Savella Recall Urged by Public Citizen Due to Heart and Suicide Side Effects
Published: January 21st, 2010 • Comments: 21
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.”
Comment by Gina on 22 January 2010:
I have been taking Savella for almost a year now and have had none of the side effects in the petition and have had great results. I have taken the other 2 meds which the side effects were overwhelming to the point of having to cease taking them. For the first time in 10 years I have relief from my firbomyalgia.
Comment by Colleen on 24 January 2010:
I have taken this drug for almost a year now. I have had no trouble and for me it is a godsend. When I miss a dose, I am in unbearable agony. Have tried Lyrica and it didn’t work. As far as those who don’t believe in it, I hope they experience this kind of pain someday.
Comment by Hylary on 25 January 2010:
I have been taking Savella for about 2 months now and have seen a major decrease in my fibromyalgia symptoms. I had previously taken Lyrica and Neurontin, both drugs used to treat symptoms like mine and they did nothing for me. I tried Savella and had results very quickly. I have had none of the side effects that have been stated here and my doctor has been monitoring me (at my request). And I had a heart condition before, and it’s perfectly stable. My blood pressure has not risen over 130/75 since I have been on this medication. I have received benefits from this drug. This is the only medicine that has given me any relief and I’ve been through a lot of pain and misery over the last few years.
Comment by Erica on 25 January 2010:
I have been on savella for month or so now, it works great, not to many side effects, although I noticed my blood pressure has increased slightly
Comment by pauline on 26 January 2010:
I began savella 7 months ago , i had great relief of pain, slept better,etc. With the news of heart and bp problems, it all made sense. I had a high pulse, shortness of breath, and high blood pressure. I ended up having a complete cardiology work-up with a stress test. So,i quit and all my vitals are back to normal.
Comment by Pamela on 30 January 2010:
The effect was good with less pain and weight loss as compared to Lyrica and Neurontin, but all of a sudden I too my usual drug for bad headache and off to the hospital I go after I had sent a scathing resignation. Then the depression following kept me in the hospital a week. This drug is not rsted enough. My blood pressure went WAY UP and the mental health of a patient is just as important as the physical health. I may have damage to organs as a result of the reaction not to mention loss of a job. Please take this drug off until further testing and correction is done to help those of us that got the SEVERE side effects.
Comment by dominique on 1 February 2010:
I have been on savella for nearly 2 months now and have felt zero benefit from it. My mood has changed DRASTICALLY, I’m agitated anxious and irritable not to mention completely withdrawn. I have no appetite, I have to force myself to eat all the while being afraid it is going to come back up. The most horrifying that I read about savella is that if you do not ween yourself off of it you can have symptoms similar to that of electric shock. Sorry but this med needs to be looked further into! Good luck to all of you in your fibro battle!
Comment by Dot on 2 February 2010:
I have had positive results from Savella and have been taking it for the last eight months. It has helped reduce my overall body pain significantly. This is the only medication that has helped my pain and I’m very concerned that it will be yanked from the market.
I think everyone should have the chance to at least try Savella, while under the supervision of a physician. I have sent a letter to Public Citizen telling them this. I think a better solution would be a stronger warning label and a long-term medical study to find out the long-term effects.
Just published a blog post with my email to Public Citizen, and details on how you can contact them with your Savella experiences.
http://www.fibroworld.com
Comment by Steve on 4 February 2010:
I started taking Savella last week and the day I stepped up the dosage in the starter pack I felt like HELL and nearly fainted after a bath. I checked my blood pressure and it was elevated as was my pulse. My pulse remained in the 110 to 120 area – as a resting pulse – for much of the day while I had the sensation of shortness of breath and dizziness. I was googling side effects when I ran into an article on how…there was a call to take Savella off the market due to – hello – problems with it elevating BP.
Listed side effects also mentioned it was problematic for men with prostate issues, which the prescribing doctor not only knew I had, but was partly prescribing the drug for.
