Say NO to meds that don't work AND can harm babies!

Say NO to meds that don't work AND can harm babies!

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MedShadow Foundation started this petition to FDA

Let’s please sign and share this NEW petition to encourage the FDA to stand by its decision to remove Makena from the market. Makena is a hormone, given to pregnant women who are told it will prevent premature births, but it has been proven that it does not prolong pregnancy. Instead, it exposes both mothers and their babies to unknown risks without any benefit. 

The manufacturer has had ten years to prove the drug works, and they haven't, because it doesn't. And some doctors want to prescribe it anyway because there isn't a drug to give pregnant women at risk of preterm birth.

Every drug has a side effect and that's why a drug that doesn't work must be removed from use. Preventing drugs like Makena, which don’t work and may harm patients, is the mission of both MedShadow Foundation and DES Action USA.

Makena was approved in 2011, under the FDA’s accelerated approval pathway -- a special designation for drugs that meet a significant unmet need (which Makena would, if it worked. About 10% of babies born in the US are premature, which puts them at increased risk of long term health issues and even death.) That allowed the drug to enter the market before the Phase III clinical trials demonstrating its effectiveness were complete. The manufacturer, AMAG, agreed to complete these trials after the approval. Nearly a decade later, those trials have confirmed that this drug does not prevent preterm birth. And thanks to many voices, including DES Action, MedShadow, and most importantly, you, our supporters, the FDA is taking notice.

We’ve seen this before with DES (diethylstilbestrol) another hormone that was given to women from the 1940s-1970s with the false promise of preventing premature births. This drug had no benefit and caused serious side effects that weren't discovered until several decades after the DES was prescribed. Harms included breast and cervical/vaginal cancers, infertility, and more that affected mothers, their babies, and now the grandchildren of those first pregnant mothers. MedShadow’s founder, Suzanne, is a DES daughter, her mother was given the drug in pregnancy. That's why she founded MedShadow and is the executive director of DES Action.

Last fall we circulated a petition asking the FDA to remove Makena from the market -- and now the FDA has recommended exactly that! But the pharmaceutical manufacturer, AMAG, has challenged the FDA, asking for another review. This is not warranted: AMAG has had a decade to prove that Makena helps pregnancies; we already know it doesn't work.

The FDA has taken a huge step in recommending Makena's removal but the fight isn’t over yet. It’s crucial that the FDA actually removes Makena from the market entirely, as opposed to changing its indication to reflect that it doesn’t prevent preterm birth. If the FDA chooses to do the latter, doctors will continue to prescribe the drug and patients will continue to be exposed to risks and potential harm of which they are not informed.

Even if you signed our last petition, please sign this new one and share it with friends, family, and on social media. They deserve the protection of the FDA. 

0 have signed. Let’s get to 1,500!
At 1,500 signatures, this petition is more likely to get picked up by local news!