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    Old 08-19-2007, 08:59 AM   #1
    hypatia
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    Reclast approved by FDA

    It was announced recently that the Novartis drug Reclast, which is a once-a-year infusion, has been approved by the FDA. According to the study, a small percent (1.3) of those receiving the drug experienced atrial fibrillation. Reclast (zoledronic acid) is already being used for Paget's disease patients.

    I need to do way more research, but this sounds like a good alternative to the bisphosphonates and I like the idea of one injection a year. Unfortunately, every drug seems to have side effects.

     
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    Old 08-19-2007, 09:32 AM   #2
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    Re: Reclast approved by FDA

    Hi Hypatia: Unfortunately Reclast is a bisphosphonate, and one of the stronger ones. It's been marketed before as Zometa for cancer treatment and used for Pagets disease as well. It has been included in the class action suit against bisphosphonates and Merck. It's also one of the nitrogenous ones that are really strong


    Here's just a short list of bisphosphonates to date: etidronate (Didronel), pamidronate (Aredia), alendronate (Fosamax), risedronate (Actonel), zoledronate (Zometa or Reclast), ibandronate (Boniva)


    So sorry if you were looking for a non bisphosphonate iv drug. So far all the iv drugs are stronger forms of the oral bisphos's. Maybe in the future there will be something other than bisphos's but right now we are stuck with them.

    Last edited by DesertBloom; 08-19-2007 at 09:53 AM.

     
    Old 08-19-2007, 09:43 AM   #3
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    Re: Reclast approved by FDA

    Thanks for the clarification, DesertBloom. I knew I could count on your input--and I should have known it seemed too good to be true.

     
    Old 08-19-2007, 10:49 AM   #4
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    Re: Reclast approved by FDA

    Hi Hypatia: No problem, but I really feel for you and the rest of us. I'm having some dental probs right now, and they aren't unusual ones at that. I have many crowns from root canals which of course was a way to save my teeth over the years, and I'm finding out that those crowns have reached their end of life. Once this happens and it can for anyone your only solution is extraction.

    I only took Actonel for 13 mos and have been off of it for over a year, and I am having trouble finding a dentist/oral surgeon who will pull the tooth. I don't have any symptoms of osteonecrosis, loose teeth, exposed bone, ulcerations etc. but they are still afraid to touch me. If you looked at my teeth you wouldn't think I had any problems, just old crowns

    Unfortunately some of the crowns can't be reattached because the tooth has aged and there is nothing to anchor the new crown to.

    Righ now I have a horrible tooth ache, and am trying to figure out what to do. My dentist doesn't know anything about osteonecrosis, and doesn't believe it's an issue but won't pull the tooth without a release from my primary care dr. So my pc has given her release, but "only" if they agree to follow me afterwards for osteonecrosis. The dentist doesn't have the faintest clue how to do that and besides there is NO treatment for ONJ anyway.

    Oh well that's enough belly aching, good luck to you and I hope some new NON bisphosphonates appear real soon!!!

     
    Old 08-19-2007, 01:05 PM   #5
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    Re: Reclast approved by FDA

    Desert Bloom, would you consider a new dentist? Sorry about the toothache. It's miserable!

     
    Old 08-19-2007, 01:22 PM   #6
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    Re: Reclast approved by FDA

    Hi Rosegarden: How are you??? How's the forteo going??

    Yes I would definitely consider a new dentist, but I have an HMO, which only let's me go to the one I have. I can't change dentists until next April when my contract is up. I do have an Oral surgeon who knows plenty about ONJ, and will "consider" pulling my tooth, but I will have to pay cash for it. I actually have 2 teeth with the same problem, and when I saw the oral surgeon months ago, he said he would consider the extraction, but only as a last resort, meaning when the tooth started to hurt real bad or became infected (which seems ridiculous to me).

    The teeth are not abcessed, but 'one' is decayed and I'm also worried about sepsis getting into my blood stream. I also have MVP (mitral valve prolaspe) so I have to premedicated prior to any dental procedure so I'm at risk for heart probs (infections) because of that.

