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Savella Recall Urged by Public Citizen Due to Heart and Suicide Side Effects

The prominent consumer group Public Citizen has petitioned the FDA to initiate a recall for Savella, saying that the fibromyalgia drug’s heart and suicide risks outweigh its benefits.

The Savella recall petition was sent to the agency on January 20, calling for the drug’s immediate removal from the market. Public Citizen claims that the benefits of the drug are highly questionable, and note that side effects of Savella could increase the risk of hypertension, heart problems and has been linked to suicidal tendencies.

Savella (milnacipran) is produced by Cypress Bioscience, Inc. and Forest Laboratories, Inc. It is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) and is similar to many antidepressants currently on the market. The drug is contraindicated for people taking monoamine oxidase inhibitors (MAOIs) and those who have uncontrolled narrow-angle glaucoma.

It was approved by the FDA for treatment of fibromyalgia in adults on January 14, 2009. While the drug is used as an antidepressant in Europe, the European Medicines Agency (EMEA) refused to approve Savella for fibromyalgia treatment in July 2009, saying that the drug had marginal benefits that failed to outweigh the health risks from Savella side effects.

Fibromyalgia, or fibromyalgia syndrome, is a condition that manifests as widespread chronic pain and is estimated to affect between 2-4% of the population. However, much of the medical community disputes how to diagnose the syndrome, and many do not believe it is an actual disease because of a lack of objective diagnostic tests and physical abnormalities on examination. While some say it may be a neurological condition, possibly brought on by stress and resulting in oversensitive pain receptors, others say it may be a “non-disease.”

According to Public Citizen, two randomized clinical trials with Savella found that the drug increased blood pressure, heart rate and suicidal thoughts. Nearly 20 percent of the trial’s participants who were given Savella developed hypertension, compared to 7.2 percent who were given a placebo. Public Citizen said that FDA’s own reviewers determined that Savella could increase the risk of heart problems, such as strokes, heart attacks and sudden death, by as much as 50 percent.

The group claims that studies have shown Savella increases the risk of seizures, addiction, excessive bleeding, mood disorders, fractures, glaucoma, nausea and vomiting. They also indicate that the drug can put fetuses, newborns and nursing infants at risk when used by pregnant mothers, and can cause reproductive problems in men.

In addition, Public Citizen says that there is evidence that the drug does not work. Public Citizen claims the director of FDA’s Division of Anesthesia, Analgesia and Rheumatology Products has said that Savella did not relieve pain, the main symptom of fibromyalgia, in clinical trials.

“Fibromyalgia is a chronic disease, but neither of the drug’s trials showed any statistical effectiveness beyond three months,” Public Citizen said in a press release. “And even within the trials’ three-month duration, more than 90 percent of users in the trial received no benefit from the drug at all.”

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Image via: Art Konovalov / Shutterstock.com

323 comments

  1. Bobbi Reply

    I have very mixed feelings re Savella. It has brought my moderate pain down significantly, lifted some depression and cleared my foggy mind in the 3 months that I have been on the medication. My doctor put me on 50mg twice a day after completing the trial pack. I felt it was still too high and gave me a combination of side effects (mixed up speech, aggitation, constipation, flushes and headache.) My doctor then reduced to 25 mg twice a day and I still felt that was too high so I am taking a very low dose of 25 mg once a day. Now I have developed a urinary tract infection (I am not sexually active) and when I checked if this could be a side effect…sure enough it is! The reason being is that it can reduce KIDNEY function so they aren’t able to remove all of the waste in your system!! This really got my attention!! Permenate kidney damge is a possibility!! So I will take my antibiotics for the infection and slowly ween myself off of this drug. It just has too many possible side effects that are really scary…we all need our kidneys!! I hvae read a lot about “low dose Naltrexone”…it has zero side effects and is super affordable.Good luck everyone!

  2. Lisha Reply

    I was so sick from this med. I threw up for over a year. was sent to every doctor all the way to birmingham. in and out of the hospitals, 3 ICU ‘s the last was because of an suicide attempt. I had never before or after wanted to take my life!!! i still am having problems from this medications, i have had to have 6 teeth puled 4filled, and got to see an oral surgen to take another.fortunatley no permant organ damage even though one of the icu was because of my kidneys was shutting down. i have never been so sick in all my life. this is a very short summery of what Savella done to me and my family.

