Every drug has a side effect. For that reason, a drug that doesn’t work must be removed from use. Drugs like Makena, which don’t work and may harm patients, is the reason that both MedShadow and DES Action USA exist. And when it comes to Makena specifically, we’re thrilled to announce we have made massive progress! Thanks to more than a thousand of your signatures on our petition, the FDA’s Center for Drug Evaluation and Research (CDER) recommended on October 5th that the drug be removed 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 pharmaceutical manufacturer, AMAG, has challenged the FDA and asked for another review. This is not warranted; AMAG has had ten years to prove that Makena helps pregnancies and it does not.
Please sign our NEW petition asking the FDA to stand by its decision and remove Makena from the market.
DES (diethylstilbestrol) was another hormone that was given to women from the 1940s-1970s with the false promise of preventing premature births. That drug had no benefit and it caused serious side effects that weren’t discovered until several decades after DES was prescribed. The side effects 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 is a DES daughter, her mother was given the drug in pregnancy. Read more about Suzanne’s experience and why she founded MedShadow and is the executive director of DES Action.
Makena was approved in 2011, under the FDA’s accelerated approval pathway — a pathway designated 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.) The pathway allowed the drug to enter the market before the Phase III clinical trials demonstrating that it was effective 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. Thanks to many voices, including DES Action, MedShadow, and most importantly, you, our supporters, the FDA is taking notice.
The FDA has taken a huge step in recommending Makena’s removal but the fight isn’t over yet. The manufacturer, AMAG requested a hearing in which it hopes to convince the FDA to keep Makena on the market. 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 can 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 the new one. Let’s insist the FDA stand by its decision to remove Makena. The manufacturer has had ten years to prove it works, and it doesn’t.
Please sign and share the petition with friends, family, and on social media. They deserve the protection of the FDA. And don’t forget, MedShadow and DES Action are nonprofits relying on your contributions, please donate what you can to continue to support our cause!