Antidepressants Side Effects, Effectiveness Questioned In New ISMP Report

A drug safety group is taking issue with a recent study on the overall effectiveness of antidepressants, indicating that it painted too rosy of a picture for a class of drugs that often do not work, and may carry serious and potentially life-threatening side effects. 

On May 16, the Institute for Safe Medication Practices (ISMP) issued its latest QuarterWatch Report (PDF), highlighting concerns about the safety and effectiveness of antidepressants.

The report took aim at a recent study published in the medical journal in The Lancet, which found that most antidepressants are more effective than a placebo.

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While the study indicated that not all depressants were equal, and determined that some appeared to be far less effective than others, the ISMP report suggests the study got a lot wrong, and resulted in too positive of an outlook.

As an example, the ISMP took a look at Trintellix (vortioxetine), a medication which fell about at the midpoint of effectiveness in The Lancet study.

Trintellix was put on the market in 2014, originally under the name Brintellix. However, Takeda had to change the drug’s name due to its similarity to Brilinta; a blood thinner.

The antidepressant drug is used to treat adult patients with major depressive disorders (MDD). It is part of a class of antidepressants called serotonin reuptake inhibitors (SSRIs), which are designed to re-balance chemical levels in the brain to decrease depression. The medication is manufactured by Takeda Pharmaceuticals

The ISMP noted that the drug has been linked to hundreds of adverse event reports of aggression and hostility, as well as suicidal thoughts, sexual desire disorders, and eating disorders; particularly excessive hunger and abnormally large food intake. Takeda told the ISMP that many of those reports may be linked to the patients’ depression and not the drug itself.

However, the ISMP also looked at data from clinical trials before the drug was approved, indicating that the results of those trials also show that the drug has limited effectiveness on top of potential safety issues.

“While the FDA judged it an effective treatment, vortioxetine failed to demonstrate a benefit in 4/10 clinical trials and the trials did not document more benefit than a placebo in U.S. patient subgroups taking the recommended 10 mg daily starting dose in any trial,” the ISMP noted. “Treatment failure occurred in 19%-20% taking vortioxetine, who declined to complete the trial primarily because of adverse effects or lack of efficacy.”

The ISMP report also indicates that those results were the best the clinical trial could do, even though it was limited to patients with the most severe forms of depression, where the odds of the drug showing a strong benefit were highest.

Trintellix was cited as one example of problems throughout the antidepressant drug class, which ISMP indicates The Lancet study failed to encapsulate.

“This review of vortioxetine illustrates that the new meta-analysis in The Lancet fails to communicate the marginal efficacy and substantial side effect profile of typical antidepressant drugs,” the ISMP report states. “The placebo effects were large (32% improved substantially), and the difference from the drug effect might be too small to detect without a sensitive scoring instrument such as used in the trials. Only more severe depression was studied, likely because previous studies in mild and more moderate depression have failed.”

16 Comments

  • AndrewJuly 1, 2023 at 7:59 pm

    Was misdiagnosed a few years back. Was put on trentellix by my doctor and had my teeth become brittle and broken. Thoughts of suicide and cane close. Also weird mood swings and aggression. Uncontrollable muscle spasms in my back. I stopped taking them only to be ridiculed by my doctor and lost my job of 11 years. Turns out I never needed them, and I believe it's malpractice on their part. There m[Show More]Was misdiagnosed a few years back. Was put on trentellix by my doctor and had my teeth become brittle and broken. Thoughts of suicide and cane close. Also weird mood swings and aggression. Uncontrollable muscle spasms in my back. I stopped taking them only to be ridiculed by my doctor and lost my job of 11 years. Turns out I never needed them, and I believe it's malpractice on their part. There meds have left me a shadow of who I once was. Nobody seems to care about the damage it and other meds have caused. My mind and body have changed and many people I know say that I have changed. Not to mention the weight loss.

  • SarahOctober 14, 2022 at 1:18 pm

    These comments OMG. I took this drug for THREE MONTHS in 2020 and it gave me severe Gastroperesis, for which there is no cure. It's like having the flu every day. I've seen several doctors, had procedures done, and I always need to be near a restroom. I'm 41 and just had to file for disability. My medical bills are piling up and I've been told by pretty much every law firm that they won't help me [Show More]These comments OMG. I took this drug for THREE MONTHS in 2020 and it gave me severe Gastroperesis, for which there is no cure. It's like having the flu every day. I've seen several doctors, had procedures done, and I always need to be near a restroom. I'm 41 and just had to file for disability. My medical bills are piling up and I've been told by pretty much every law firm that they won't help me because I waited too long to get help. IF YOU HAVE BEEN INJURED please reach out to lawyer as soon as possible. I can't believe others are having these horrible reactions, someone needs to be help responsible.

  • ChristopherAugust 29, 2022 at 4:34 pm

    I was on trintellix for a few years. It made me so sick i was throwing up 1-2x a day. I had to get my gall bladder out cause it inflame it. I had to fight to get off this medication. Please do not take this medication. Alot of my side effects included major headaches, not eating, jitterness, uneasyness in public.

