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Reclast Research Info (aka Zoledronic Acid-Novartis)

windblown
7 Recommendations

Since so many of you have been asking about the Reclast, and Zometa infusions, I thought I would post the New England Journal of Medicine's article on Zoledronic Acid (Reclast), the once yearly infusion for post menopausal osteoporotic patients.

The article is pretty straight forward and should be easy to read. I hope this helps many in answering your questions on side effects, benefits, etc.

This drug has been on the market for 5 years but primarily used for bone cancer patients, those with hypercalcemia and Paget's disease.

http://content.nejm.org/cgi/content/full/356/18/1809

Brand Names of this drug:

  • Zometa
  • Reclast
  • Aclasta
  • Zometa Concentrate

Explore topics in this discussion:

Exercise Cancer Surgery Back pain Degenerative disc disease Osteoporosis Osteonecrosis Zoledronic acid Forteo GERD Stroke Fosamax Reclast Actonel Pain Heart attack Bone cancer Depression

47 replies

windblown

Thanks Sandi for the Info, I'll try that. Just to clarify, was the 50 pages from just "one" Drug Co/drug?

It would be really helpful for me to get one of these from each of the various osteoporosis drug manufacturers on each of the different drugs.

Thanks again... Hope you are well!!

sdivas

Windblown, good information. Also, the pharmaceutical companies that I have spoken with are also interested in hearing about side effects. The information that is available on these meds is not difficult to receive. I recently requested up to date information from a pharmaceutical and was sent 50 pages. With notebook in hand, it is an easy way to list the differences between the meds; and if meds are the choice, it is easier to make a decision noting one med from the other. Sandi

windblown

To All who experienced adverse side effects from this, have you reported it to the FDA? If not here's the info for this. It will help others down the road to give this info to the FDA.

You are encouraged to report negative side effects of prescription drugs to the FDA Visit www.fda.gov/medwatch or call 1-800-FDA-1088

windblown

Hi Zeta, thanks for the links on Zometa. I'm not taking Reclast and have no plans to do so, but posted this in the hopes it would give others some further info. There has been a lot of info on Zoledronic acid that has been reported by the FDA/NEJM since I posted that 2007 NEJM article.

I think the most important thing is for all of us to read as much as we can on any drug before making a decision to take it. Novartis did include the info/precaution on renal toxicity in their ISI, on Reclast, but unless you are really good at reading that type of thing you might have missed the mortality info included. The FDA has a pdf on this very topic explaining the #'s of patients that had renal failure or worsening renal disorders, but you have to look for it, since Novartis doesn't go into great detail on it. As I said they do mention it, but it's easy to miss in their ISI (Important Safety Info) at the bottom of their web site.

Good luck to all and please do educate yourselves even if the language can be hard to understand. With a little help, you can figure it out (dictionaries).

I prefer to read the Dr.'s prescribing info (in pdf) provided at the Drug web sites (all of them), since usually nothing is left out (or I hope not). :(

zeta

Thanks windblown for the NEJM article. I do have a couple of links that emphasis adverse reactions to reclast however, that seem pertinent to this discussion. But, I hope you benefit from the drug and don't experience any problems.

Here follows the information which takes a different perspective:

http://healthcarereform.nejm.org/?p=2126&query=TOC


For example here is an excerpt:

"Sometimes what gets lost is data on harms. For example, in 2001, Zometa (zoledronic acid, Novartis) was approved for use in patients with hypercalcemia of malignancy. Approval was based on the results of two trials,1 in which 287 patients with cancer were randomly assigned to receive either 4-mg or 8-mg doses of Zometa or Aredia (pamidronate), the standard of care. According to the label, 8 mg of Zometa was no more effective than 4 mg in reducing calcium levels but had greater renal toxicity (see box on Zometa data). The numbers quantifying the renal-toxicity data for the 8-mg dose did not appear in the label, as they did for the 4-mg dose. But they did appear in the 98 pages of FDA medical and statistical reviews. Surprisingly, the reviews also noted that the 8-mg dose was associated with a higher rate
of death from any cause than the 4-mg dose (P=0.03). These mortality data also did not appear in the label. Nor did they appear in the journal article reporting on these studies,2 which actually recommended the 8-mg dose for refractory cases. In 2008, the FDA approved an updated Zometa label with an explicit warning statement: “Renal toxicity may be greater in patients with renal impairment. Do not use doses greater than 4 mg.” Yet the mortality data are still missing from the label."


