Question

I just read about the FDA refusing to approve Esmya because of safety issues, and I’m concerned. I know ella and Esmya are chemically the same, so should I be worried about similar issues when taking ella?

Answer

Both ella and Esmya contain the chemical compound ulipristal acetate, a selective progesterone receptor modulator. Selective progesterone receptor modulators work by blocking the body’s ability to react to progesterone, causing hormonal changes. However, the similarities between ella and Esmya begin and end with the chemical compound they share. The two drugs are very different when it comes to how they are used.

ella is a type of emergency contraceptive, which means that it is sought out in the immediate aftermath of a slip-up in order to prevent unintended pregnancy. Those using ella take a single 30mg pill within five days of having unprotected sex. Users can take ella on multiple occasions in the case of multiple slip-ups, but is not is designed for continuous use.

Esmya, on the other hand, is a medication intended to shrink uterine fibroids. Fibroids are growths in the muscle tissue of the uterus that often cause heavy bleeding and other uncomfortable symptoms. Even without causing symptoms, fibroids usually result in changes in the size or shape of the uterus. Esmya is used to manage and shrink these tumors. Esmya was approved at 5mg dosage by the European Medicines Agency (EMA), the European version of the FDA, and has been used there for several years.

Esmya is intended for continuous use. That means that, while one ella pill is a higher dose than one Esmya pill, Esmya’s cumulative dose is much higher. This is true whether Esmya is taken for a few months before surgery, as it was initially approved for in Europe, or taken long-term. Because of this, patients taking Esmya have a very different risk of complications than patients taking ella. There have not been any reports of safety issues with ella.

However, there have been reports of serious safety issues with Esmya, and the FDA recently told the sponsor of the drug that it will not approve Esmya for use in the U.S. In Europe, several women experienced serious liver damage while using Esmya. Four of these women actually had to undergo a liver transplant. In light of these complications, the EMA launched an investigation into Esmya and its potential health risks and instituted new restrictions on its use. The EMA is currently advising patients to be tested for liver damage before taking Esmya, avoid using it if they have pre-existing liver damage, and to limit use to just three months, in preparation for surgical treatment of their fibroids. The EMA advises all women taking Esmya to have regular liver function tests, and warns against repeated use of Esmya, except in the situation where an individual woman cannot undergo surgery.

In contrast, no ella patients have reported any instances of liver damage, and data supports ella’s safety and efficacy as an emergency contraceptive. The NWHN continues to endorse ella as an option for emergency contraception. However, we believe that the FDA made the right decision to say no to Esmya.

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