Diethylstilbestrol Contraindicated in Pregnancy

image of the FDA-building
Considering the risks and the numerous studies showing DiEthylStilbestrol inefficiency and harm, it is unbelievable that the FDA never banned the use of DES during pregnancy.

Abstract

Diethylstilbestrol Contraindicated in Pregnancy: Drug’s Use Linked to Adenocarcinoma in the Offspring

Selected Item from the FDA Drug Bulletin, November 1971, National Institutes of Health, PMCID: PMC1518220.

” WE WISH TO BRING to the attention of all physicians, hospitals, and medical personnel an important possible toxic effect of diethylstilbestrol (DES) reported for the first time in April 1971 by Herbst et al. From their studies the authors concluded that maternal ingestion of diethylstilbestrol during pregnancy appears to increase the risk of vaginal adenocarcinoma developing years later in the offspring exposed. The authors studied eight cases of adenocarcinoma of the vagina in patients born between 1946 and 1951. The malignancies were identified and treated between 1966 and 1969. In seven of the eight cases, there was a history -of maternal use of diethylstilbestrol. Because this type of malignancy in young girls had rarely been reported previously, the authors conducted a retrospective investigation in an attempt to find factors that may be associated with such malignancy in this age group. Four matched controls were established for each patient and the data obtained were subjected to statistical analysis. A statistically significant relationship was observed for three variables: diethylstilbestrol given during pregnancy (p=.00001), bleeding in that pregnancy (p=less than .05) and prior pregnancy loss (p=less than .01). It is obvious that the most significant of the variables is the administration of diethylstilbestrol during pregnancy. Since publication of this study, five additional cases of this malignancy associated with the maternal use of diethylstilbestrol have been reported by Greenwald et al. Dr. Herbst, in a recent communication to FDA, has reported an additional 15 cases associated with use of this drug, bringing the total number of known cases to 27. It must be emphasized that this type of epidemiologic study defines only an association and not necessarily a cause-and-effect relationship. Further studies are underway to clarify the significance of these findings.

In the meantime, the FDA is initiating the following precautionary actions:

  1. All manufacturers of DES or closely related congeners (dienestrol, hexestrol, benzestrol, promethestrol) are being notified that appropriate changes will be required in the labeling for such drugs. This change will consist in the listing of pregnancy as a contraindication to the use of diethylstilbestrol and the other above-mentioned compounds.
  2. All other estrogens will be required to have the following WARNING in their labeling: “A statistically significant association has been reported between maternal ingestion during pregnancy of diethylstilbestrol and the occurrence of vaginal carcinoma developing years later in the offspring. Whether such an association is applicable to all estrogens is not known at this time. In any event, estrogens are not indicated for use during pregnancy.
  3. Epidemiological studies are being initiated to determine the true incidence of this disease in young women, the number at risk, the characteristics of patient populations with this malignancy, and the probability of a cause-and-effect relationship.

Both FDA and the medical profession face a responsibility to help determine whether this reported association constitutes a cause-and-effect relationship. We ask that all physicians consider appropriate steps to assist FDA casefinding and to protect any patients who might be at risk.

It may be possible to trace the offspring of those mothers who received DES during pregnancy. All physicians should be especially’ alert for young women whose mothers may have received hormonal therapy during pregnancy, particularly those young women who may be experiencing irregular vaginal bleeding. The association should be a routine consideration for physicians whose practice includes young women.

This is a previously unsuspected health problem. Further information is essential to the FDA and to the medical profession. We ask your help in reporting any cases you encounter for entry in a case registry.

FDA will take every possible step to insure that you are kept abreast of new information as soon as it can be gathered and analyzed.

For your convenience, an adverse reaction reporting form is printed below. FDA will forward a supply of forms to each practicing physician as soon as they are printed. Facsimile forms are acceptable. ”

Remarks

Many articles about DiEthylStilbestrol (DES) mention that the Food and Drug Administration (FDA) banned DES for pregnant women in 1971.
The FDA did NOT ban DES, but issued a warning and urged doctors to stop prescribing it for their pregnant patients. Most doctors did, but not all, and the information regarding the contraindication took many years to reach France and other European countries where the drug continued to be prescribed to pregnant women. Since 1971,  many studies have shown a variety of health effects associated with DES exposure, adenocarcinoma but also breast cancer and infertility to name just a few.  In 2011, 40 years after the DES cancer link was made, the FDA acknowledged the DES tragedy but refused to apologize to the many victims of this drug scandal. To this day, not one drug company has ever apologized or accepted responsibility for the DES tragedy.

