You may have seen news articles and press releases flying around the Internet since yesterday regarding a new drug released to manage Endometriosis pain. I wanted to share this with you because, although I’ve no intention of taking the drug myself, I know that it may help women who suffer. And it may help better educate you on your decision.
I’ve been following it for a while and you can read my thoughts about AbbVie’s SpeakEndo commercials and website, as well as their expedited application for FDA approval, and the track records of other drugs that have done the same. And according to Business Insider, Orilissa may cost approximately $850 per month, or roughly $10,000 per year for prescriptions (I’m assuming those figures are calculated without health insurance). Orilissa is estimated to hit markets for prescriptions in August of this year.
So, here you go:
On July 23, 2018, the Food & Drug Administration approved AbbVie’s new drug to treat Endometriosis pain. You may have seen it referred to as Elagolix, but it has been officially named Orilissa. It is an oral GnRH antagonist.
Please do your own thorough research before talking to your physician.
In the Resources section below is a link to the FDA’s drug fact sheet, which includes a .pdf of the pamphlet that should come with the drug. Read it. Review the clinical trials. And decide for yourself. You can read the .pdf which I have downloaded, or by accessing the FDA’s site and downloading it for yourself.
It appears it has limited allowable dosing (6 months to 2 years), may cause liver issues, may cause bone loss, may cause depression and suicidal thoughts, and may interact with hormonal birth control. Some adverse reactions during clinical trials included appendicitis, abdominal pain, back pain, hot flashes, night sweats, nausea, decreased bone mass density, headache, insomnia, mood swings, depression, lack of a period, anxiety, joint pain, decreased libido, diarrhea, weight gain, dizziness, constipation, and irritability.
One participant in the clinical trials committed suicide two days after she stopped treating with the pill. She was 44 years old, had treated for one month, and had no medical history or life stressors that would have been indicative of suicidal thoughts.
Where did I get all this info? The FDA drug pamphlet.
Don’t trust me, read it for yourself.
Weigh the pros and cons.
And talk to your doctor.
A February 2019 study showed that women in Phase 3 Trials of Elagolix had improved period pain and non-period pelvic pain than those who were given the placebo pill. It stated that most adverse events were mild to moderate, but there was a risk of bone loss among patients.
And a June 2019 study showed that women in a 6-month clinical trial that were given Orilissa were at work 2-4 hours longer per week than women who were given the placebo, improving their attendance.
An October 2019 study written by Dr. Brian Ford of the Naval Hospital at Camp Pendleton shared a few warnings about Orilissa: Orilissa may decrease the effectiveness of some oral contraceptives, so non-hormonal contraception to avoid pregnancy while on Orilissa. The most common side effects that forced participants to drop out of the clinical trials were hot flashes and night sweats. There’s a risk of decreased bone density. Mood changes, depression, and/or suicidal thoughts may occur. The way the body metabolizes certain medications may be altered because of the way Orilissa affects liver enzymes. Other side effects reported in the trials were an absence of a period, headaches, and insomnia. Compared to the placebo group, after 3 months of trials, 46% of women taking the 150mg of Orilissa and 72% of those taking the higher 250mg dose had improved pain menstrual pain while on the drug. Dr. Ford stated that 28-day supply of Orilissa costs approximately $870. Due to the expensive nature of the drug, as well as the adverse side effects similar to other drugs (such as Lupron Depot), Dr. Ford recommends that ” Elagolix should be reserved for women who do not benefit from nonsteroidal anti-inflammatory drugs or hormonal therapy. ” Just a few thoughts to chew over and discuss with your physician…
We are our best advocate. Do what you feel is best for you. But, please, do it informed and do it safely.
Knowing how poorly my body handled Lupron Depot (another AbbVie product that is incredibly similar), and how I became so severely depressed and suicidal on it, I will never again subject my body to something similar. It did nothing in the long-term to stem my Endometriosis. And was an incredibly difficult journey while on Lupron, as well as a long while before my body cleared itself of any side effects. That is why I choose not to take Orilissa. The decision is an individual one. Never again. But, again, I will never tell you not to try something; it may very well help you cope with your symptoms. Understand, though, that it is a band-aid. It will mask your symptoms; not clear your body of Endometriosis. I learned that one the hard way…
If you do your research and make a well-informed decision to start (or not start) Orilissa, I wish you all the best of luck and health. There are no judgments here. Only well-wishes.
And, if you wish to see a quick snapshot of the participants and findings of the two clinical trials, please visit this FDA page.
**Updated October 22, 2019**
AbbVie – (July 24, 2018; Press Release) AbbVie Receives US FDA Approval of Orilissa (elagolix) for the Management of Moderate to Severe Pain Associated with Endometriosis
American Family Physician (Oct. 15, 2019; Article) Elagolix (Orilissa) for Endometriosis Pain
Business Insider (July 24, 2018; Article) A New Treatment for a Condition that Can Feel Like Tiny People Skating on Razor Blades in Your Stomach and Affects an Estimated 200 Million Women Just Got Approved
Drugs & Therapy Perspective (Feb. 2019; Abstract) Elagolix in Endometriosis-Related Pain: a Profile of its Use and Approved in the USA
Fertility & Sterility (June 2019; Abstract) Impact of elagolix on work loss due to endometriosis-associated pain: estimates based on the results of two phase III clinical trials
US Food & Drug Administration – Drug Database: Orilissa
~ Again, I am a layman. I do not hold any college degrees, nor mastery of knowledge. Please take what I say with a grain of salt. If curious, do your own research 😉 Validate my writings. Or challenge them. And ALWAYS feel free to consult with your physician. Always. Yours ~ Lisa