From: llscottmd@aol.com
Sent: Wednesday, January 03, 2001 6:58 PM
To: fdadockets@oc.fda.gov
Subject: Physician Letter to FDA regarding Misoprostol

FROM:

NAME:		Laurie Scott
ADDRESS:	580 NW 108th Ave
		Plantation, FL 33324


Dear :
Searle's action has the potential to limit access to a drug that my colleagues
and I use for managing deliveries.  

Misoprostol has been used for many years to induce labor in women ready, but
unable to deliver healthy babies without assistance.  In these cases,
misoprostol helps ensure the delivery of health babies and helps ensure the
health and the life of the mother, both by bringing the pregnancy to a safe
conclusion and by helping to treat post-delivery hemorrhaging.	The obstetrical
research literature is replete with articles that demonstrate the safety and
effectiveness of this drug for use as an induction agent. It would be a major
step backwards in the ability to safely induce labor if misoprostol was not
available for this purpose.  Although the drug may be legally available for
this purpose, Searle's letter has influenced many hospitals to ban the use of
misoprostol for inductions and certainly increases the likelihood of frivolous
lawsuits against physicians who appropriately use this drug. 

Additionally any contraindications for use of misoprostol in pregnancy that are
not warranted by scientific evidence should be rescinded.  Although Searle
correctly points out the potentially serious, but relatively rare risks of
misoprostol, it fails to comment on the extensive clinical experience with this
agent and the large body of published reports supporting its safety and
efficacy when used appropriately, according to ACOG's Committee on Obstetric
Practice.  

Sincerely, 

Laurie Scott, MD