  3. Lisha Reply

    Had almost all sideeffects worse was the suicide,when I talk to someone or can write my story PLEASE HELP US !!! A lot of these blogs sounds just like me!

  4. Vickie Reply

    I have been taking Savella for 3 years!!! My quality has been so much improved on Savella!!! Two years prior to starting Savella I had been through the gambit of everything including Lyrica which was horrible!!! Lyrica needs to be removed from the market! I was taking Cymbalta right before I switch to Savella. I was having problems with sleep also. I would wake up multiple times during the night and it took a long time to fall back asleep. I was not having dreams and I was hyper vigilant during the night. I tried different types of sleep aids including Ambien CR but it would still not keep me asleep or allow me to go back to sleep. My sleeping pattern was verified by a sleep study that showed I was not reaching REM sleep at all and the test showed I woke up 17 times from 9pm to 5am using Ambien sleep aid. This test was done while I was on Cynbalta for my Fibromyalgia pain. Nine months later I switched to Savella 200mg, 100mg in the 100mg in the evening and within 2 weeks I was sleeping so much better and without using a sleep aid!!! The biggest improvement in my sleep was being able to reach REM the dream state, I had not had a dream in years. I woke up fewer times and was able to turn over and go back to sleep when I would wake up rather than be awake for long periods of time. I have never had any problems with Savella causing me hypertension and I am 52 years old with a bp of 118/74, I’m 5 ft 3 in 190lbs. Thank you Lyrica for the extra 30lbs! Please, Please, Please, DO NOT get rid of Savella!!! It is a Miracle drug!!!! Doctor’s need to make sure they are giving to the right patients. It may not be right for every fibrimyalgia or pain patient who asks for it, so Doctors need to do their job and not give it to someone they know may not be right for the drug just because the ask for it!!! Also, anyone can write negative comments over and over when trying to show a drug is bad and needs to be removed. All comments need to be verified by medical records to be considered authentic before any action should be considered!!!

  5. amy Reply

    I started savella a few months ago. Before the drug my life was my bed. I didn’t do anything felt horrible and was in constant pain. Now I am active and I no longer am in continuous pain. I have had some itching due to the medication, but benadryl helps. There are side effects to ALL medicines. I think it should be chosen based on an individuals results from it. I have not had any other side effects and it works great for me. its funny how a drug for incontinence that can cause uncontrollable diarrhea can stay on the market for so long, but a drug that helps some they wànt to take off. there are lots of medicines out there that only work for some people. I’m on my 3rd acid reflux medicine and it still ain’t wong and have all caused stomach pains and nausea. does that mean they should pull those medicines that have been on the market for years.? some people are narrow minded and only think of what’s best for them and nevermind the ones it helps. if its taken off the market my life will once again consist of laying in bed all the time. one last thought … I have no thyroid and ALL of the thyroid replacement medicines can cause increased heartrate headaches and itching. does that mean I should stop taking it and let myself die all because of the side effects. in my opinion the benefits far outway the side effects of sevella.

  6. g. Miller Reply

    I have been on Savella for 8 days now and I am going out of my f***ing mind I am sick to my stomach can’t eat hate everyone, I have nausea, headache, constipation and dizzy. As for my pain it seem to be much worse I am also taking more of my pain medications. I have fits of rage it just not me.

  7. Jessica Reply

    I have been taking Savella since around Fall of last year for Fibromyalgia. My heart rate has increased, resting stays at about 130. I have tried talking to my doctors for months. Telling them I don\\\’t feel well, no explanation for new dx. of increased heart rate. NO ONE IS LISTENING. I followed up with a Cardiologist. No explanation as to why I know have fast heart rate. No one is doing anything to help me. My fast heart rate along with other symptoms I can only contribute to taking Savella. I hope this drug does not cause my long term/harmful side effects. I hope those able do consider doing the right thing. This medication can cause serious complications/problems.

  8. MommaC Reply

    Have been on this medications for years, now come to find out I have kidney disease and this is probably the culprit. If there is a lawsuit, contact me. Doctors should warn their patients about the side effects of these medications.

  9. mike Reply

    Its a nightmare on Savella for the short time i have been. I found no pain relief and severe psychological side effects. I have had to manually wean myself quicklu as i could not afford the copay, by cutting pi has there is not an un titration pak to ramp down as there was to ramp up…but then i have lost conf in my phys anyway. I was arrested and went to jail for first time – started weaning next day.

