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  • morphine in pump only FDA approved drug?

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    Old 12-11-2006, 05:36 PM   #1
    denicar
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    Question morphine in pump only FDA approved drug?

    We went to the PM dr today. my husband has had bloating ever since he had a morphine pump put in 2 years ago. Shoreline was kind enough to suggest trying other drugs in the pump since morphine can cause water retention and edema. the dr tells us that morphine is the only FDA approved drug that should go in the pump. Even though other doctors do use other drugs, he does not. it is a medtronics pump and he only fills it every 6 months or so. he is on a pretty high dose.

    Does anyone have any ideas how to research this? thanks!

     
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    Old 12-11-2006, 09:57 PM   #2
    aussie_jono
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    Re: morphine in pump only FDA approved drug?

    could your husband add a diuretic (Moduretic, Diazide etc) to his regime to control the bloating?

    even somthing otc with pamabrom in it would help

     
    Old 12-11-2006, 10:14 PM   #3
    Shoreline
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    Re: morphine in pump only FDA approved drug?

    Hi Deni, Your doc is correct about the FDA approval. However even medicare will cover other preservative free intrathecal meds. Dilaudid, Fentanyl and Sufentanyl are available. The risk of granulomas, "crystallization at the cath tip in the intrathecal space" is considerably reduced by the use of more soluble preservative free opiates. Morphine is the least soluble of them all.

    I'm not sure why there are so many catch 22's but the drug Prialt, "cone snail toxin" is FDA aproved aproved for IT use only. Most likely when medtronics first got their pump approved, they used the gold standard which is morphine. It worked. That's all they needed to get it on the market. It's expensive to run clinical trials and takes years on every drug that may be used. So Medtronics may just be passing the liability to the manufacturer to get aproved for IT use but the medtronics hasn't gone to the trouble of getting every possible med aproved for IT use where some meds have.

    If that's your docs policy, it's his policy. Just like some docs don't use opiates, BT mmeds or won't exceed X number of mgs. For whatever reason, he only feels comfy with medtronics short list of FDA approved meds. I would guess it limits liability by only using FDA approved meds even though it's known high concentration IT morphine can cause granulomas. We have a meber here that had their pump removed due to this.

    Just do an internet search for intrathecal hydropmorphone or IT fent and sufentanyl. They are commonly used and you see the proven benefit of having more than one choice in published abstracts that followed patients for years on other meds.

    If a docs not comfy going beyond X number of mgs or using meds commonly used for at least 15 years, the only answer is to find a new doc to manage the pump. It would likely be easier than changing a docs POV. He has an opinion, a right to attempt to reduce mal practice claims by sticking with only medtronics list of FDA approved drugs, but every doc has their own opinion.

    The pump is likely going to be in there for life, This doc isn't going to be around for life, at some point he will leave or retire.. Why not consult with a few other docs before you’re in the position of getting a 30 or 60 days notice in the mail that he's he's retiring or relocating. The more docs you know you can turn to, the better off you will be.

    Medtronics can supply you a list of medtronics approved implant and management docs in your area.That doesn't mean their aproval will limit the meds they will try, thay have just done the training and followow most of their guidelines. I've met the local MT rep and she had no problem with using dilaudid or any other preservative free med my doc uses. medtronics isn't the one taking that liability if a doc uses a non approved med and something catastrophic happens like a patient has a bad reactuon to the med. Every med carries that same risk? If you haven't taken it before, you don't know how you will repond or iff you are even allergic to it.

    Even if he has a pain contract with this doc, they can't prevent you from consulting or getting other opinions. Seeing another doc to ask if he thinks he's getting max benefit from the most advanced method of delivering opiates is worth getting a couple of opinions. IF they all say due to his injuries, his level of function may be as good ss it gets, but that's just a potential opinion. It's is well within his rights and doc #1 doesn't even have to know unless you choose to move on.

    Look for someone younger that's going to be around a while that's open to other meds and preventing granulomas which require opening the spinal cord to remove. The risk of paralysis Vs not wanting to be sued may be worth it in his mind, but it's not in mine. I was at a dose and concentration to be concerned about so I was moved to dilaudid. If he's using 25 or 30 mgs per ml, He is at risk, It has happened at lower concentrations but that's my docs cut off point. It doesn't make my doc better or smarter, he just has a different POV. He's not a soft touch but he's always been clear that 50% reduction in pain is what they shoot for. It does takes large doses to reach that, but I’m more functional than I have been at 600 mgs of oral morphine per day.

    The goal would be to get to the point that he can be more active, Yes he will have pain, but they can find a medium if his expectations are reasonable.
    Take care, Dave

    PS... Please anyone else chime in. I certainly don't know it all or want the last word. If I had all the answers I wouldn't be here looking for something myself. I'm sorry if some people are worried about contradicting me or feel an opinion other than mine might be seen as lesss valuable. We have some grerat folks here that can definitely make their point better than I. It's easiest enough to say it's great that worked for Dave but didn' work or help me or my doc says this or that. PM is so much about the docs comfort level and opinion. You can't argue that opinion, it won't change it. There is no way to see a doc without having his opinion effect the way he treats you. Is he right? who knows? Especially when every doc and everyone has their own POV.

    Last edited by Shoreline; 12-11-2006 at 10:35 PM.

     
    Old 12-12-2006, 05:38 PM   #4
    geifer
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    Re: morphine in pump only FDA approved drug?

    Shoreline It's geifer I will jump in here.You said they checked your husbands heart have they checked him for lymphedema? It is abnormal swelling in certain parts of the body. The lymphatic fluid collects in the soft tissue. A friend of mine has this and I thought that it could be checked into. I am on my thirded pump and never had any swelling problems. I hope this helps take care and stay safe geifer

     
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