Should New Estrogen Carry Warning in Labeling?

By Portyansky, Elena | Drug Topics, March 2, 1998 | Go to article overview

Should New Estrogen Carry Warning in Labeling?


Portyansky, Elena, Drug Topics


Almost flawless in its way of targeting some tissues while leaving others alone, Evista (raloxifene), the first designer estrogen to emerge for the prevention of osteoporosis in postmenopausal women, has been widely embraced. But there is one exception-Samuel Epstein, M.D., chairman of the Cancer Prevention Coalition and professor of environmental medicine at the University of Illinois. After reviewing raloxifene's data, he came across carcinogenesis studies conducted by raloxifene's manufacturer (Eli Lilly), which he feels warrant a warning to women-at the very least.

In the 21-month study, female rodents exposed to various doses of the selective estrogen receptor modulator (SERM) were found to have an increased incidence of ovarian tumors. Systemic exposure (AUC) of raloxifene in the animals ranged from 0.3 to 34 times that found in postmenopausal women administered a therapeutic dose of 60 mg.

The study concluded that the clinical relevance of these tumor findings is unknown. Epstein doesn't agree and voiced his viewpoint on the Jan. 12 "Jim Lehrer Newshour" on public television. He believes these results create a strong presumption of human risk of ovarian cancer, since carcinogenic effects occurred in two animal species and at doses extending below the therapeutic range. He is outraged that raloxifene's manufacturer failed to disclose a notice to that effect in its warning section of product labeling. This drug, Epstein continued, "should be withdrawn from the world market immediately, and a cancer alert should be sent to the more than 12,000 women who have participated in U.S. and international clinical trials. These women should also be offered lifelong biannual surveillance for the early detection of ovarian cancer at Lilly's expense."

Willard Dere, M.D., director, medical (endocrine research), Eli Lilly, countered that the observations seen in the reproductive-age rodents are not applicable to, or predictive of, what occurs in postmenopausal women, since the subjects' hormonal backdrops differ. …

The rest of this article is only available to active members of Questia

Sign up now for a free, 1-day trial and receive full access to:

  • Questia's entire collection
  • Automatic bibliography creation
  • More helpful research tools like notes, citations, and highlights
  • Ad-free environment

Already a member? Log in now.

Notes for this article

Add a new note
If you are trying to select text to create highlights or citations, remember that you must now click or tap on the first word, and then click or tap on the last word.
One moment ...
Default project is now your active project.
Project items

Items saved from this article

This article has been saved
Highlights (0)
Some of your highlights are legacy items.

Highlights saved before July 30, 2012 will not be displayed on their respective source pages.

You can easily re-create the highlights by opening the book page or article, selecting the text, and clicking “Highlight.”

Citations (0)
Some of your citations are legacy items.

Any citation created before July 30, 2012 will labeled as a “Cited page.” New citations will be saved as cited passages, pages or articles.

We also added the ability to view new citations from your projects or the book or article where you created them.

Notes (0)
Bookmarks (0)

You have no saved items from this article

Project items include:
  • Saved book/article
  • Highlights
  • Quotes/citations
  • Notes
  • Bookmarks
Notes
Cite this article

Cited article

Style
Citations are available only to our active members.
Sign up now to cite pages or passages in MLA, APA and Chicago citation styles.

(Einhorn, 1992, p. 25)

(Einhorn 25)

1

1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

Cited article

Should New Estrogen Carry Warning in Labeling?
Settings

Settings

Typeface
Text size Smaller Larger Reset View mode
Search within

Search within this article

Look up

Look up a word

  • Dictionary
  • Thesaurus
Please submit a word or phrase above.
Print this page

Print this page

Why can't I print more than one page at a time?

Full screen

matching results for page

Cited passage

Style
Citations are available only to our active members.
Sign up now to cite pages or passages in MLA, APA and Chicago citation styles.

"Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn, 1992, p. 25).

"Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn 25)

"Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences."1

1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

Cited passage

Welcome to the new Questia Reader

The Questia Reader has been updated to provide you with an even better online reading experience.  It is now 100% Responsive, which means you can read our books and articles on any sized device you wish.  All of your favorite tools like notes, highlights, and citations are still here, but the way you select text has been updated to be easier to use, especially on touchscreen devices.  Here's how:

1. Click or tap the first word you want to select.
2. Click or tap the last word you want to select.

OK, got it!

Thanks for trying Questia!

Please continue trying out our research tools, but please note, full functionality is available only to our active members.

Your work will be lost once you leave this Web page.

For full access in an ad-free environment, sign up now for a FREE, 1-day trial.

Already a member? Log in now.