Orilissa May Cause Suicidal Ideation

Orilissa (generic elagolix) is a drug from AbbVie Inc. and Neurocrine Biosciences, approved by the FDA in the summer of 2018, and prescribed for women with moderate to severe endometriosis pain. Endometriosis is a chronic disease in which uterine lining tissue grows outside the uterus. The drug shuts down the hormonal cycle, stopping the monthly menstrual period. It is currently being heavily advertised, with a list price of approximately $850 per month.

It caught our attention because some of the serious side effects are suicidal thoughts, actions, or behavior, and worsening of mood.

The prescribing information advises that patients with new or worsening depression, anxiety or other mood changes should be referred to a mental health professional. We urge caution, because a psychiatrist may misdiagnose such symptoms as a mental disorder rather than a drug side effect, and prescribe harmful psychotropic drugs instead of properly handling the side effects.

Suicidal ideation and behavior, including one completed suicide, occurred in subjects treated with Orilissa in the endometriosis clinical trials. Users had a higher incidence of depression and mood changes compared to placebo. Some of the most common adverse reactions in clinical trials included anxiety, depression and mood changes.

The drug is a gonadotropin-releasing hormone antagonist, which means it blocks the receptors of certain hormones in the brain’s pituitary gland, leading to the suppression of luteinizing hormone, follicle-stimulating hormone, estradiol, and progesterone. Patients are advised to limit the duration of use because of bone loss; bone mineral density loss is greater with increasing duration of use and may not be completely reversible.

The drug is metabolized in the liver by cytochrome P450 enzymes, so a person genetically deficient in these enzymes, or who is taking other drugs that inhibit CYP450 enzymes, is at risk of a toxic accumulation of the drug leading to more severe side effects.

There does not appear to be any scientific data about exactly why suicidality and behavior changes are potential adverse reactions, but we might surmise that messing with hormones in the brain is not exactly a well-known precision science.

The major issue we see is that mood changes as a side effect from Orilissa are likely to be misdiagnosed. Since psychiatrists do not perform clinical tests and are wont to prescribe an antidepressant rather than get to the root of the problem, we want to be sure every candidate for this drug understands the issue and practices full informed consent to any psychiatric treatment.

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