  • PJune 6, 2022 at 1:28 am

    Gained 30 pounds in 3 months on this med. BMI went from 21 to 25, blood pressure went up, hemoglobin A1C now indicates I am pre-diabetic. I was athletic and thin before, I could run weekly 5Ks with a double stroller; now I’m panting getting up the stairs. In 3 months, due to fatigue and appetite increase and lack of motivation brought about by Trintellix. Early on I became paranoid, I thought my h[Show More]Gained 30 pounds in 3 months on this med. BMI went from 21 to 25, blood pressure went up, hemoglobin A1C now indicates I am pre-diabetic. I was athletic and thin before, I could run weekly 5Ks with a double stroller; now I’m panting getting up the stairs. In 3 months, due to fatigue and appetite increase and lack of motivation brought about by Trintellix. Early on I became paranoid, I thought my husband was going to kill me. I’ve been off it for a month and a half and while I’m active again and my caloric intake is way down, no added sugars, limiting carbs, deficit of close to 1000 calories a day., The weight won’t come off. Anyone dieting and exercising like this would have lost 10 pounds by now; I’ve lost 3. So it’s affected my metabolism as well.

  • LindaMay 15, 2022 at 6:50 am

    My son committed suicide 5/11/22. He was on Trintellix for about 4 weeks. My family is horrified , devastated - we are shattered I am writing this through tears and tears and tears Please post about your loved one if they were on Trintellix

  • JenniferOctober 17, 2021 at 1:26 pm

    I was but on trintellix in May 2021. The second day Inwas manic for about 4 hours. By the end of the week I was treated for a UTI, but I did not actually have one. I ended up in the ER three times on this med after only taking it for two weeks. I have been off of work since July for severe anxiety and bladder issues from the medication. I thought I was actually dying and contemplated suicide [Show More]I was but on trintellix in May 2021. The second day Inwas manic for about 4 hours. By the end of the week I was treated for a UTI, but I did not actually have one. I ended up in the ER three times on this med after only taking it for two weeks. I have been off of work since July for severe anxiety and bladder issues from the medication. I thought I was actually dying and contemplated suicide as my mind was on fire. I have never, ever had those thoughts previousIy. This med has ruined my quality of life. Now I have to take 1mg of Ativan daily in order to function. I have tried so many SSRIs in the last 18 years and they have always made things worse, but this is by far the very lowest point of my life.

  • EllieApril 20, 2021 at 10:02 am

    My mom committed suicide at 52yo. My mom was put on Trintellix for stubborn depression by a GP. We didn't know that she was actually Bipolar & that the drug brought about a horrible case of mania with psychosis & aggression which continued & strengthened long after she stopped taking it. When she finally came down from her mania, she was a shell of a person. She stopped eating, she stopped talki[Show More]My mom committed suicide at 52yo. My mom was put on Trintellix for stubborn depression by a GP. We didn't know that she was actually Bipolar & that the drug brought about a horrible case of mania with psychosis & aggression which continued & strengthened long after she stopped taking it. When she finally came down from her mania, she was a shell of a person. She stopped eating, she stopped talking. The depression that ensued was extreme, I don't think she could have felt worse. About 8 months after starting Trintellix for only 3-4 weeks, she committed suicide.

  • JeanneApril 14, 2021 at 2:23 am

    I did not have any side effects from Trintellix at first. I vomited and was in horrible pain for a year and eight months. I didn't realize it was from Trintellix. And not one doctor found what was causing the violent vomiting. I quit my job, thinking it was stress. I finally looked more into the medication and titrated down and stopped Trintellix. My severe symptoms went away.

  • ShannonJanuary 20, 2021 at 1:04 am

    I had so many horrible side effects brain zaps, worse everything and was NEVER warned about permanent uncontrollable muscle movements which I have now and can no longer take any SSRI bc it triggers it to become extreme

  • ChristineNovember 8, 2020 at 9:24 pm

    I had perfect vision prior to taking this. Within 6 weeks I have had considerable vision loss and can not function without corrective lenses.

  • JessicaMay 14, 2020 at 1:47 am

    Trintellix has caused my teeth to become brittle.

  • DavidMarch 5, 2020 at 7:54 pm

    my son committed suicide at 3 weeks on the medication.

  • RobFebruary 14, 2020 at 1:28 am

    I took Trintellix for a month and had to stop because I was feeling suicidal and homicidal, and my mood was rather intense and making my Anxiety worse.

  • PattiFebruary 13, 2020 at 5:12 am

    My husband committed suicide after 2,5 weeks on Trintilex.

  • LisaOctober 30, 2019 at 10:40 am

    Since taking trintellix I have lost almost 50% of my vision and some slight memory loss.

  • RebeccaJuly 1, 2019 at 12:27 pm

    Since taking trintellix I have had memory loss and problems with speech.

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