I know that the sense of feeling awful should settle down, but that alone was hard to handle, let alone that it was demonstrable from my BP monitor that the drug was jacking up my pulse and BP.
Comment by Barbara on 4 February 2010:
I was diagnosed with fibromyalgia approximately 5 years ago and have been treated with several medications. I was put on Savella 1 1/2 months ago and had a great respose. However, after titrating to the 50 mg twice a day and I started experiencing “chest pain”. Was hospitalized and had to have a cardiac workup which was negative. Now the delemia is stay on a decreased dose of Savella and put up with the chest discomfort or stop the Savella and risk not feeling as well as I do.
Comment by Belinda on 7 February 2010:
I have been on Savella for several months now,it helped at first. But now I am worse off than I was. Headache, aching back,all over pain weakness. I wish a drug could be found that really helped fibromyalgia. Instead we get these drugs shoved in our faces and are told the studies show this helps more with the pain ect. I has helped my fog a very little. We just need something to help the pain go away.
Comment by Bill on 9 February 2010:
I started taking Savella on Jan 5, 2010. As the dose inccreased (within the first week), my blood pressure started to increase. It went dramtically higher than it had ever been. By the following week I became depressed and anxious, got shaky and confused to the point of having to leave work. I didn’t know it was the Savella so I kept taking it another week before finally figuring it out – duh. During this time I was a complete basket case, had to go on FMLA leave, and incurred costs from repeated doctors visits, as well as the stigma of having had an apparent nervous breakdown.
I am now getting back together and looking forward to going to work — although somewhat embarassed by the whole thing. I am convinced that Savella put me at serious physical and mental risk. I would be very cautious if you decide to try this medication.
Comment by Jan on 11 February 2010:
OMG…I took the Savella for my fibromyalgia for three days. By the 2nd day I was loosing my mind. I had low blood pressure 80/40ish, shakes, dizziness, fainting, ringing in my ears, constipation, sad, tears, chest pains, palpations (horrible); lets just say I had every symptom on the box but vomiting…I called my doctor on the 3rd day and was taken off the Savella, thank GOD!!! I am having to follow up with my heart doc due to this medication. I have mitro value prolapse and this medicine kicked my MVP into rare form. I’m looking at having surgery in about a month.
Comment by Chris on 17 February 2010:
I am having a hard time trying to figure out what does and doesn’t work. I am so many different medication for everything else. I have a lot of different vitamins, psych meds, meds for IBS and CFS. My vitamin D levels were negative. I go to get iron transfusions every couple of months because of the Mediterranean Anemia I have that is nationality based, I can’t really notice a difference between this and Lyrics. They upped my Lyrica so much I looked like a drunk. I had Gastric Bypass Surgery in 2002 so I don’t absorb anything but half of these meds. I wasn’t diagnosed with Fibro until last year. The body weight i ended up with was cause by 1 year of taking Depakote and Effexor. I had extreme 2 year Vertigo and Menieres at the itime, I can track my aching at least to 1988. My doctor blamed the Flexeril for my high blood pressure and she is the one that put me on it. I have the Alpha Female doctor who is never wrong. So it is time me, my brother and sister all find someone else at the same time who actually does their job. The toughest issue is having DID better knows as Dissociate Identity Disorder. Once called Multiple Personality disorder. No, I am not a nut job by any means. The problem is that Fibro does not effect them all of the same way, the blood pressure and temperature depends on the person. Allergies totally different. We don’t have the same eyesight. My younger ones still climb on jungle gyms and hang upside down at the top. They don’t even have Fibro so they younger ones to what they want and the rest of us don’t get pain from it. It is a fascinating disorder but medically hard to treat. I have noticed that many are still complaining about migraines. We had just also had a surgery on our C1-C2 discs in our spine. So two plastic discs, a metal plate and screws. Doctor said the Fibro will be worse and it can take almost 2 years to heal. Me and my guys are not people who like to rest. It just isn’t in us. I am sure that makes matters worse. Does anyone have a problem with neuropathy out here? Some of us can pick up boiling hot things and not feel a thing. I have burns ion my fingers and even wrists. Guess I ws hoping someone experienced the same thing. I may even enjoy heearing myself talk ,,lol
Chris
Comment by rose on 17 February 2010:
I am on my 5th day of Savella. My Neurologist suggested I try it for my chronic myofacial leg pain. So far I only had nausea the 2nd day but i have taken Maalox every day with it. I thought I would try to stick it out for a month to see if it helps with pain. However yesterday I had a very unusal crying spell. ( I never cry) TIme will tell I guess.