    I can't get into see the oral surgeon until the 2nd week of Sept, so we'll see what happens then. The oral surgeons brother is my Endo, so between the 2 they know alot about ONJ. I'm just afraid he's going to put me off again on the extraction. This oral surgeon has had 2 patients that had ONJ, and both got it from the iv bisphos's, but he believes that it doesn't matter whether you took it orally or intravenously it's still a major prob. with no cure. He also doesn't believe a drug holiday will help any either, so it's very depressing to talk to him. His thinking is once the drug is in the bone it's there for a long time.

    I guess I can wait till Sept and see what he will do, and start the whole process over again about getting a release from my pc for the oral surgeon to pull at least one of the teeth, but that still leaves the second one, which isn't hurting too bad yet. I'm worried about the hole in my mouth getting infected, since food gets caught in there everytime I eat. I'm doing what I can to keep it clean, and I'm on a cancellation list at the oral surg. for an earlier appt.

    Anyway that was a long explanation just to tell you that yes I would see someone else, I'll just have to pay for it, and at the moment I have no idea what the price will be since it could turn into major post op monitoring.

     
    Old 08-19-2007, 01:34 PM   #7
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    Re: Reclast approved by FDA

    DesertBloom, I have been following your teeth issues and your posts. I so sympathize with you. I am having my third extraction in two months tomorrow and possibly a fourth - all due to root canals and surgical root canals that lasted five years at the most!!! So frustrating and so, so much pain as they have all been infected beneath the crowns. I can't imagine not being able to get these extracted and being in the situation you are in. And, I was very sad to hear that you are now experiencing pain. Believe me, I so know what that is like. Another dentist might be an option, but if you do I would certainly tell them of your past history with Actonel. While many dentists are becoming more informed, there are still many who do not know. I plan on alerting mine tomorrow - not that I took them, but to help other woman along the way. You have my deepest sympathy with your toothache and I hope you can find some resolution soon. It is most taxing to live with pain day after day. I refuse to take the narcotic pain medications - they just make me feel spacey and awful and I don't need to trade one problem for another - addiction vs tooth pain. So, Motrin has become a friend although not a total friend!!! Try rinsing your mouth with warm water (it does help), use a heating pad or ice whichever makes you feel better, and treat your mouth gently with easy foods and trying to get your mouth to relax - just keep telling it to relax, you can feel the muscles relax. I am thinking of you and so sorry that when we try to fix one problem we get another. How I wish there were easier answers and doctors/drug companies that could get it right!

    glowing4

     
    Old 08-19-2007, 01:34 PM   #8
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    Re: Reclast approved by FDA

    Desert bloom
    Is there a website that I can find the information about the class action lawsuit against Merck? Why isn't there one against the other bisphos companies? My new doctor says that the studies(of which he was a researcher in) between placebo and bispho patients show no difference in the incidence of ONJ and other dental problems, and that the dentists are overreacting in general without any real reason. I would like to read about the suit. My next step is a bisphos-either fosamax or actonel very short term. He told me I could take the 35mg dose of fosamax instead of the 70 if I wanted to. I haven't filled the scrip yet, and it's only been 6 days since I stopped the Forteo. I have been told that I have protection from forteo for about a month or so. I should make a decision in the next few weeks.
    Thanks,
    Trail

     
    Old 08-19-2007, 02:06 PM   #9
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    Re: Reclast approved by FDA

