Reclast Warning Issued

Karen,

If you or someone you care about is using the osteoporosis drug Reclast, please read the alert below. This medication has been linked to serious kidney damage.

On October 12, 2010, presumably at the behest of the Canadian govenment, Novartis, the maker of the osteoporosis-infusion drug zoledronic acid (known as Reclast in the U.S. and Aclasta in Canada) sent Canadian health professionals and patients letters warning them of the possibility of kidney toxicity with use of the drug.

Since Novartis did not send similar letters to U.S. health professionals and patients, we are providing our readers with the information sent to Canadian doctors and consumers. We also urged the FDA to require Novartis to issue these warnings to U.S. doctors and patients.

As of April 2010, Novartis had received 265 reports of kidney damage after consumers used Reclast. The true number of patients whose kidneys have been harmed is likely far greater, as only a small percentage of adverse events are ever reported.

Renal failure requiring dialysis or with a fatal outcome has occured. The elderly, those taking drugs that had the potential to damage kidneys, and those on diuretics or who experienced dehydration after Reclast administration were found to be most at risk.

What You Should Do
Novartis provided the following guidance for consumers:

“Before you take [Reclast], talk to your doctor or pharmacist if you have, or used to have, a kidney problem.”
“Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including any you have bought without a prescription. It is especially important for your doctor to know if you are taking any medicines known to be potentially harmful to the kidneys (such as nonsteroidal anti-inflammatory drugs (NSAIDs)).”
“Make sure that you drink a sufficient amount of water (at least two glasses or 500 mL) before and after your treatment with [Reclast].”
“[Reclast's] infusion should take a minimum of 15 minutes.”
Read the full letter for health professionals and the full letter for consumers.

View all of WorstPills.org’s resources on Reclast.

If you are currently being treated with Reclast, you should consider discussing alternative treatments with your physician. Possible alternatives include lifestyle changes and the medications alendronate (FOSAMAX) and risedronate (ACTONEL).

Do not discontinue use of any medication without consulting your physician first.

Sincerely,

Sidney Wolfe, M.D.
Editor, WorstPills.org

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23 replies. Join the discussion

Thanks KMFDallas, I read this earlier today, but glad you posted it here. Scary!

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Eventually this nasty drug will be taken off the market; in the meantime, at least Sidney Wolf is issuing that alert here in the U.S.

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I am so glad to see this posting of the Reclast warning. I went through so much misery from Reclast and would do anything to warn others of the dangers. Thank you, Dr. Wolfe.

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Again the Canadian Government is leading the way showing the "guts" that the US - FDA can not and will not muster !
HealthCanada has some excellent exercise CDs and preventive material on Osteoporosis that they will gladly send out (free of charge and duty free) to their less fortunate brethen south of their border. Just google-- the Province of Quebec is a great starting point!

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Honestly, it is inconceivable to allow this drug to remain on the market in any country; i know that osteoporosis is a bad thing to have; we are all scared, but , good Lord, it it worth your life to take a drug that is so toxic to your kidneys that it can result in death??

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Hi KMF Dallas

Thank you for this information about Reclast/Aclasta in UK.

When I was first diagnosed after breaking my wrists, the osteoporosis clinic staff suggested that I have this infusion because of my history of bleeding gut ulcers. Fortunately my dentist told me not to even consider it, because of the increased danger of necrosis of the jaw, which is not as rare as the doctors like to make out.

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Thank you for this information. My doctor wanted me to try it, I refused and I am taking " Doctorr's Best Strontium Bone Maker. Is anyone taking it and can tell me how they like it?

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Yes, thank you for this information. Ive taken Reclast one time and will be due for my next injection in the end of april. Ive already told them no thanks and this is how I feel with all the drugs the pharmacy or Doctors are recommending. They also want me to start the drug Forteo 3 months ago. Well Im not totally sure but I Believe it said in the directions not to use Fortio while on another kidney straining drug. Ive been on boniva for 3+ yrs and actonel for 2yrs and Ive gotten worse on all the drugs and thats what I hear most of the time that people are not getting better on any drug but just haveing more side effects with no benefits. Id really like to hear from someone who has gone with vitamins and eating a correct diet to help them achieve the results to heal their osteoporosis.??? Their is more and more new vitamins out there. YOU need to get your PH levels right, and exercise, which I lack in. And eat a good diet with taking good vitamins. We need a natural physician to respond and we need more of them all over. God Bless Everyone!!!

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Dear KMFDallas, first of all, it is very rare that we have someone identify themselves as being a real doctor on this site. It is a blessing beyond belief to have this information to be once told finally instead of it again being withheld from those of us that have had this poision placed in our veins without proper notice to make an informed decision. So sad for many of us that found ourselves in my worse shape than before Reclast treatment. The side effects are tremendous to the body. Unfortunatlly we are having problems with persons stating factual information, that is not correct, which only confuses other sufferers. So again I applaude you for taking your time to update us with important information. We are praying for the day, when Reclast is taken OFF the market, and there are no more terrible surprises to the patient infected with this drug. If there are actual cases where they been patients that are side effect free, what a true Blessing that would be for them, I just hate most of us did not have a good of outcome, and are now faced with lingering mounting issues, that do not stop or go away. Thank you again for you expertise on the subject matter.