Furthermore:
This recent court verdict on Zometa strikes me as a companion piece to the fist one I posted above:


http://www.missoulian.com/news/local/article_5925bf88-be6d-11de-bc95-001cc4 c03286.html

"Jurors slapped a Swiss pharmaceutical company with a $3.2 million verdict Wednesday, wrapping up a Missoula woman's lawsuit that will have bearing on hundreds of cases against the company nationwide.

The jury of six men and six women received the case Tuesday afternoon and
deliberated for six hours before retiring for the evening. The panel reconvened Wednesday morning and reached a verdict after less than two hours.

The case, tried over five days, involves claims by Peggy L. Stevens, 57, of Missoula. She filed suit against Novartis Pharmaceuticals Corp. last year, alleging the company was professionally negligent when it failed to disclose health risks associated with one of its medications, a bone-strengthening drug called Zometa.

Stevens has lymphoma and developed serious dental and jaw-related problems after taking the drug for several years. Her attorneys say the company knew patients taking Zometa were vulnerable to a degenerative jaw disorder called osteonecrosis, particularly those patients who undergo invasive dental procedures

zeta

BW

I am not witholding information. I have written numerous times on the discussion of hair loss and Reclast. I took my second IV of Reclast in June of 09. Nine days later, my hair started to fall out. I have very thick curly hair, so the loss isn't as noticeable to most people, but I have lost about 1/3 of what I had. It has slowed somewhat, so I am hoping it will stop soon. New hair is starting to grow in. I also developed heart palpitations which have since become less. I will not take the drug again, although it did work in building bones.

Champy

Withholding details that other people could use for making an informed opinion is not a good idea BW. Please share your complications - You might help someone.

BW

I had very bad scores - -4.3 in the spine and -4.5 in the hips. With a combination of Forteo and Reclast, I am now osteopena. No side effects after the first dose of Reclast, so I enthusiastically did a second round a year later. The second dose gave me me complications. Without going into details, I would not take Reclast again. It is different with everyone and reacts differently every time you take it.

Champy

Hello Windblown. I am not insured, but we have public healthcare in Denmark and diseases like osteoporosis is given a subsidy, so Reclast is totally free for me. With Forteo I paid a symbolic price (I think we're talking 5% of what 18 months usually costs) and the Danish health care system took care of the rest. I can't complain.

PoppePam

Thank you for posting this as I have been trying to decide the pro's and con's of the infusion ever since it was recommended. I am already on Fosamax and have had my first Osteo-related break, ribs. The information is very helpful.

windblown

Hi Champy, glad your doing well on this. I was just curious, does your insurance cover this infusion? I hope so. I have a friend in Canada that's trying to get this set up and she hasn't found out yet where to get it or how much it will cost. Anyway so glad you did well.

Good luck with this and keep us posted on how you do.

Champy

Also wanted to bump this one. I had my first Reclast/Aclasta infusion this summer and had 1-2 days of flu like symptoms and muscle and joint soreness. Been fine ever since, and I can't wait to get scanned again in january 2010 to see progress (if any)

I feel for those with very bad side-effects but as noted above it's been a breeze for me. I was previously on Forteo for 18 months (Maximum allowed time in Denmark, as opposed to the 24 months in the US)

millie123

I thought I would bump this one up. It started more than a year ago, but those of you new to the forum might benefit from reading this discussion.