More DES DiEthylStilbestrol Resources

DES Books Library

image of diethylstilbestrol books
Awesome Flickr Gallery is a simple, fast and light plugin to create a gallery of your Flickr photos on your WordPress website.

Few years ago we started looking for DES images and videos, as mentioned on this gallery page.

With the years, the images have been arranged accordingly onto several Flickr albums.

Awesome Flickr Gallery:
fast, efficient and super easy plugin to create customisable photo galleries

Recently we found a WordPress plugin – demo version here – allowing to create multiple galleries with different parameters.

You’ll now be able to watch archived DES adverts, DES books,  manufactured DES drugs and DES research guides directly on this website.

Here is an example – on this post – with books about the DES tragedy.

[AFG_gallery id=’3′]

DES Adverts from Farming and Pharma Industries

image of DES adverts
DES Stilbosol patenting turned the cattle feed industry upside down in the mid 1950s with its phenomenal use by farmers.

Few years ago we started looking for DES images and videos, as mentioned on this gallery page.

With the years, the images have been arranged accordingly onto several Flickr albums.

Awesome Flickr Gallery:
fast, efficient and super easy plugin to create customisable photo galleries

Recently we found a WordPress plugin – demo version here – allowing to create multiple galleries with different parameters.

You’ll now be able to watch archived DES adverts, DES books,  manufactured DES drugs and DES research guides directly on this website.

Here is an example – on this post – from farming and pharma industries advertising DES.

[AFG_gallery id=’2′]

DES and Endocrine Disruptor Chemicals Research Guides

image of des-research-guides
Awesome Flickr Gallery is a simple, fast and light plugin to create a gallery of your Flickr photos on your WordPress website.

Few years ago we started looking for DES images and videos, as mentioned on this gallery page.

With the years, the images have been arranged accordingly onto several Flickr albums.

Awesome Flickr Gallery:
fast, efficient and super easy plugin to create customisable photo galleries

Recently we found a WordPress plugin – demo version here – allowing to create multiple galleries with different parameters.

You’ll now be able to watch archived DES adverts, DES books,  manufactured DES drugs and DES research guides directly on this website.

Here is an example – on this post – with DES and EDCs Research publications.

[AFG_gallery id=’4′]

DiEthylStilbestrol DES Website New Design

With 2016 approaching, we thought it was time to be back publishing posts as well as time for few changes…

image of a DES-tragedy sky
The “Evening rays” awesome graphic is by Douglas M. Paine, some rights reserved.

You’ve been exposed to DES,
so what?

Fist, the header image. There are hundred of studies which prove that DES has an endless list of side-effects. Some posts such as My DES Daughter Journey – Doctors (03.2011), Wanted: DES Aware Doctors (04.2011) and A focus group study of DES daughters: implications for health care providers (2000 study) mentioned the DES-victims distrust of the medical profession. So, we wanted a header reminding the severity of the DES tragedy as well the uncertainty of the future for the DES-affected  generations…

image of DES-responsible-design
WordPress says that theme Twenty Sixteen. will make your homepage look sharp on any device, and impeccable polish in every detail.

Fluid Design
and Responsive Images

Thank you theme Weaver for the years we spent together, from now on, we opted for the WordPress default theme for 2016: Twenty Sixteen.
Here are some of the theme new key features:

Introducing Twenty Sixteen

  • With or without sidebar, your call.
  • Overhang (the column) with a full-size image,wider than or equal to 840px.
  • Use the excerpt section to add a catchy, short post intro showing under your main header / post title.
  • Customize block quotes – put them left, right, where you like them!
  • Display links to your social media profiles with perfectly sized icons in the footer with a custom menu.
  • Add a call to action under your posts and pages, with 1 or 2 widgets displaying below your content.
  • For more information, visit the WordPress theme page and  demo version.

I can’t wait to get your opinion

Please tell me what you think, honestly, the good and bad…
Cheers