Respectfully,

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thank you thank you for sharing this info.
I met with my NP and she does not recommend any of the BP's. Now I wait until I see her on the 29th to go over my many blood tests to see exactly what I need to fight and reverse the osteo. She uses the Strantium Citrate and has had good results, but I don't know right now what she will suggest that I take.

The radiologist has cancelled my thryroid uptake test three times so far due to the lack of the nuclear iodine that pills that I need to take 6 hours before the test. Hopefully It will be here tonight, so I can do it tomorrow.
this med comes from a plant in Colorado. I hope it is soon, for I have had to be off my thyroid meds. for almost 5 weeks now and I am beginning to get hyper and weary too.
this shortage took place before the horrible disaster in Japan, and our local lab does not know why.
Interesting?
Have a great rest of the week!
We think our big snow days are past! YEAH! We appreciate the moisture!

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What a blessing it would be to see this horrible drug go by the wayside. But would the FDA admit that they were wrong? I highly doubt that they would step up and admit that. They would have a heck of a lot of crow to eat. In the meantime, there are a lot of susceptible people that may take this horrible drug. So we all need to be on our toes and step up and tell our stories when need be so that we can hopefully prevent as many as possible from suffering like we are from this horrible drug.

Our job is not done until this drug is removed from the market. We cannot rest. We cannot let our suffering from this drug be for naught. Each day when I awake in pain, I know that I must make that pain be for a reason. That reason is to make it so that someone else doesn't have to go through what I am going through. So I tell my story again and again. With each word, I hope that I can save someone from the pain....

So, here goes... for anyone out there that hasn't heard my story, I took this drug on May 27, 2010, almost 9 months ago. Since that time, I have suffered atrial fibrilation, to which I had to undergo a cardiac ablation, which was unsuccessful (an $86,000 surgery); 50-60 bone spurs that are on my spine, hips, hands, ribs, and even six in my lungs; gastroparesis; an electrolyte imbalance which has caused my white count to be way out of line to the point that I am susceptible to infections and have caught pneumonia twice this winter and have had to be hospitalized (once I almost died - my blood pressure upon admission was 46/20) and a bout of the flu that I also had to be hospitalized and again was close to death; my weight dropped down to 89 pounds and I had to have a feeding tube inserted, but due to my white count, I got an infection around the feeding tube and it had to be removed and I again was hospitalized. My white count was critical the whole time I was hospitalized so I was in isolation nearly the whole week I was in the hospital. They still have been unable to get my electrolytes in balance so I have to be really careful where I go or who I am around so I don't get sick. My weight has dropped back down to 101.5 pounds, after it had risen to 111 with the feeding tube. I eat regularly but I am unable to maintain my weight. I don't want to go back on a feeding tube and will resist it when I go back to Iowa City on the 30th, but I don't know if I will have a choice.

So, hopefully, if anyone is trying to make a choice with regard to Reclast, I hope you will decide to go another direction. If you don't, that is your choice. I know there is a 2 out of 100 chance that you may have a reaction to the drug; however, what they don't tell you is that if you have any one of the many conditions listed in the FDA's brochure, your chances are cut considerably. They don't give you that brochure when you are getting the drug, all they give you is the one that says all you need to do is drink plenty of water and that you may experience flu like symptoms or on the outside chance you may have jaw necrosis. Have you seen the pictures of jaw necrosis? If not, google it and see it. Then decide if you want that outside chance! What you are doing is playing Russian Roulette with your life! You can have any number of things happen to you. Look up the last day's of a woman as told by her husband as she died from Reclast. (I can't remember what the title was but he told the story of his wife as she passed away from perfect health. It was one of the saddest stories many of us had ever heard.) Or look up Swampqueen's story on the passing of her mom. She looks across the hall at an empty bed every day.) These are sobering stories.

Well, I'll get off my soapbox now. But I just wanted to add my 2 cents worth to this discussion.

CubbieFan2308

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Thank you CubbieFan2308 for sharing your story. I remember your posts and reactions to this drug. I wish you well and a return to good health you my friend. Will the FDA apologize for this drug........NO they won't. As many of you may know, I am a DES daughter and have been a supporter for the DES exposed, their health care, research and education of healthcare providers. It's been a long journey. 40 years since DES was found to cause cancer first in the DES daughters and now breast cancer in DES mothers. My group DES Info worked closely with the two senators from Massachusetts to get an apology from the FDA. Well, in February, the FDA wrote to the Senators and called it the "DES Tragedy"....no apology. We are awaiting an apology from the drug companies, but they are too busy with direct to consumer marketing, improving their bottom line and proudly boasting their focus on quality and patient safety via the National Quality Forum. The pain and suffering for those who have taken Reclast is growing. Sharing your stories and getting the word out is so important. Keep spreading the word

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KFMDallas:

I am so sorry about everything you've had to deal w/with regard to the FDA. They will never apologize because in their eyes that will open them up for a lawsuit. Thanks for your kind comments. You're right that we need to keep the word out there until this drug is off the market.