    I do not believe that dentists are over reacting. The drug companies are now putting warnings on their products. An attempt to avoid further suits??? It has also been reported lately that many cases of jaw death are just coming to light and that many in the past have not been reported nor was the link to the drugs made right away. I would also question any study. Who conducted the study and who funded it? How were these patients teeth before beginning the drugs? Many people have very strong teeth with little problems over the years, but for those like me who do not have a strong genetic history with teeth these drugs are so, so scary. Where would I be now facing my third extraction due to infection if dentists refused to treat me? Infection coursing through your body seems just as dangerous to me, if not more so, than osteoporosis. Every person must make their own decisions and those decisions must be respected. However, those decisions must be made with a great deal of thought and research. I am so glad that I said no to these drugs, not even realizing at the time what problems they could cause for me - it was just a gut instinct - and as I began to read and hear more and more with the relationship with teeth I was further convinced. Yes, my osteoporosis does worry me, but it worries me far more to not be able to deal with my dental health issues. And, I have had two broken bones from very hard falls (wrist and hand) in the past three years. Both of those bones healed within the normal time frame and very well. I have heard horror stories of bones not healing in women taking these drugs. Makes sense doesn't it. For a bone to heal, the body must make new bone to fill in and surround the break. How many people know that these drugs STOP the formation of new bone? Sadly today we can not rely soley on our doctors, dentists, and the drug companies to give us the answers. We must research on our own and make the right personal decisions.

    I am sorry for the rant, but having just been through a severe bout with kidney stones caused by calcium supplements which were encouraged for me by many doctors, and yes, the urologist said that was the cause, and now faced with many dental problems that could have gone untreated had I taken the drugs, I am very leary of what any one doctor or pharmacutical company has to say. I am taking risks with my osteoporosis. I know this. But, I am also getting my calcium from food rather than supplements (most specialists advise this), I am working out with weights, walking, staying active, and finding that my body continues to heal and be strong.

    Question all the time, and choose what sounds right and right for you. I wish I had listened to myself about the calcium supplements and understood that 1500mg did NOT mean 1500mg of calcium through supplements, but rather the combined daily total. No doctor, at any time, advised me on this nor explained it to me. Is that worth the pain of kidney stones and lithotripsy and then the passing of small pieces of stone. I think not. So even something seemingly so harmless and so encouraged by the medical community can cause havoc in the body and most certainly on the emotions. I was angry, upset, sad, depressed, and anxious that I had to endure such pain when all it would have taken was one doctor telling me the right way to go about things. These were all well meaning, educated, and respected people, yet..........

    glowing4

     
    Old 08-19-2007, 07:01 PM   #10
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    Re: Reclast approved by FDA

    Glowing: I have a question for your periondontist, would you mind asking him something for me?

    I read that some people can get osteonecrosis from having their wisdom teeth pulled. What I read was about a patient who didn't have osteoporosis, and had never taken any bisphosphonates but he still developed osteonecrosis from the "caving" that can occur after wisdom teeth are pulled. Evidentally some peoples jaw bones don't grow back after having wisdom teeth pulled causing a caving effect in the area where the wisdom teeth once where. He now has osteonecrosis, from this and having his wisdom teeth pulled many years ago. The only symptom he had was some type of trouble with the morals surrounding the wisdom teeth location. He had a cavitation scan and it showed ONJ. He's currently going through photon light therapy and something called a zappitator to stimulate bone growth. If I can find the article again, I'll post more info.

    I'll be keeping you in my thoughts with all your dental issues. I know how you feel about motrin, I've been taking those a lot, I just need to watch it because at some point if I take it too long it causes horrible stomach probs.

    TIA

    Last edited by DesertBloom; 08-19-2007 at 07:16 PM.

     
    Old 08-20-2007, 05:47 PM   #11
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    Re: Reclast approved by FDA

    Hi All: I don't know if you all have read about the "Dear Dr." letter that was sent out in 2004 by Novartis regarding Osteonecrosis of the Jaw, but I thought you might like to read it. According to this letter and another from an Oncology society, Novartis at least, has known about this disease since 2003. Novartis' main concern is cancer patients taking the stronger iv form of Zometa, but this problem applies to all the drugs in this class. If you read the Annals of Internal Med article, you'll see the actual figures in that case of iv use v oral use. Then there is the argument about cancer v osteoporosis and treatments of chemo, radiation, and corticosteroids. I hope I haven't bummed every one out, but at least the ray of hope is the small numbers of oral users with the disease. Unfortunately that doesn't help anyone dealing with it in that group of people, so for anyone that is dealing with this horrible disease, you're in my prayers.

