Vortioxetine is a new medication for depression recently approved by the FDA. It is loosely related to the serotonin reuptake inhibitors (SSRIs–think fluoxetine (Prozac), sertraline (Zoloft), citalopram (Celexa), and paroxetine (Paxil)) , but also affects norepinephrine, like desvenlafaxine (Pristiq) and duloxetine (Cymbalta), and has different effects on different serotonin receptors, giving it the potential to have different effects and side effects than the SSRIs and the SNRIs. The makers of vortioxetine admit that at this time, we don’t know how/if the different mechanism will make a difference in the effects of the medication.
General information: Vortioxetine comes as a film coated, unscored, immediate release tablet in all recommended doses: 5mg, 10mg, 15mg, and 20mg. The starting dose is 10mg once daily for everyone but the elderly and those taking certain medications. Effectiveness and side effects both increase with the dose of vortioxetine. Like other antidepressants, maximum effectiveness is not usually seen for several weeks (4-8 weeks) on medication at the correct dose.
Pros
Vortioxetine has been shown to be more effective than both venlafaxine (Effexor) and duloxetine (Cymbalta) for symptoms of major depression.
With regard to sexual dysfunction, vortioxetine has not been directly compared with most other antidepressants. The package insert reports a rate of sexual dysfunction of around 34% or less for males and females taking various doses. However, another study with more participants reported higher rates of dysfunction (up to 51%) with fairly low doses with fairly similar rates of dysfunction compared to duloxetine.
Vortioxtine over the long term causes neither weight gain nor weight loss.
Vortioxetine is not sedating and does not impair driving performance, compared to mirtazapine.
Like all antidepressants currently on the market, vortioxetine decreases the risk of recurrence of major depression over the course of a year.
Vortioxetine is being investigated as an antianxiety medication. Most other antidepressants can be used to treat anxiety.
Cons
Vortioxetine is a new drug. For a few years it will be patented and therefore not available as a generic. The cost will likely be high until a generic becomes available. Takeda has a patient assistance program but it remains to be seen if Brintellix will be covered.
Vortioextine is a new drug in a new class. This means we don’t know what kinds of side effects may show up once it has been out on the market for a while. We do not know of its potential effects during pregnancy or nursing, nor of its effects on the developing brains of children. Also, we do not know much about the long term effectiveness or side effects of the medication since the longest study of vortioxetine was for just one year.
Gastrointestinal side effects such as nausea, constipation, and vomiting can occur. It usually starts around day 1 or 2 of treatment and usually stops around the 2 week mark, similar to the SSRIs. If you have mild to moderate nausea, it usually is best to wait out the 2 weeks to see if you will feel better.
Discontinuation syndrome can occur if doses of 15-20 mg daily are stopped suddenly, similar to some SSRIs. Symptoms include headache, muscle tension, mood swings, outbursts of anger, dizzineness, and runny nose. Typically, if a person wants to stop vortioextine and they are taking a higher dose, it should be tapered to 10mg for a week, if possible.
Low sodium levels (especially in the elderly and those taking certain diuretics) have been seen in patients taking vortioxetine.
Even though clinical trials did not necessarily demonstrate certain serious side effects that could be caused by vortioextine, they are presumed to be risks because of vortioextine’s mechanism of action. These risks include a temporary increase in the risk of suicide (especially in teens and children), activation of bipolar mania, abnormal bleeding (especially if you take aspirin or other medications to thin the blood/prevent blood clots, are diabetic, or are older than 65), and serotonin syndrome.
To sum up:
Overall, vortioxetine (Brintellix) is new and different. It has not yet proven itself definitely superior for the treatment of depression, but it provides another option for patients struggling with what can be a debilitating disorder. The ideal candidate for treatment with vortioxetine would be an adult who either hasn’t gotten better on at least two antidepressants (taken separately or together), or who has had side effects with at least two antidepressants. Those new to medication, or who are pregnant would do better to consider other medications whose long term effectiveness and side effects are better known, and whose cost is less.
References:
Brintellix [package insert]. Takeda Pharmaceuticals America, Inc, Deerfield, IL; September , 2013. http://www.takeda.us/products/default.aspx/actospro/prescribinginfo.aspx Accessed October, 9, 2013.
“NOW APPROVED FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER.”BRINTELLIX. Takeda Pharmaceuticals, USA, 2013. Web. 14 Oct. 2013. .