You take care!

CubbieFan2308

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I posted earlier about the effects of Reclast on me, I had absolutely terrible pain and ended up in a chair for 2-1/2 years. After reading that an asthmatic should not be given this, I think that is why my asthma worsened so much. I had several bouts with pneumonia, plus I was also hospitalized with a blood clot last year. I am sure that my stomach problems were because of Reclast. I was put on Vicodin (half tablet) every four hours for the pain, because in the last few months, the pain worsened tremendously before it got better. After taking the Vicodin, which I fought taking, but It helped so much. Any time I was free of pain, I moved my legs as much as I could. I used to have to take a pain pill and wait for it to work before I could get out of bed in the morning. Slowly, I noticed that I was able to move a little more, it started out by using my walking for a short time in the early afternoon. I then woke up one morning and was able to get out of bed without a pain pill. I haven't taken any pain pills in probably 6 weeks now, I have stopped using the walker and the cane and I work on getting back everything I lost every day. My allergies have improved and I don't need as much stomach medicine as I used to. My doctor thinks the Reclast has finally gotten out of my stystem. I had so many fractures and I wonder if, because I was told Reclast coats the bones, if it entered all the fracture sites and that is why I had so much of it in my system. I just wanted to give hope that maybe things will get better for all of you, like it did for me. You are all in my prayers.

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I have taken Reclast and I don't have necrosis but my teeth will ache so bad sometimes it brings me to tears, feels like someone "struck a nerve" but literally. I have massive stomach issues so was wondering what you take for osteo. Thanks, Deb

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Hi Else

I have been taking Dr's Best Strontium citrate for over a month now. I originally wanted strontium ranelate (protelos) but the doctor wouldn't let me have it on grounds of cost. I stopped the alendronic acid which she prescribed, after about 10 weeks. I started getting mild bone pains and I was afraid of other potential side affects starting. I had seen the Dr's Best mentioned on both forums ( the UK National Osteo. Society) so ordered some.

I am still getting the bone pains, but no other side affects. I don't know whether the pains would equate to the 'growing pains' that kids get. Perhaps its a good sign that some activity is taking place in my bones? I really have no idea! I also don't know whether the pain is due to the alendronic acid, which I believe can stay in your system for a long time, or the strontium citrate working.

I would be happy to continue with Dr's Best Bone Maker, except for a couple of minor points: I broke my wrists 2 weeks before we should have gone to Yellowstone NP for a photographic holiday. Saga Insurance paid up for both of us and allowed us to renew the yearly insurance, PROVIDED I WAS TAKING PRESCRIPTION MEDICATION FOR THE OSTEOPOROSIS. Now that I have stopped the alendronic acid I am worried about going abroad incase I have another fall, as my insurance wouldn't cover me. This is causing problems at home because my husband is desperate to book another holiday to make up for the one we lost last year.

Both strontiums carry the slightly increased risk of DVT. I read that if you go on a long haul flight you must stop the strontium at least 12 days before you are due to fly. I am still hoping to get the prescription strontium which at least will sort the insurance out.

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"Both strontiums carry the slightly increased risk of DVT. I read that if you go on a long haul flight you must stop the strontium at least 12 days before you are due to fly."

And I've heard that there's less chance of DVT with strontium than with, say, Evista (which I took at one point), and I didn't have to stop my Evista before flying. I *did*, however, make sure that I got out of my seat every hour and did the recommended foot movements while sitting. I would do the same with strontium.

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Hello Lyn H
I read your reply with great interrest. So far I am doing good with Doctors'BEST Strontium Bone Maker. Before I started it I had lots of pain. I was recovering from spraining my upper back and lower. I had a mild anterior compression of T9 T11. So the pain I still have is very mild compare from before. However what I do notice since I am taking Strontium ,my knees don't hurt anymore.
I hope all turns out well for you and you can go on your trip. Yellowstone is so beautiful. sure will take the advise when flying.
Thanks again for your article.

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I have decided not to continue on Actonel and taking supplements and exercise

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Thank You Cubbie Fan for the work you are doing in warning others of Reclast. I am grateful every day that you shared your terrible experience with us and I hope and pray that you will recover fullysoon. My heart goes out to all who have had these tragic consequences from Reclast. A friend of mine had the infusion early this year and she is doing fine. She had suggested it for me but your story dissuaded me. I warned her to do the research before taking another one as some didn't have horrible reactions until the subsequent infusions.
God bless and keep you.
Mcmymm

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