    Here's the letter:

    [url]http://www.fda.gov/medwatch/SAFETY/2004/ZometaHCP.pdf[/url]

     
    Old 08-21-2007, 06:01 AM   #12
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    Re: Reclast approved by FDA

    DesertBloom, I am not seeing a periondontist, just my dentist, endodontist, and oral surgeon. I was going to ask my dentist yesterday your questions, but unfortunately I am in lots of pain and need two teeth extracted on Thursday. Right now I am in emergency dental mode, but once I get things settled down a bit I will talk to him and ask him your question. I also want to ask him how much he knows about all of this. Unfortunately, all of these specialists are so busy that they don't have lots of time to talk unless it is about your specific case, and I sometimes worry about taking up their time when others are waiting to get taken care of. My regular dentist, however, is a very good and nice man, so I will talk to him about it when I can.

    Hope you are not in too much pain and that you will soon find your answers. Ones mouth is more important than we often realize until things go wrong. It is difficult to have the simple pleasure of eating taken away or to have the lovely wind hurt your face where the pain is. I sincerely hope that your answers come soon.

    glowing4

     
    Old 08-21-2007, 03:38 PM   #13
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    Re: Reclast approved by FDA

    Glowing: Thanks for your input, and don't worry about asking any questions you have enough to handle yourself, I'll get it from someone

    Good luck I hope the pain isn't too bad and they can get the teeth done asap, without too much trouble.

    Take Care!!!

     
    Old 08-21-2007, 04:26 PM   #14
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    Re: Reclast approved by FDA

    Hi Osteo: I really don't know if denosumab is an anabolic, but I thought anabolics were meds that both stimulate osteoblasts and suppress osteoclasts. If that is the case then it isn't a anabolic in the true sense, but who knows I'll let you figure it out, or I'll do some more reading. Whether it's approved or not is another consideration. Since it's a drug that will be used for multiple medical probs, maybe it stands a better chance. Osteoporosis is only one of it's proposed applications (cancer, other bone diseases) so maybe someday it will make it to market.

    On the other subject, I don't know much about it. I do know that some pain mgte docs rx maronol (sp) which is the chemical form of the active ingredient in marijuana. I've never tried it, and I don't think that many insurance co's pay for it, but I'm not sure. My husbands oncologist at (UCLA) doesn't think much of the mj medicinal program, because he feels that smoking it is bad, because it can cause lung probs just like tabacco does, so he prefers the pill form for his chemo/radiation patients for the horrible nausea and also pain.

    I have NO idea how I'm dealing with this dental thing, last night I had one of the worst scares I think I've ever felt. I've had so many serious surgeries/problems where I didn't panic or get "too" scared and wondered why this problem was hitting me so hard. Even the osteo dx didn't hit me that hard, like almost everyone else. I have the ability to calm myself and forget about problems for at least some time, so maybe that's why, I really don't know. Since I've had so many bad dx's after a while it justs rolls off your back. But this tooth thing is different. I asked my husband about it, because basically he's that same as me, and able to put scary things "away" so to speak and not obsess over them. The ONJ problem is different, and the only thing I could come up with as to why it's hitting me harder than usually (actually cried for the first time in almost a decade) and I think it comes down to the fact that it is "so" physically disfiguring, and on your face no less, and there is NO treatment, or cure. There are some things that can be done to slow the process, but none of them are a solution/cure. My min met doc, reminded me, "you know there is no cure or treatment for ONJ-right?" and I said yes-like what else am I going to say??? I've read all I can on ONJ, and have seen all the "horrible" disgusting pictures.

    I still think I will be able to get my teeth pulled WITHOUT incidence. I don't know where that knowledge is coming from, but I'm holding on to it TIGHT.

