US consumer advocacy groups are up in arms. New and devastating Reclast side effects led these groups to demand that new warnings be placed on the drug's label.
As I wrote in my Reclast review, the most commonly reported Reclast side effects are fever, muscle, joint and bone pain, flu-like symptoms, and fever. And I also explain how it can cause osteonecrosis of the jaw and its horrific consequences.
But these pale in comparison to the new concern.
Read the full story below:
03/10/2011 | TRUMAN LEWIS | CONSUMERAFFAIRS.com
Does Canada care more about its citizens' health than the U.S.? It sometimes looks that way.
The consumer group Public Citizen wants the U.S. Food and Drug Administration to do what Canada apparently did five months ago – tell Novartis to warn physicians and consumers about a dangerous link between a widely-used osteoporosis drug and serious renal toxicity, which can result in death.
In a letter to the FDA, Public Citizen's Health Research Group said the Canadian government reacted after learning of 265 cases of serious kidney impairment in patients using Aclasta (zoledronic acid). The drug is called Reclast in the U.S. and is identical to the Canadian version.
Five months later, the FDA has done nothing, said Public Citizen's Sidney Wolfe, M.D., in a letter to FDA Commissioner Margaret Hamburg, M.D.
“The Food and Drug Administration (FDA) has failed to take … action requiring Novartis to alert physicians and patients in the United States about the growing evidence linking Reclast to this serious, life-threatening adverse event,” Wolfe said. “We therefore urge the FDA to immediately require that Novartis issue a similar “Dear Doctor Letter” to all physicians in the U.S.”
Reclast is given once a year for treatment of osteoporosis in men and postmeopausal women and once every two years for prevention of osteoporosis in postmenopausal women.
Wolfe noted that more than one million infusions of Aclasta had been administered worldwide as of October 2010. The 265 cases of renal impairment reported in Canada corresponds to a rate of about 20 cases per 100,000 patient-years of exposure. The FDA estimates that no more than 10 percent of adverse drug reactions are reported.
“Clearly, the current warnings and precautions in the FDA-approved label for Reclast about the risk of renal impairment are not sufficient for making physicians adequately aware of this serious, life-threatening renal toxicity associated with Reclast, the very reason that the Canadian government convinced the company to initiate the additional warnings,” Wolfe said..
Source: Consumer Affairs
I started getting sick after receiving a infusion of Reclast (age 80) in 2012. It started with flu like symptoms with shortness of breath that never left me me for almost a year. I started feeling better but did not go back on Reclast as I was afraid. However, a year and a half later, I got a compression fracture in my back so I thought I should go back on something. My doctor recommended Prolia. After two shot my shortness of breath returned. I stopped the Prolia but I guess the damage had been done. I was finally diagnosed with Interstitial Pulmonary Fibrosis in 2018. This is a 0.1% rare reaction. Do not take these drugs you do not know what will come in the future.
I’ve probably experienced every symptom other people have mentioned. I received my reclassify in 2007 for Paget’s Disease. Now when my body get’s really bad if dogs lick my skin they have seizures and on occasion when visiting shut ins they have called me to tell me they got so sick “they thought they were going to die”. No physical contact involved but heavy sweating precluded the visit.
I was diagnosed with breast cancer in 2016. Already had osteoporosis and now on cancer meds that make it worse. T score is minus 3.4.
I get Reclast every year. I fact, I get it tomorrow. I walk 5 miles every day. I make sure that I am taking 1200mg of calcium daily and 800mg vitamin D. I hydrate well before the IV and continue to do so for days after. I also have the nurse infuse it over 1 hour. I have never had any problems with Reclast.
I had two or three reclast infusions in the past 3 years. I have been having severe fatigue the past 2 years and for over a year experiencing weird, deep bone pain in my shin bones. Been to numerous doctors and they just dismiss me like I am nuts. I am so discouraged. Would just like an answer since I worry my mother died from osteosarcoma. I just want to know if this is a side effect and if it will get better because it seems to be getting worse.
