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Strongyloides & Antiperistaltics & Citizen Petition to FDA

BeachSG beachsg at aol.com
Mon Apr 25 15:38:02 EST 1994

In June, 1992 I submitted a Citizen Petition to FDA Commissioner David A.
Kessler.  In that petition I asked Commissioner Kessler to order that the
labels on antiperistaltic drugs shall contain a warning about the danger of
administering antiperistaltics to people who are infected with threadworms
(Strongyloides stercoralis).  

My petition includes a reference to an article by Tommy C. Sim, M.D., et. al,
in which Dr. Sim wrote, "Drugs or metabolic derangements that contribute to
prolongation of gastrointestinal transit should be avoided since delayed fecal
elimination facilitates the transformation of rhabditiform to filariform larvae
and accelerates autoinfection" (Annals of Allergy, vol. 65, Sept. 1990, page

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." 

*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 92P-0270/CP1."

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

(916) 965-7083

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