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Old 04-01-2009, 10:36 PM   #1
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Thumbs down Big Problems Coming from FDA/DEA for CP Patients

I hate to be the bearer of bad news, but yesterday, the FDA announced that it has waged war on many manufacturers of narcotic meds. I can't post a link, which is a shame, because this is major news and could adversely effect a great deal of us.

Long story short, the FDA has announced that many manufacturers must cease producing and selling "unapproved" versions of meds. Even though many of the meds on the list have been sold legally for years, some even for decades, they never went through an FDA approval process (weren't required to at the time) therefore they cannot be sold now. And, the FDA isn't grandfathering them in.

The makers of the attached meds must stop producing within 60 days. In the FDA press release, they bragged about confiscating $24million worth of "unapproved" meds from a major manufacturer as a "warning" to others...Has to be Ethex given the DEA and FDA have shut them down.

Here is a list of those affected:

Mallinckrodt Inc. Pharmaceuticals Group
Morphine Sulfate Concentrate
Oral Solution 20mg/ml

Boehringer Ingelheim Roxane Inc.
Roxanol Oral Solution, 20 mg/ml;
Roxicodone Tablets, 5 mg

Roxane Laboratories, Inc.
Hydromorphone Hydrochloride Tablets, 2 mg & 4 mg

Glenmark Generics Inc.
Morphine Sulfate Tablets, 15 mg & 30 mg;
Morphine Sulfate Solution Immediate Release Concentrate, 20 mg/ml;
Morphine Sulfate Solution Immediate Release Oral Solution, 20mg/5ml

Lannett Company, Inc.
Morphine Sulfate Solution Immediate Release 20mg/ml;
Hydromorphone HCl Tablets, 2mg and 4mg

Lehigh Valley Technologies Inc.
Morphine Sulfate Tablets, 15 mg & 30 mg;
Morphine Sulfate Solution Concentrate, 20 mg/ml

Physicians Total Care, Inc.
Morphine Sulfate Immediate Release Tablets, 30 mg;
Hydromorphone Tablets, 2 mg;
Hydromorphone Hydrochloride Tablets 4 mg

Xanodyne Pharmaceuticals Inc.
Roxanol Oral Solution, 20 mg/ml;
Roxicodone Tablets, 5 mg

Cody Laboratories, Inc.
Morphine Sulfate Solution Immediate Release
20mg/ml

Do a search and I'm sure you'll find all the info you need.

Regards,

Ex

 
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Old 04-01-2009, 11:06 PM   #2
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Re: Big Problems Coming from FDA/DEA for CP Patients

brilliant post, this should be bumped up. I would imagine that anyone reading this would want to get to their doctors asap - the shortage of oxycodone and fentanyl will only get worse.

Australia hasn't been affected so far - we get most of our oxycodone from the UK. Morphine though, I believe we get from the USA - many of our older products haven't been through our TGA approval process and the TGA usually follows the FDA. It will be interesting to see what happens.

Is there anyone here on morphine sulfate that will be affected? I imagine that many of these are generic brands - what will happen with insurance companies?

Great post, Ex, I'll have a look (and call mundipharma) to find out if anything is happening here.

 
Old 04-01-2009, 11:59 PM   #3
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Re: Big Problems Coming from FDA/DEA for CP Patients

I went to my doctor today and got my normal monthly prescription for morphine sulfate 15mg IR. My normal pharmacy did not have any in stock. I called over TWENTY different pharmacies before I found a little mom & pop pharmacy that could fill my script. This was exceedingly stressful on me. I was at the point where I was going to call my doctor to prescribe something different. I have been having difficulties filling this and my long acting MS Contin..but have usually been able to get them filled at the second or third pharmacy. This is really getting frightening for me...
I have had a terrible time finding a Long acting pain medicine that I could tolerate (went through Opana and Oxycontin with terrible reactions). I have finally stabilized on the Morphine sulfate and now face not being able to get the medicine.....

Lou

 
Old 04-02-2009, 04:01 AM   #4
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Re: Big Problems Coming from FDA/DEA for CP Patients

Thanks for the heads up. I'm printing the list and it's going with me to the doc tomorrow. My main reason for going is that the "do they have it, do they not" is putting too much stress on me. Hopefully we can find something where I won't have problems, but this list makes it much less likely.

If this involved say blood pressure or heart medications you can be sure that the media would be screaming their fool heads off. Since the majority of them have a definite "attitude" about CP paitients we're going to have to make our own noise. I would encourage everyone in the US to contact their senators and congressional representatives, I will be doing so this morning. I would suggest that those outside the US contact whatever national representatives they have, sorry I don't know the specifics outside the US.

Unfortunately I would guess that this will only get worse for those of us in the US over the next few years.

Tigg.

