Re: Cytotec revisited

From: art fougner, md (evsono@pipeline.com)
Fri Dec 1 07:44:15 2000


despite this seal of approval, cytotec is still verboten at north shore - lij in new york - i guess another example of how lawyers can be hazardous to your health.

art

At Fri, 1 Dec 2000, Efrain Ramirez wrote: >
>ACOG NEWS RELEASE
>
> For Release: November 30, 2000
>
>ACOG Supports Use of Misoprostol for Medical Abortion and Labor
>Induction
>
>WASHINGTON, DC -- Two new committee opinions issued today by The
>American College of Obstetricians
>and Gynecologists (ACOG) affirm the use of the drug misoprostol for
>induction of labor and for medical abortion
>in combination with RU 486. ACOG also responds to a warning letter from
>the drug’s manufacturer that could
> affect women’s access to the drug.
>
>In Mifepristone for Medical Pregnancy Termination, ACOG concurs with the
>recent FDA decision that the
>drug mifepristone (RU 486) used in combination with misoprostol is
>appropriate for early medical abortion. The
>committee opinion advises ACOG’s 40,000 members that the drug
>combination "provides women with an
>effective and safe alternative to surgical abortion for very early
>intrauterine pregnancy termination."
>
>ACOG also supports some common off-label uses of misoprostol during
>labor and delivery in Response to
>Searle’s Drug Warning on Misoprostol. The ACOG document strongly
>reaffirms existing ACOG opinion that
>misoprostol -- a drug manufactured for treatment of gastric ulcers under
>the trade name CytotecÒ -- can be used
>safely and effectively off-label for cervical ripening and labor
>induction. ACOG is issuing the opinion in response
>to an August letter from G.D. Searle & Co., the manufacturer of
>misoprostol, which was sent to physicians just a
>few weeks before the FDA’s September approval of RU 486/misoprostol. The
>Searle letter cited safety concerns
>in advising against the use of misoprostol in pregnant women.
>
>After reviewing published data and adverse outcomes reported to the FDA,
>ACOG concludes that misoprostol
>when used appropriately is a safe and effective agent for cervical
>ripening and labor induction as well as a
>resource for treating serious postpartum hemorrhage. Expressing its
>concern about the "content, timing and tone"
>of the manufacturer’s letter, ACOG notes that the letter could limit the
>availability of misoprostol in women’s
> health care.
>
> ALSO FROM ACOG:
>
>Revised Recommendations on Colorectal Cancer Screening
>
>ACOG has updated two documents to reflect the latest recommendations on
>colorectal cancer screening. Revised
>committee opinions on Routine Cancer Screening and Primary and
>Preventive Care: Periodic Assessments now
>provide some testing options in routine colorectal cancer screening.
>Beginning at age 50, women should have a
>yearly fecal occult blood test plus one of the following: flexible
>sigmoidoscopy every 5 years; colonoscopy every
>10 years; or double contrast barium enema (DCBE) every 5 to 10 years. A
>digital rectal exam should also be
>performed at the time of each sigmoidoscopy, colonoscopy or DCBE.
>
>Routine screening should begin as early as age 19 for women considered
>at high risk for the disease. This includes
>women with a personal history of colorectal cancer, inflammatory bowel
>disease, or certain other conditions; or
>women with a family history of certain colorectal cancers or other
>conditions. Adolescent women who meet more
> stringent criteria also should be screened.
>
>ACOG also now recommends an annual flu vaccine for all women beginning
>at age 50. Previously, ACOG advised
>annual flu shots beginning at age 65. The change reflects the latest
>guidelines from the Centers for Disease Control
> and Prevention.
>
> New Manual on Quality Improvement
>
>ACOG has a newly revised manual for obstetrician-gynecologists managing
>their hospital department’s quality
>improvement program. Quality Improvement in Women’s Health Care
>provides information on developing a
>departmental quality assessment program, addresses issues in evaluating
>clinical competence, and provides
>screening tools for retrospective chart reviews of patient care. To
>order manuals, physicians or departmental staff
> can call (800) 762-2264.
>
> # # #
>
>Note to Editors: The following is the list of the new or revised ACOG
>documents discussed above.
>
> Committee Opinions
>
>Mifepristone for Medical Pregnancy Termination (December 2000)
>
>Primary and Preventive Care: Periodic Assessments (December 2000)
>
> Routine Cancer Screening (December 2000)
>
>Response to Searle’s Drug Warning on Misoprostol (December 2000)
>
> Manual
>
>Quality Improvement in Women’s Health Care (2000)
>
>The American College of Obstetricians and Gynecologists is the national
>medical organization representing over
>40,000 physicians who provide health care for women.
>
>--
>"Do not take life too seriously. You will never get out of it alive."
>
>Marianne Williamson
>

--
art fougner, md

A series of 1000 cases begins with but a single anecdote.





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