On October 28, based on the research from the manufacturer, the FDA was able to approved LILETTA, a 52mg levonorgestrel-releasing intrauterine device (IUD) for up to 6 years of use, making it the longest approval for any levonorgestrel-releasing IUD in the US. Here is what you need to know.
LILETTA: the background
There are currently four levonorgestrel-releasing IUDs on the market: LILETTA (52mg), Mirena (52mg), Skyla (13.5mg) and Kyleena (19.5mg). Both LILETTA and Mirena have 52mg of levonorgestrel, making them very similar in practice. However, LILETTA is unique in that it was brought to market in 2015 and manufactured by Medicines360, a non-profit pharmaceutical company working to improve access to the IUD for everyone who wants one, regardless of socioeconomic status or geographic location. Clinics with 340B designation are able to purchase LILETTA for a discounted rate in order to make it accessible to more people who need it. You can find more information about LILETTA [here](https://www.lilettahcp.com/, sign up for updates here, and find updated Bedsider materials for patients here.
Why the change to 6 years?
Current research shows that an IUD with 52mg of levonorgestrel, like LILETTA, is effective and safe to use beyond the original FDA approval. The science showing that IUDs are effective beyond the original FDA approval continues to improve as time passes and it is possible to study them for longer periods of time. Additional evidence suggests that IUDs with 52mg of levonorgestrel, like LILETTA and Mirena, are effective for at least 7 years, but the FDA approval of Mirena has not changed. The manufacturers of LILETTA designed their clinical trial testing effectiveness to extend through 7 years and that research is ongoing through 2020.
Counseling patients who are having LILETTA placed
When you are placing IUDs and implants, a conversation about the discrepancy between the FDA approval and the evidence can be potentially long-winded or even unnecessary. While these methods are shown to be effective beyond the FDA approval and patients may desire to use them up to the maximum, evidence shows that the average duration of use tends to be much shorter.
So, if you already know from previous conversations with a patient what is most important to them about their birth control method and how long they plan on using it, you may not need to share all of the details of the FDA approval process. This is a great opportunity to engage your patient in shared decision-making about their birth control.
Here are some general points to cover when counseling patients about LILETTA and FDA approval:
- All LILETTA IUDs are now FDA approved for 6 years. This new approval doesn’t just apply to new ones that are placed going forward. If a patient already has the LILETTA IUD, it’s good for 6 years.
- Good evidence shows that an IUD with 52mg levonorgestrel is safe and effective for at least 7 years.
- Printed package materials may not match current FDA approval and/or current research.
- Patients can always come in to have their IUD strings checked, discuss satisfaction, ask about the latest FDA approval, and talk about how long they plan to use their IUD.
Counseling patients who already have a LILETTA
You may have anticipated expanded FDA approval and therefore had this conversation with your patients about LILETTA when placing it. Patients presenting for removal of LILETTA IUDs after 3 or 4 years may not feel comfortable continuing to use their method beyond the previously FDA approved maximum. If they don’t feel comfortable continuing with their IUD after you’ve explained the new FDA approval, you should replace it.
Stay tuned—we anticipate that LILETTA will get FDA approval for 7 years!