Protect pregnant women and their children from hormones!
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A progesterone drug approved to prevent preterm labor has been proven to be ineffective.
Don't let history repeat itself! A generation ago estrogen given to pregnant women to prevent miscarriages caused cancers and reproductive birth defects in the children exposed in utero.
More than 5,000,000 pregnant women were prescribed DES (diethylstilbestrol), an estrogen drug, from 1940s -70s. Studies showed DES was not effective, but doctors still prescribed it. That hormone exposure interrupted the development of the fetus’ endocrine system and resulted in rare cancers, breast cancers and reproductive organ defects in the children -- which weren’t apparent until 20-30 years after the exposure to DES. Some of the DES damages are showing up today in the grandchildren of those mothers given DES.
Today pregnant women are prescribed Makena, a progesterone to prevent preterm birth. The pharmaceutical company's own studies showed it is NOT effective at preventing preterm birth, but some doctors want to continue to prescribe it to pregnant women, because they think it "doesn’t do any harm." This is a different hormone, but no one is testing the children for signals of endocrine disruption. No harm? There is no way to know.
The FDA has proof that Makena doesn’t work to stop preterm birth. This drug has no reason to be allowed on the market any more. The FDA approved Makena acknowledging that the research was not complete and therefore required post-approval studies for just this reason. We demand that the FDA remove it from the market.
The FDA Bone, Reproductive and Urologic Drugs Advisory Committee has unanimously agreed that the drug is worthless and a majority voted it be taken off the market. It's not enough if the FDA takes away its indication for prenatal use. In the case of DES the FDA sent a "Drug Bulletin" urging doctors not to use it but did not remove it from the market. As we know, many doctors didn't believe the FDA and kept prescribing it for years longer -- causing unknown amounts of cancers, fertility problems and heartbreak. (For more information about DES and the damages it caused, go to www.DESAction.org
If Makena merely has its indication changed then some doctors who are convinced that they have seen results will order it compounded. Makena must be pulled off the market and placed on the list of drug products that have been withdrawn or removed from the market for reasons of safety or effectiveness and therefore may not be compounded under the exemptions provided by sections 503A(a) or 503B(a) of the FDCA.
We who were exposed to DES either by being prescribed it while pregnant or exposed to it in utero and the grandchildren are the most harmed. We and our families and friends understand the risks and pain of hormones in pregnancy. We will speak out now that pregnant women are again being assaulted with hormones that have not, and cannot, be proven safe in pregnancy.
Please join us in demanding that the FDA protect women and children: take Makena off the market and do not allow any hormonal product interrupt the precious development of a fetus.
The FDA must pull Makena off the market by Adam C. Urato https://www.statnews.com/2019/11/14/fda-pull-makena-lessons-from-des/
Public Citizen petition to the FDA: https://www.citizen.org/wp-content/uploads/2493.pdf
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