I had many years of mysterious symptoms. I was diagnosed with MS in 2001. In 2008, I went on a gluten free diet. My MS symptoms lessened within days, not to return 10 years later. I was diagnosed with severe osteoporosis in 2005. I had horrible side effects to Fosamax. In 2008, the doctor wanted my to take Reclast. I refused thinking that it would kill me. She told me to leave the office! How much of a kick back do you think she was going to get? The gluten free diet also helped with my bone density. I also have Celiac disease, which is the ROOT of all my problems. That’s why the gluten free diet helped with everything. NO DRUGS…NOT SIDE EFFECTS. Food is medicine!
You are not nuts. I had one infusion of Reclast in August, 2013, and within three weeks I was leaking protein in the urine and started getting extreme bone and/or muscle pain. These are not like regular muscle cramps. Here I am 6 years later, on an immune suppressant (cellcept) for the rest of my life, which has its own problems. I never had a kidney problem in my life. I would strongly suggest you test for protein in the urine tested (there are no symptoms). I had only one infusion and the damage was verified by kidney biopsy (IgA nephropothy). From my point of view it is an immune system disorder. My body responded to the drug by dumping IgA immunoglobulins throughput my body and the kidneys cannot filter them, which causes scarring in the kidneys. Basically kidney failure if not caught. I have other drug allergies. My primary doctor also did not check for creatinine clearance before the infusion. The damage from this drug is real – if you are one of the unlucky ones/ and the damage is permanent.
Have been suffering from constant pain in my hands, right elbow and knees since taking Aclasta (Reclast) in August 2017. Does anyone have any idea how long this pain is likely to continue? I would never have that treatment again. I have oestoepenia but believe the odd break would be less debilitating than constant pain. I live in NZ. They tell me that no one else has had the side effects I have had but from this blog I see it’s very common. Shame on the medical community. I also have some fatigue and my eyes get quite sore and scatchy at times. Recently I have started to feel itchy at times but that doesn’t last long. Anyone know how long it takes for the body to get rid of this poison?
My Dr said only 10% have side effects from Reclast but from what I’ve been through and read from others, I believe it is much higher. My infusion was in Oct. 2018. I feel worse now than I ever did. My knee hurts constantly and I get easily confused. I would not recommend nor will I have this infusion again. Drs. are not upfront about the side effects.
I had my first reclast infusion 10/30/18, within 24 hours I had flu like symptoms for 8 days! I am 48 years old and go to the gym for strength training 3 times a week since Feb 2018. Since the infusion, I have gained 12lbs! Despite my continued dedication to diet and exercise. My hip bones constantly hurt and now my bottom jaw hurts so badly I can’t even chew on that side. Of course the my doctor says my weight gain is “probably” not related and that my hips “probably” hurt from all my time at the gym.. so in other words, totally dismissing the fact that I had none of these problems before receiving the infusion. Has anyone had success in losing the weight they gain? Who can help with the jaw pain? And does anyone who has taken the reclast and no longer taking it know how long it takes to get out of your system?
My damage is permanent after one infusion 6 years ago. igA nephropothy diagnosed by biopsy. Muscle/bone pain now comes in spurts but still comes. Horrendous pain unlike regular muscle cramps. Protein in urine immediately after infusion. Now on immune suppressants for the rest of my life. Absolutely ZERO kidney problems before infusion. Get the protein in your urine checked- like immediately. If it is abnormal get to a nephrologist. Mine was doubling every few weeks- with no symptoms. Most people present with kidney failure before they have symptoms. Your doctor sounds like my primary care doctor- pretty much useless- because they don’t want to believe what you are telling them (liability). The damage is real, and this drug should only be prescribed to people who have had multiple fractures and/or bone cancer. There are also defined guidelines which the doctor should test you for before giving it to you (creatinine level, etc).