  10. Lori Reply

    I am an RN of 15 + years. Fibro has made it impossible for me to work. I BEGGED my rhuemy for this medication. Anything to get my life back right?! Now I have uncontrollable sweating even at rest. BP & HR are through the roof. Palpitations & chest pain? Oh yeah! I am either angry or crying all the time. I think about suicide & how throughout the day EVERY day! I have had my \\\”cycle\\\” for 31 days with bleeding heavier on what would be my normal days UGH I have lost 14 lbs in a month & a half. Constipation, stomach cramps…Yes to all. I can\\\’t believe I asked for this! Spoke to my PCP on the phone for a good hr tonight. She believes I will have to be hospitalized to get off of this med, will decide when I see her in the morning. I just wanted my life back …now I really don\\\’t care. 2 months on this medication, I will say I am med sensitive to majority of meds. If it has worked for you terrific, I would not want to see anyone with relief from Fibro lose it but it surely isn\\\’t for everyone!

  11. Michele Reply

    I just wanted to say that I experienced some unusual & bothersome side effects after being on Savella for a month. Hot flashes irregular heart beat, dizziness, terrible sadness, shortness of breath, nausea, dry mouth & insomnia.
    ‘Lori’ also mentioned dry mouth (4/10/10), but looked at it as a positive thing because it made her drink more water – that’s great! However, I suffered from dry mouth terribly from being on too much pain medicine in the past. It caused extensive damage to my teeth so be really careful and maybe try to use dry mouth rinse to help maintain the health of yours.
    I also want to say that my pain from Neuropathy, Fibromyalgia & injuries from several car accidents has gotten better since going through (voluntary) treatment for opiate & benzodiazepine over-use. I was a complete wreck and could barely function when on high doses of these meds. PLEASE be careful & aware of the pain doctors who want to keep increasing your pain meds to conquer the pain, it can be way more detrimental to you.
    Good luck to all who suffer these conditions & diseases, it can be so frustrating and devastating. It’s a constant fight but keep it up until you find the right doctor and the right treatment. I’m not there yet but gaining.

  12. Kathy Reply

    I have stopped taking Savella due to dramatic increase in GERD, palpitations, increased heart rate, increased blood pressure, headaches, and muscle weakness. All of these concerns were significant and constant. It decreased my pain by about 30% but was not worth the serious side effects.

    I believe if I had continued, it quite possibly could have killed me. Now I am just hoping it did not so permanent damage. THIS DRUG IS NOT SAFE.

  13. GEF Reply

    I have been taking Savella for 3 years for severe fibromyalgic pain. It’s the ONLY medicine that has worked. I won’t claim to know exactly what fibromyalgia is, but I can assure anyone who reads this, it’s certainly not a “non-disease” and wouldn’t wish it on my worst enemy. I would not be exaggerating to say that it has given me my life back. I couldn’t get up and down our stairs at home without severe pain, sometimes on my hands and knees. Thank you Savella!!

  14. Monzon Reply

    I have experienced the worst side affects while taking Savella for nearly 3 weeks. I had suffered terrible headaches, dizziness, hypertension, and severe chest pains that place me in the ER 3 times within one week. I also had painful muscle aches and stiffness that I could not walk nor communicate and a lot of weakness that cause a serious amount of injury, even after I have wean off the medication, I was still experiencing the unpleasant headaches, pain, and aches. Savella was definitely a poison, horrible, life-threaten drug to me!!!

  15. jen Reply

    My bf started taking savella 3 days ago.before this he was on effexor with no problems. On the 2nd day of.taking savella I noticed him being impatient and easily agitated. By the 3rd day he was vomiting and having suicidal thoughts as well as harming others before he hurt himself. Currently he is in a mental services ward until the medicine is out of his system. Seeing his.moods flip like a light switch and hearing him tell me.the thoughts he was having has been.one of the most difficult things I.have ever been.through. his dr gave him this med.to help with depression, not fibro

  16. Michelle Reply

    I took Savella when it first came on the market for two years. I experienced bad hypertension, both legs got a rash, profuse sweating, redness of upper extremities, and retinopathy brought on by the hypertension. Unfortunately neither my fibro doctor or my eye specialist knew enough about the drug, so I was kept on it. Finally I took matters into my own hands and did research on the medication. One thing I found was it was not tried on patients who also had migraines who were on migraine drugs. When savella posted a warning to glaucoma patients I knew there would be something to this. Also no one ever thought savella could be linked to retinopathy, however, when you research retinopathy you discover extreme hypertension will cause it.

