MedShadow Guides Those That Have Taken Drug as Makena Is Removed from U.S. Market
Makena will now be removed from today’s marketplace, but it will take decades to know what damage has already been done. What should women who have taken Makena do now?
Following a 14-1 vote by the U.S. Food and Drug Administration’s (FDA) Obstetrics, Reproductive, and Urologic Drugs Advisory Committee recommending that Makena be removed from the market, its producer, Covis Pharma, has agreed to voluntarily withdraw the drug from the market. The vote, and requests from nonprofits like MedShadow to remove the drug, come after a 2020 FDA study that found the medication to be ineffective.
A Long Battle to Safety
DES Action USA has worked for many years to get the FDA to withdraw its approval of Makena. Joining many organizations in testifying to the FDA in person and in writing, the nonprofit supports this removal.
“The withdrawal of Makena by the manufacturer comes after years of concern about this drug, which has been marketed by other drug companies and with other names, like Gestiva,” says Kari Christianson, former Program Director of DES Action USA and Board Member of MedShadow Foundation. DES Action is a collaborative nonprofit organization of MedShadow Foundation.
Long-Lasting Side Effects
While the withdrawal of the drug from the market is a positive step, there are an unknown number of women who were prescribed the drug and may suffer from lasting side effects. Those exposed in utero are also uncalculated. What are they to do now in order to track and protect themselves from the potential, long-term impacts of the drug?
MedShadow Founder and President Suzanne Robotti advises women who have taken the medication to keep solid records.
“Women should obtain physical copies of their medical records, listing all drugs prescribed when trying to get pregnant, while pregnant, and while breastfeeding,” said Robotti.
Robotti knows how serious the implications of such medications can be, as she herself is a DES Daughter, because her mother was prescribed DES during the pregnancy. DES, or diethylstilbestrol, was given to pregnant women to prevent miscarriage. Sadly, this endocrine-disrupting did not prevent miscarriage and instead caused adverse health effects, particularly in the daughters of the women given the drug.
Over the past 50 years, research has linked DES exposure to cancers, infertility, and more. Research about DES is still in process, but has revealed how the effects of an endocrine-disrupting drug can continue for generations.
While DES is a nonsteroidal estrogen, and Makena is a progestin hormone, DES Action has long had concern that any hormone given to a pregnant woman during pregnancy may have an endocrine-disrupting effect on the pregnant woman and her unborn child.
The Importance of Medical Records
DES Daughter Joanna Katzen agreed with Robotti, saying that saving any documentation and proof of prescriptions will be a key that may help understand future impacts.
“Any woman that has taken Makena should keep her prescription information and pill bottles showing names and dates, and to keep hard copies of their medical records showing the same,” said Katzen. “They should give these to their children at some point (or even will the items to them), and they should be told to keep them indefinitely. All items should be kept in a safe place.”
If women have additionally lost a baby and taken Makena, records will be incredibly important to track lasting side effects, possible multi-generational impacts, and provide proof in any upcoming suits on the matter. Robotti said that it is important when taking any medication to track your records carefully.
“My advice to all mothers and all women who lost a fetus, if they were given even a single drug from the start of attempting to get pregnant through breastfeeding, get a copy of your own medical file and request it lists all drugs,” said Robotti. “Put a search alert on any drug listed in your record, so that you will hear about problems in the future. Then lock the file in a drawer for the long haul.”
MedShadow Foundation’s Mission
MedShadow Foundation is the independent, online nonprofit health media platform that protects people from the harm of medical side effects with informative, research-based health journalism. MedShadow does not accept any funding or support from pharmaceutical companies or medical device manufacturers and is free from their influence. The organization was founded in 2012 by Suzanne Robotti, a health/patient advocate who currently serves as the sole consumer representative on the FDA Drug Safety and Risk Management Advisory Committee. For more information on the nonprofit, visit www.medshadow.org.