pichulita

I'm a 59 year old woman who has osteoporosis but, for now, I don't have any symptoms from it. My general health is very good....no aches or pain...yet. The Actonel gave me a ton of stomach ulcers so I stopped taking it a couple of years ago. (I ended up with a lot of scar tissue from these ulcers) My rheumatologist wants me to take the Reclast infusion but I am very concerned that it may give me bad side effects that I may have to deal with for a long time or forever. In reading the discussions I find that some people do end up with very bad side effects, but I'm wondering....WERE THESE PEOPLE MORE PRONE TO GET THESE BAD SIDE EFFECTS BECAUSE THEY WERE ALREADY SUFFERING FROM SYMPTOMS OF THEIR OSTEOPOROSIS? (degenerative joints, aches, pain, etc) I would appreciate any comments on this.

windblown

Hi Sunstateshirley, Don't quote me on this, but I've heard that Reclast costs apprx 1,000.00. There would also be some other charges for the infusion too. It's too bad your insurance can't tell you how much it will cost. Don't they just charge you whatever your copay might be? You could try calling Novartis, but I don't know if they will tell you this since all insurances cover it differently. Make sure they test your calcium and creatininie clearance before the infusion. You can read about this on the Novartis site under Important Safety Information

Good luck...

tallygirl

(sorry too wordy) ...join those who legitimately have had the "debilitating bone and joint pain." Reclast may be great for some, but just be aware that these side effects DO occur for others of us. Good luck.

tallygirl

I was the first one in my city to have the Reclase injection 11/07. I had a few days of flu-like symptoms but after that passed it did not seem as if there were any side effects. My second injection was 11/08 and the flu symptoms were even less. Exactly one week after the injection however, (on Thanksgiving morning), I woke up with severe lower back pain. Within 2 days I required assistance sitting down and standing up. This lasted for about a week. Since that time, I have had severe, sometimes debilitating pain in different parts of my body, particularly affecting my left side. It has traveled from the left leg (mid area from just below to knee to just above the knee) into my shoulders. Most of the pain will subside after awhile except in the left leg. This pain is getting worse. I cannot stand on it or walk very long without having to rest it. My Dr. is very thorough and has testing for just about everything since last November. Cortisone shots helped but only temporarily. An x-ray showed nothing but an MRI is next. Now my ankles are swollen almost daily. If it weren't for hydrocodone and a heating pad, I would not able to do anything! I can't exercise and it has definitely affected my quality of life. I don't WANT to be a naysayer, I wanted this to work. But facts are facts. I am an otherwise healthy 49 year old woman who had an adverse reaction and join those who legitimately

Milford

I first contacted Inspire after my infusion on Nov.17. I had extreme pain,bone, muscle and joint, blurred vision, Atrial fibrilation,balance problems,sores on my skin and in my mouth, disturbed sleep,and exhaustion to name some !! Nothing seemed to help. It seemed endless. On May 15 The pain in my knees, the left one was the worst,was so bad I went to my orthopedist and after an xray that showed no problem, injected cortisone in the left knee. The pain in that knee disappeared and the next day BOTH knees were perfect. As the cortisone worked through my system ALL the pain everywhere went away !! I had 20 wonderful painfree days and then the pain returned. Since I could not have more cortisone for 3 months, my doctor thought we should try depomedrol. He said if IT helped I could get an injection whenever I needed it. Well, it is not quite as good as the cortisone but has truly been a blessing. As of now the only pain remaining is in my face.
I hope this information can be of help to someone. One doctor said I might have this the rest of my life. I was hoping that when the year was up it would go away !!
I have campaigned against Reclast by telling my story to womens' groups and many have cancelled appointments. Maybe I have saved a few from 9 months of pain. Milford

sunstateshirley

My 97 year old Mother has had the RECLAST infusion twice already and did not have any negative side effects. In November she will have her third at age 98. She has
Medicare and Medicaid and so she paid nothing. I am finishing the 2 year Forteo injection program. I am trying to find out what my cost will be with my United Health Care "Evercare" Insurance and can't get any clear answer. Anybody know the cost of Reclast?

windblown

Hi MaryBeth, glad you did well with the Reclast and only had the 5 days of problems. Good luck, I hope it works well.

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