From the FDA Drug Label
Stopping TRINTELLIX suddenly may cause you to have serious side effects. Although TRINTELLIX can be abruptly discontinued, in placebo-controlled trials patients experienced transient adverse reactions such as headache and muscle tension following abrupt discontinuation of TRINTELLIX 15 mg/day or 20 mg/day It is recommended that the dose be decreased to 10 mg/day for one week before full discontinuation of TRINTELLIX 15 mg/day or 20 mg/day [see Warnings and Precautions (5.5) and Adverse Reactions (6)].
Side effects can appear later on with Trintellix, especially if the medication is stopped suddenly. It is recommended to gradually decrease the dose before discontinuing the medication to minimize the risk of serious side effects 1 1.
- Serious side effects may include discontinuation syndrome, which can cause symptoms such as nausea, sweating, changes in mood, irritability, and agitation.
- Gradual dose reduction is recommended to minimize the risk of these side effects.
- Patients should be closely monitored for any changes in their condition when stopping or reducing the dose of Trintellix 1 1.
From the Research
Yes, side effects from Trintellix (vortioxetine) can appear later during treatment, even after taking the medication for some time. While many side effects typically emerge within the first few weeks of starting the medication, some may develop after prolonged use. Common delayed side effects include changes in weight, sexual dysfunction, or mood alterations. If you've been taking Trintellix and notice new symptoms, don't stop the medication abruptly, but consult your healthcare provider promptly. They may adjust your dosage (typically ranging from 5-20 mg daily) or recommend strategies to manage these effects. The delayed onset of certain side effects relates to how Trintellix affects serotonin receptors and transporters in the brain, which can create cumulative effects over time. Regular follow-up appointments are important throughout your treatment to monitor for any emerging side effects and ensure the medication continues to be effective for your condition.
Key Considerations
- The most recent study 2 highlights the importance of monitoring bleeding tendencies in patients undergoing vortioxetine treatment, as it can cause abnormal bleeding tendencies, including tarry stools, ecchymosis, and massive uterine bleeding.
- Another study 3 found that vortioxetine was more effective than placebo in terms of response, remission, and depressive symptoms, but the clinical relevance of these effects is uncertain.
- A review of the pharmacology and clinical profile of vortioxetine 4 suggests that the medication displays high affinity for serotonin transporter (SERT) and serotonin 5-HT3, 5HT1A, 5HT7 receptors, and acts as a SERT blocker, a 5-HT3, 5-HT7 receptor antagonist, and a 5-HT1A receptor agonist.
Recommendations
- Patients taking Trintellix should be closely monitored for any emerging side effects, including bleeding tendencies, and report any new symptoms to their healthcare provider promptly.
- Healthcare providers should adjust the dosage or recommend strategies to manage side effects as needed, and ensure regular follow-up appointments to monitor the patient's condition.
- The medication's unique psychopharmacological properties may contribute to an improved clinical outcome in MDD patient populations, but further studies are needed to fully understand its effects.