On October 15, the FDA approved LILETTA, a 52mg levonorgestrel-releasing intrauterine device (IUD) for up to 5 years of use. Here is what you need to know.
Why change to 5 years?
Current research shows that an IUD with 52mg of levonorgestrel, like LILETTA, is effective and safe to use for up to 5 years. Additional evidence suggests that they are effective up to 7 years. 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. 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 tricky and potentially long-winded! However, if you already know from conversations with your patients what is most important to them about their birth control method, you may not have to delve into a 1hr CME on the FDA. While these methods are shown to be effective beyond the FDA usage and patients may desire to use them up to the maximum, evidence shows that the average duration of use tends to be much less. This is a great opportunity to engage your patient in shared decision-making about their birth control.
General Counseling Points
- Liletta is currently FDA approved for 5 years
- Good evidence shows that an IUD with 52mg levonorgestrel is safe and effective for up to 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, and talk about how long they plan to use an IUD
Counseling patients who already have a LILETTA
You may have had this conversation with your patients about LILETTA and anticipated expanded FDA approval when you placed their LILETTA. Patients presenting for removal of LILETTA IUDs after 3 or 4 years may not feel comfortable continuing to use their method beyond the FDA approved maximum. It is reasonable to replace an IUD at that time or at any time that your patient requests removal.
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 all women, 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, sign up for updates here, and find Bedsider materials for patients here.