 21 Code of Federal Regulations Ch. I states: "An interested
person may submit written comments to the Dockets Management Branch on a filed
petition, which comments become part of the docket file.  The comments are to
specify the docket number of the petition and may support or oppose the
petition in whole or in part.  A request for alternative or different
administrative action must be submitted as a separate petition." 

Scott G. Beach
8185 Walnut Fair Circle
Fair Oaks, CA  95628-2743

(916) 965-7083



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