I had the Reclast infusion on 9/12/2018. Within 1/2 hour of finishing it, a wave of extreme fatigue overcame me. I rode a bus home, and by the time I got to my stop, I had a hard time getting out of my seat to get off the bus. I was dizzy, confused and unsteady on my feet. For the next couple of hours, I wandered around, unable to figure out how to get home. A stranger helped me find my home, and once inside, I immediately went to bed. I woke up three hours later with violent chills and fever. In the next three days, I developed hip pain, stiff neck, and rashes on both lower legs. My hands swelled to the point I could not use then, and they were extremely painful. I developed viral conjunctivitis in my rught eye, but the PA at my doctor’s iffice assured me that was not a side effect. It most certainly is on the list. It has been a week since the infusion, and my legs are both swollen and painful along the veins. Tonight my left eye is very blurry and itchy, and I believe the viral conjunctivitis has infected it also. I feel as though I have aged ten years since I received the infusion, and I had no prior knowledge of the kinds of reactions that could result. Tomorrow I am going back to my doctor’s office for the 4th time since 9/12/2018 because of the lingering side effects. I will never have the infusion again, and maybe not the oral medication either.
I am reading side affects and am so afraid to have this treatment. My Dr said nothing about side effects I was diagnosed with mild Paget’s disease I am 69 yrs old
My Doctor has pressured me to do the reclast, but I am refusing to do it. ALSO, I found a website that tells how much money the manufacturer of this Drug is giving to doctors to promote and pressure people to take the shot. I have done plenty of research and found that Bovine Colostrum will grow NEW bone in humans, and I know this to be the Truth; because new born babies live off of their mother’s milk for one year and sometimes two years. If a new mother’s milk will do this for babies, why can’t Bovine Colostrum do the same thing for humans.
Also, Reclast does not grow new bone, it is suppose to repair bone, but from all of my research, it does more harm than it could ever do good. I will probably have to change doctors, but “it is what it is”. I have been taking the Bovine Powder for about six months now, and I am no longer having hip pain.
Don’t do it….my sister had it done and she is in tears from the pain in her jaws. She had a root canal done on her back tooth thinking that would help…$2000. now she wants that took pulled….$500. on Tues. She lost a lot of weight because of the pain and can’t eat. Dr.’s have been told about reclast and they ignore her pleas for help. I can not believe people are still receiving this stuff….it should be banned and the company sued.
I had Reclast and in three days my neck was stiff and I could barely turn my head without pain. It’s been five days and it’s no better. My doctor says he doesn’t think it’s the Reclast but I’m sure it is. Nothing seems to help the pain.
I was scheduled to get a Reclast infusion tomorrow, so I decided to type in reviews on Reclast. Am I so glad I did. I immediately cancelled my appointment.i noticed there are many more people with terrible side effects than there are people who came out ok. The nurse at the infusion center said her Dr. wanted her to get the infusion, but she is concerned and won’t get it done yet because she feels fine.im going to listen to my mind, not the doctor.
So sorry for everyone that has taken this drug and has all these nasty symptoms.
About a month ago my doctor scheduled me a appointment with oncology for what she said was a once or twice a year infusion. Never said the name. When I got there they took me to a chair and hooked me up. I asked about side effects and they said none. Looks like a little bottle of water. 5 day’s later ended up in er when I couldn’t take the pain anymore. I trusted her. In a follow-up from the er she said that it happens with research drug’s. What does that mean?
I wish someone had told me about the serious side effects reclast can cause
before I agreed taking it . Never assume something is safe just because your
doctor tells you to take it . I just had the infusion and feel like I have the flu. Alot
of body pain and a popping sound in some joints and pain at the same spot. I am so afraid how long this will continue and what else it will cause.
I took the infusion of Reclast about 2 months ago and my body hurts worse now than before, especially my hands and all my joints. Now I’m starting to get headaches and jaw pain with this. I had the Reclast in the morning and by that nigh I thought I was dying, slight temp, body aches, muscle and joint pain, could hardly move or even sit up. This lasted for about 3 days and now it feels like I have a light case of this feeling everyday and I don’t like it at all. So when it comes next March 2019 for me to take it again, so sorry but not this gal. Every person is different that takes this med….
