FDA Monitoring Fibromyalgia Drug Savella (Milnacipran HC) for Suicidal Ideation

By Lucy Campbell

Washington, DC: Due to reports on its Adverse Event Reporting System (AERS) of potential suicidal ideation, the Food and Drug Administration (FDA) has placed the antidepressant Milnacipran HCI (Savella) on AERS watchlist.

Savella is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), similar to some drugs used for the treatment of depression and other psychiatric disorders. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.

Savella is mostly prescribed for fibromyalgia, a condition that may cause ongoing pain, muscle stiffness and tenderness, tiredness, and difficulty falling asleep. According to the Mayo Clinic, fibromyalgia affects women more than men and there is no known cause. There is also no cure for fibromyalgia at present. Savella fibromyalgia treatment is possible option for patients who may suffer from the condition.

The FDA is continuing to evaluate this issue and any potential association with Milnacipran HCI (Savella) to determine the need for any regulatory action.

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Last updated on Apr-25-12

READER COMMENTS

Posted by
Kori Fehl
on May 29, 2019

I was on Savella for a short time after being diagnosed with fibromyalgia in 2016.
I started having side effects that were concerning and I called my doctor at the time and I was told to let the medicine work the side effects will go away.
The side effects did not go away they only intensified. I ended up in the ER and almost died.
My blood pressure was so high I was losing my vision. I was slurring my words and at times I made no sense and my heart palpitations were so fast that had I not gone in I would of had a stroke and died.
It wasn't until after I stopped taking it did I find out about the consumer watch group begging to pull this drug. Its a shame that we as patients have to almost lose our lives in hope's to feel better and yet the drug is still on the market and still endangering lives all for the almighty dollar big pharma gets.

Posted by
Renee White
on September 9, 2018

I was on Savella for 9 mo i went to Dr multiple times due to abnormal and very high heartrate 12-05-2013 while driving to work at 330 am i blacked out coming off freeway and wrecked at hospital i was diagnosed with a permanent heart condition ive had to be cardioverted 9 times all Drs including cardiologist say its drom raking Savella in 2010 a group called concerned citizens begged the FDA to pull off market due to ireversable heart damage in every 1 out if 8 people that take this med plus severe suicidal ideation this drug needs to be pulled off market

Posted by
Rachel
on June 12, 2017

If this goes to suit, I would gladly be a participant. I took Savella for a short time about 6 years ago. The effects it had on me were horrible - I was very irrational, depressed, and making bad decisions. Luckily none of them came to fruition, however, sane people don't get in the car with the intention of going to the airport to fly somewhere because they get in a fight (that I started) with my husband. This is/was not typical behavior for me unitl I started the medication. Once I stopped taking it, I was pretty much back to myself. It is very scary how much medication can affect you.

Posted by
Paula Westman
on January 15, 2017

I was prescribed Savella in 2010 for body pain. It worked awesome for me until May,2011! I woke up shortly after midnight to my heart pounding hard and beating very fast! Within the next 3 months, I was hospitalized and had an ICD placed! I was told my heart looked like a "coke addicts" heart! I have NEVER done any drug! One of the side effects to Savella is a fast heart rate. I also have been told there are other countries "FDA" who didn't approve the drug, due to poor outcomes of the studies or not enough studies! Why would America Pharmaceuticals do this to "we the people"?

Posted by
diane van orman
on July 10, 2016

Savella almost killed me. I fought suicidal feelings that were overwhelming. I lost 38 pounds and was so weak I couldn't stand, walk, or talk. I couldn't drive until 3 1/2 months later. I experienced horrific migraines, unbearable body pain. It changed my eye color and sight. Loss of dexterity and tremendous memory loss, especially trying to articulate my speech. I feel as if I had experienced a stroke. I will never return to previous poor health and strength, now it's terrible. I have multiple pages of what I documented over the months of recovery. I hate Forrest Laboratories for selling this dangerous drug. I hallucinated and heard things! Absolutely terrifying. Forrest Labs. told my mother they don't even manufacture it. It is produced in the Arabic countries. I felt like this drug was a deliberate attempt to kill people. I am not exaggerating.

Posted by
Maria Anne Rubio
on June 18, 2016

I took Savella for 1 about a year. I stopped taking due to suicidal behaviorsand thoughts, aggressive behaviors & depression.

Please include me in the class suit.

FDA Monitoring Fibromyalgia Drug Savella (Milnacipran HC) for Suicidal Ideation

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