Comment by Gigi on 18 February 2010:
I am on Short Term Disability because of this nasty drug.
I was on the 2wk titration pack and HOLY COW the suicidal tendencies kicked in on day 3. Add to the mix that I am Bi polar too.
Not only was I feeling and acting nutzoid my Fibromyalgia pain GOT WORSE!
Savella darn near cost me my sanity, maybe my job and I am in MORE PAIN BECAUSE OF SAVELLA. I’ve reported my experience to the FDA and say “Take it off the market now!”
Comment by Mel on 1 March 2010:
I am currently on Savella and it has improved my pain and fatigue drastically. It has reduced both by at least half. I have had almost no side effects, just slight nausea for about 30 minutes. Compared to Cymbalta which made me have uncontrollable vomiting, dizziness, balance problems, unpredictable moods, and more it’s a God send. I don’t know what I would do without it.
Comment by Evelyn on 3 March 2010:
I have been on Savella for a year now…Iin combination with Lyrica for my firbromyalgia. I have noticed a decrese in pain for awhile and now am starting to feel the main more ..needles in my back so to speak..muscle aches and more joints issue which my doctors have told me to accept I have prominate fibro and I am not going to get better just worse…So, I am stopping the Savella and seeing if it truly helps…But as far as side effects I have NOT had not one…Cymbalta I almost lost my mind…Lyrica I swell a little but that is not enough to stop me from taking that drug..It has helped me and the combinations of the 2 drugs Lyrica and Savella helped me…So I think with any drug in this area; there is going to be issues and each person is different with their bodies and that anything anyone takes not everyone is going to have issues…look at Cymbalta..it worked awesome for some people and then people like me I had sucidial thoughts…What is the difference here…each patient should be accessed closely on these medication anyway….
Comment by Patsy on 10 March 2010:
I have suffered life threatening events since starting Savella in May, 2009. I sufferd from excessive sweating, nausea, headaches, insomnia irregular heartbeat, fatigue, constipation, and dizziness. After several doctor visits, I had surgery September 30, 2009 and a pacemaker and defibrillator were implanted.
I was rushed to the hospital again on February 11, 2010 with severe chest pain, sweating and unable to swallow. When examined in the ER, my blood pressue was 205/138. I was diagnosed with serotonin syndrome. I have no history of hypertension, and my cardiologist insisted I stop the Savella. I am continuing to improve every day. Most of my symptoms have disappeared. I had also been taking Lyrica for about six years. Upon my doctor’s advice, I have stopped it too.
I have never had a reaction to medication in the past. My advice is to pay very close attention to the warnings about side effects.
Comment by larry on 11 March 2010:
I have a client who took the drug in an “experimental” setting and had dramatic mood swings and very bizzare behavior. He ended up in jail-no prior problems and had no memory of the events that led to his arrest.
In jail his BP rose and he suffered a stroke!
Comment by Yelitza on 17 March 2010:
I have had very positive results from Savella and have been taking it for almost a year now. It has helped reduce my overall body pain significantly and increase my energy. Although Cymbalta was very helpful, Savella is great. It would be terrible to recall this product since there are people who truly find in Savella help for our fibro symptoms. Is just as simple as try it and check if it work for you. If not you just quit it.
This reminds me of Vioxx recall, which caused so many people tears cause it was the drug that helped them with their pain, while with Celebrex the FDA just put a warning in the label. This is what should be done with Savella.