I had it April 2nd; actually nurse tried talking me out of it since I had reaction to fosomax. I had every side affect there was; ran fever; and still have joint pain everyday. I will never take this again
I thought I was going to die the first 3 months.Also feel like there’s things under my skin.And lots of brown spots on my arms .My neuropathy in my feet got so bad I have been to the foot Dr twice horrible pain.Never take it again
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Had Reclast injection 12/21/2017. Two days of severe breathing pain, could not bend forward, lift anything, every breath hurt. It then went to severe headache on left side where injection was, and severe eye socket pain. This continued for 2 days with double vision and eye socket pain on left side. Doctor said go to ER, I did and they admitted me another 2 days. Ran all tests and decided it was Cellulite injection, but I know it was side effect from Reclast, they could not prove it though, seemed they thought so too. I had no elevation of white blood cells, no pain in the redness itself around my eye, just way deep in the eye socket. Never take this again. Still had morning confusion and headache. slight eye pain.
There are so many law suits with the Reclast and so many people are sick from it why is it still being used?
her sats dropped to 47 and me (her daughter) my brother and sister were called as things turned for the worse.she has to go home after a someone in the hospital recommended herbal clinic to us thankfully after three weeks and the shere determination of my mums will to live shes home, she was connected to oxygen 24hours a day, very tired,cant do things for herself. but shes alive!! this is a horrible condition for any human being to have to go thru but i can proudly say she is fully cure of COPD diease,for anyone in this condition must contact (totalcureherbalfoundation gmail com / https:// totalcureherbalfou . wixsite . com/ website)
I had Reclast in 2015,2016 and next month will be time for another one.But, after reading everyone’s story I realized I too have a lot of the same issues w/the bones n bad pains in muscles,pain in Jaw,Jaw popping when I eat.
I had a reclast injection August 17, 2016. Several hours later I was in horrific pain throughout my whole body! I was so weak, dizzy it was awful. I could literally not get out of bed to use the restroom. To this day I have serious joint and muscle aches fatigue and lots of other side effects. The worst one is the lower back pain. This injection was suppose to help me but I feel made my life so much worse. I am doing better now but it has taken a year out of my life! They want to give me another infusion soon and I absolutely will not! I think it does more harm than good.
I had the infusion 12/9/2016 and have not been right since. Constant pain in my neck, shoulders, arms hands and now hips. The VA wants me to continue to take Prednisone and I don’t want to because that only hurts my bones more and takes away from my strength. I will NEVER take anything like this again. And I just want someone to give me something to take away the pain I am in 24 hrs a day
June, 2012 I received my third and final injection of Reclast. This drug has destroyed my life. I live with daily bone pain and have gone through major eye surgery because of this drug. It has been 5 years…will it ever go away?
Hi Mary, I can so sympathize with you! I took Reclast 5 weeks ago after a hip op and it has nearly killed me. It’s been worse than any chemo I ever had for breast cancer and I wish I had never taken it. Also having big eye problems, all I can pray is that it will get out of my system quickly and the side effects will settle down. How they can give you a drug that stays in your system for so long is unbelievable, what happens if you have a severe reaction, it’s not like you can just stop it!
Thank you Reclast,
I have taken Reclast for four years. I had an a typicle femur fracture which in the end became a complete femur fracture. Drs say it was from taking Reclast.
This happened January 20, 2019 and I am still on toe touch as of April 6, 2019
I was totally unaware that is is a side effect.
It never leaves your system.
Hi, Mary, sorry to know about your condition and wishing you quick recovery.
My mother took aclasta for 3 consecutive years. After taking medicine she used to have fever and little pain but she was fine. Last year she didn’t take the medicine and now she is complaining a lot about pain in back and in legs.
So now, I am confused and thinking to start aclasta again – can you please guide – shall I start and who can better guide in this scenario.
Thanks and take care!
Mine has not gone away. One infusion 6 years aago- permanent damage. One step away from total kidney failure. Immune suppressants for the rest of my life.
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June 20, 2017. Had reclast at 1:00pm. Woke up at 6:00pm with pain, temperature of 102 degrees. Pain so bad I could not get out of bed, had to call my daughter to help me, the manager had to unlock my door because I could not get up, CHILLS and blood pressure went real low. Daughter called 911 they took me to the hospital and pumped me full of steroids because of the reaction, this horrible medication is in my body for a year, still having pain. I want this reclast to be out of my body. What to do?