    I saw the dentist today because I had an additional scare yesterday, which is probably why I got so upset, but what I thought could be something horrible, turned out to be a simple "cavity". So I told myself enough is enough I'm not going to panic anymore until I'm given something to "actually" panic over. The reason I was concerned is that I found 2 holes in two additional teeth and what looked like pus coming out. After seeing that and having a fever and pain in these teeth I immediately jumped to the worst possible conclusion. Anyway it turned out to be nothing major-2 small cavities-and yet I panic for the first time in a long time. So let this be a lesson to everyone, it's really stupid-sorry, but yes stupid to jump to "any" conclusion without any evidence!!!!! The evidence I had looked bad with white pusy fluid coming out of my tooth with my gum looking weird too, but it was nothing really, so I learned a Valuable lesson. There are always more than one explanation to what you might think is a major problem, and it could be that the problem is normal and minor, instead of major and life threatening.

    Hope you are feeling okay, have you been to the Eli Lily/Forteo site lately-the one you log into with your password? Well, they have changed it a bit and have included some new things in the side effects section that I never noticed before. You'll have to go check it out with your password-it's nothing major, but none the less interesting.

    About ONJ and extractions, is that 60% figure I gave you is 60% of a really small group, somewhere around 13 people, and the other 40% of 13 or so, contracted ONJ spontaneously. The point is that in the majority of the cases, extraction or dental surgeries precipitate this prob, and the balance of patients can get it spontaneously. I wish I knew the answer to your other question about why this occurs so much in the jaw, and at the moment I don't know. If I figure it out I'll let you know, but we all know that osteonecrosis can occur in any area of the body, and it reminded me of Bobby Kennedy's son's that had that, can't remember his name, I think that was the first time I heard of it, when his son was dx'd.

    Anyway that's enough for now you guys must get sick of my constant talking.

    It's not what happens to you...it's how you react to it.

    Last edited by DesertBloom; 08-21-2007 at 04:33 PM.

     
    Old 08-21-2007, 05:46 PM   #15
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    Re: Reclast approved by FDA

    DesertBloom-I am taking a long slow breath for you. You are a very strong and resilient person , of that there is no doubt. And, you employ your keen intellect to master the challenges that come your way. I think this ONJ(which is a problem you do not presently face) is throwing you off your balance because your mind cannot find the information that would help you to feel more confident. And, perhaps your doctors' covering their liability puts you into a frightened state. I don't understand your min met's comment-"you know there is no cure or trtmt for ONJ" what is she telling you? Are you supposed to either go ahead or not go ahead with extraction ? And, is not going ahead even an option?Is this just covering her liability? Are you going to proceed with the ctx? That would provide additional information , which you could have in your hands within the next week.

    I can understand how your fear must have gone into overdrive last night. Been there , done that. If there can be anything good from the night, it can be that you found some things that need dealing with and can be dealt with.Although, I know that you are left with your ONJ fears. Is there anyone in the literature that seems to be an expert in the area, that perhaps you could consult with?

    We do know for a fact that not everyone that has a tooth extraction and has prior bisphos. use gets ONJ. And again your time on Actonel was so brief - relative to probably many users length of use. And, perhaps your current use of forteo puts you in the best situation that you could be in to do the extraction, do you think that may be so?Again, maybe the ctx would help. Didn't you say your doc recently ordered a bsap and ntx- any results there?

    So the rx marinol(sp?) sounds to me that perhaps it could have some potential IF your insurance policy would cover it. I would think that with your seeking pain management and not finding something that helped that it would be covered. But, I don't know and all policies are different. Could you call your policy and find out if it is a covered med? I don't know why it would be treated differently than other covered pain relievers. It would seem worth a call. Yes, I can see what you are saying about how smoking would not be a good way to obtain the active ingredient and how the rx marinol could be a better solution. When you went to the pain specialists do they even lay this on the table as an option? You mentioned your husband's oncologist, you two are going through alot. It seems that before we leave this life as we know it, most everything gets taken from us . For some it seems harder , for some tooo hard!

    Another variant on your very wise closing comment is:

    You can't stop the waves, but you can learn to surf.

    From what I have seen , you seem to be a pretty good surfer.

    Last edited by osteoblast; 08-21-2007 at 05:57 PM.

     
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