    So after two years of side effects much of the damage is now permanent. Doctors didn’t take me off the meds so finally I weaned myself off them. After about four months the leaking into my retina stopped. However, after one year the damage to the retina is permanant, it is now scar tissue. The rash on my lower legs left. My blood pressure is normal. All of this damage could have been prevented if someone would have listened to me. I even contacted Forest Labratory. No one listened to the patient.

    I did talk to my pharmacist and warned her of this possible side effect in case someone else comes in with this condition on this med. My doctor later tried to put me on a sister drug to Savella, I declined. It is not worth my eyesight!

  17. Lori L. Reply

    I couldn’t make it through the titration pack! This drug caused me to feel intense rage, hopelessness, desperation, paranoia and suicidal. I do not believe the problem is related to my tolerance, or lack there of, to SSRIs. Maybe it only has this affect on people who have been diagnosed with clinical depression. I took Effexor XR without these side effects for 12 years. I transitioned to Cymbalta XR, 30mg, and continued for 2 years without these side effects. My experiences with Savella started nearly at once, on 25mg. I took Savella for less than 2 weeks and thought I was receiving messages from God, believed everyone at work was plotting against me and felt that suicide might be the answer to several things. I stopped taking it on Saturday and went back to Cymbalta today (Monday). All of this madness has stopped after only one 30 my dose of Cymbalta. If Savella is not removed from the market then at the very least, studies should be performed to determine it’s specific effects on depressed users.

  18. Sheila Reply

    Ever since I started taking Savella ( 50mg 2 times day) for my fibromyalgia the main side effects I have experienced is unexplained right upper belly pain. The muscles in my stomach seem to flex and tighten up whenever I try and stretch as well. I can not eat a regular meal. I am always nauseated. I can only eat very small amounts of food if I manage to at some point even in the middle of the night I get up to throw up. I have not seen any decrease in my pain level. I have developed worsening migraines. Worsening depression. Overall I feel worse since I have started taking savella. I am now in the process of weaning off this awful drug. It should never have been released.

  19. John Reply

    Clearly reduced overall pain levels. Works well.

  20. Madge Reply

    Was on it for a few years and wound up with tachycardia and high blood pressure for which I am still taking meds. While there is a family history of heart disease it’s not either of theses. I am not overweight, I exercise and eat well. While coming off it I had to be without medication for the fibroymyalgia for several weeks which was excruciating. While they say it in the small print it obviously very small since a cardiaogist knew I was taking it but did not connect it with these symptoms I was suffering.

  21. Jill Reply

    Amazing how similar my experience is to most of the stories on this site. Especially Lori’s comments from Halloween day last year. I’m a RN, BSN who worked for 10+ yrs at a children’s hospital in our city before having to quit due to worsening RA and fibro. I’ve been through a long list of meds since being diagnosed in 2001, but starting Savella has been one of the most difficult experiences medwise. I’ve been on it for a week now and am experiencing the worst leg muscle pain upon standing that I’m needing to use my walker again. Also having difficulty with incontinence, burning, frequency, urgency but apparently no UTI!?! Experiencing sore throat, pounding and fullness in both ears with runny nose and shortness of breath. Heart is pounding and skipping beats. Also worsening low back pain and blurry vision. After reading the other stories of people having permanent damage, I suppose it’s time to wean off yet another med. Just hoping I’m able to wean it off before permanent side effects occur. NOT WORTH IT!!

  22. Angela Reply

    I believe savella builds up in your system. If you are lucky enough to make it thru the worst few months of nausea and vomiting,I did because it helped my pain, the nausea never goes away,the hot flushes and breaking out in cold sweat then the blood pressure goes up. I had everything on the list. Finally after taking it about 16 months the upper right abdominal pain and severe vertigo did me in. I stayed off of it 8 months,the pain from the fibro was so bad I couldn’t walk, I tried it again. The same thing happened, i ended up with the severe vertigo and right abdominal pain in bed not able to raise my head for a week. I did not know this medicine would cause permanent damage. I do know the side effects never go away and actually worsen the longer you take it!

  23. Ruth Reply

    I’m only on my third pill and am already running a 100 degree temp and just had the worst hot flash! I haven’t had one in 10 years, so I know it’s the medicine causing it.

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