I am a 57 year old woman who received the reclasp infusion on 11/8/17. I have a history of osteoporosis & fractured my back this past summer. I have already tried the shot form of treatments a number of years ago. Because of digestive issues I am unable to do the pill form of treatment. I received the infusion in the morning & by late afternoon early evening I was beginning to ache. My wrists & forearms especially were bad. I wasn’t to concerned because I was told that could be a side effect. However at around 1 am I was woke up to severe abdominal pain, rib, hip, & back pain making it difficult to even taken in a decent breath!! Those symptoms I was not told about. I wish I had know of this site before the infusion. Or thought to check this medication out a little deeper before agreeing to the infusion. I had an uneasy feeling about the medication the whole time & didn’t go with my gut! Now I’m paying for it!
People, do NOT get the RECLAST INFUSION! My best friend got the infusion in the middle of April (2017). She was fine that evening and thought she would be one of the lucky ones that suffered no side effects. BUT…by 2:30 in the morning, she could not move. She had to wake her husband up to ask for help in getting to the bathroom because the joint pain was so excruciating. Now, she is walking with a cane and has seen NO IMPROVEMENT in her symptoms and it is 7 weeks later. She has had at least 20 viles of blood taken from her for tests, she’s had muscle and nerve tests done, she’s had an MRI and CT scan, and this week she will be paying her second visit to the neurologist and also seeing a rheumatologist. Her balance is way off, and now the doctors are thinking the Reclast may have caused severe nerve damage. She is in the middle of a nightmare right now, and she can’t wake up. This is a woman (turning 60 next month) who has always been active, walks, exercises, loves to bake, and rides her bike everywhere. Now, all she can do is sit in her chair and watch TV or read. She is beside herself with angst over this development. All because of RECLAST! Today she said she would’ve rather had osteoporosis than this. Doctors see no end in sight. They have no timeline and can’t even guarantee she will ever return to normal.
DO NOT GET A RECLAST INFUSION!
I had a Reclast infusion over three weeks ago and am still having side effects from it. Like others, I have the severe aches in my body, morning confusion, fever that now comes and goes every couple of days. 6 hours after the infusion I couldn’t move and my fever shot up to over 102 degrees. I have continued to have migraine headaches for days. I wish I had never touched this drug. I don’t know how to get this poison out of my body. Please, don’t let your doctor talk you into having this medication!
Is your friend still experiencing these symptoms? My mother in law has experienced the same as you described. It is horrible! She was still working as a beautician up on her feet 10 plus hours a day and very independent. After recast she needs a walker to even get around her home. She has severe neuropathy and cannot sleep more than a couple of hours due to severe pain and spasms. I hate seeing her so pitiful! Has anything helped?
I took my first infusion of reclast in Oct. of 2014. I had no problems. The next year after my next infusion on my birthday (what a horrible present) I had hot sweats, chills & fever, red eye, headache, bone ache, horrible feelings around my elbows, wrists, ankles. It would come in waves. At first at night in the middle of my sleep & sometimes during the day. Sometimes uncontrolled shaking., pain in my back, fear of emminant death,. Went to ER & Dr. They thought I was crazy. One put me on steroids which made me worse. After the first 3 months things gradually got better, but I still wake up with the craziness in my elbows, wrists & ankles. Lately it’s getting worse. DON’T TAKE RECLAST, PLEASE!!! It’s the worst thing I’ve ever experienced in my life. I’ve counted 31 reactions including in my mouth, spots on my tongue, feeling like my theoat is swelling, etc. I’ve worked thru it these past 3 years with exercise, lots of water & lots of prayer. The company who put this on the market & the FDA need to be severely penalized for causing so many of us to be in such horrible shape because of taking a drug that’s almost worse than torture by poisoning!!! Praying for all of us & an antidote also. God be with us. I knew in my heart of hearts before I took it to say NO, NO, NO!!!