 
Old 04-02-2009, 09:14 AM   #5
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Re: Big Problems Coming from FDA/DEA for CP Patients

why in the %^%$#* aren't the fine folks at the DEA doing their REAL jobs like keeping out of our country all the actual ILLEGAL meds and getting the REAL bad guys. god ex, this is just sooo incredibly sick. from what i know of the actual manus of the class IIs that i take right now, they are listed right there as the 'back ups" the 24 hour pharm actually has in place too when the ethex nightmare hit. this is just pathetic. just what in gods name is going to happen to US,the people who REALLY suffer from this type of BS. i feel sick. thanks for the info ex. the sooner we know this stuff the better prepared we can all be. dam. Marcia
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Old 04-02-2009, 10:42 AM   #6
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Re: Big Problems Coming from FDA/DEA for CP Patients

OMG! Like we need more problems. Ugh. The only good thing is that I was recently accepted into the Purdue program so I am getting the name brand oxycontin for 1/4 of what I was paying for the generic. So, I haven't had to worry about the shortage or the cost recently.

It's bad enough that I am now out of work because of CP, but now this?! Things are really getting rediculous here.

 
Old 04-02-2009, 01:19 PM   #7
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Re: Big Problems Coming from FDA/DEA for CP Patients

I am on MS Contin which is extended release Morphine Sulfate

 
Old 04-02-2009, 02:11 PM   #8
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Re: Big Problems Coming from FDA/DEA for CP Patients

Ex
If it's not too much trouble would you PM me where to look for this info?
thanks

FOUND IT-Never mind!!!

Last edited by eyesworld; 04-02-2009 at 02:29 PM.

 
Old 04-02-2009, 04:51 PM   #9
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Re: Big Problems Coming from FDA/DEA for CP Patients

i read this when it hit the media. the article said that the fda said there will be no shortages as a result of this. how can they say that? even though none of my meds are on the list, if those patients who take the newly banned drugs can't get those, they will have to get other meds, which will affect how much of the non-banned drugs are available. unless the government allows the pharm companies to produce more of the non-banned drugs, i can't imagine how there won't be a shortage. i'm scared too. i don't know what i would do.

 
Old 04-02-2009, 05:22 PM   #10
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Re: Big Problems Coming from FDA/DEA for CP Patients

I took a look at the FDA site and read the article. How can a drug not be approved by the FDA and still be sold??? I don't understand that at all. Maybe someone can explain that one to me. why is it only certain companies and certain dosages? I am sure the pharmaceutical companies are about ready to blow a lid on this as well. Do you know how much money they will lose by not being able to sell those.

Now from what I understand the Brand names of morphine, hydromorphone will still be sold or other generics that are not on that list. It is very confusing and they did not really do a good job explaining it on their site either.

brian

p.s I thought that I would post the list of morphine, hydromorphone, and oxycodone pills that will still be on the APPROVED LIST
Morphine
Morphine Sulfate Tablets 15 & 30 mg Roxane
Morphine Sulfate Oral Solutions10mg/5 ml & 20mg/5ml - Roxane
Morphine Sulfate Extended Release Tablets - Mallinckrodt
Morphine Sulfate Tablets Extended Release Endo/Skyepharma

Hydromorphone Immediate Release Tablets
Hydromorphone immediate release tablets – 2, 4, AND 8 mg -Mallinckrodt

Oxycodone
Oxycodone immediate release tablets – 5, 10, 15, and 30 mg Mallinckrodt
Oxycodone immediate release tablets, 5, 15, and 30 mg - Vintage
Oxycodone Extended Release Tablets, 10 mg - Purdue
Endo
Oxycodone Extended Release Tablets, 15 mg - Purdue
Oxycodone Extended Release Tablets, 20 and 40 mg - Purdue

Last edited by brianpain33; 04-02-2009 at 05:34 PM.

 
Old 04-02-2009, 06:58 PM   #11
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Re: Big Problems Coming from FDA/DEA for CP Patients

Quote:
Originally Posted by brianpain33 View Post
I thought that I would post the list of morphine, hydromorphone, and oxycodone pills that will still be on the APPROVED LIST
There are far more meds than this on the approved list, for example, all the patches & many other Oxycodone formulations. All they did was further confuse people by publishing that list.

I think the best way to look at this situation is to look at the unapproved list, and if you take any meds on that list, then talk to your Dr. For example, "morphine sulfate" by some companies are on the list, but the exact same med, "morphine sulfate" is made by several other companies and "approved."

What's most interesting, is that in at least one case, a manufacturer has one med on the unapproved list, but not others (in the same class). For example, the maker of the brand "Roxicodone", Xandoyne, has it's 5mg Roxicodone Oxy IR on the list, but it's 15mg and 30mg Roxicodone tabs are not on the list. If the much more potent versions were "approved", shouldn't the weakest formula be??? Go figure.


Quote:
Originally Posted by Toonces1 View Post

The article said that the fda said there will be no shortages as a result of this. how can they say that? even though none of my meds are on the list, if those patients who take the newly banned drugs can't get those, they will have to get other meds, which will affect how much of the non-banned drugs are available.
I couldn't agree more! The Director of Compliance at the FDA, Deborah Autor, was quoted in the press release as saying "while some patients are taking the unapproved narcotics, there are plenty of approved brands of the same medications. She promised there will be no shortage of meds in the market." How can she make "promises"????

Not only will patients need to move to other meds in the same class (for example from one morphine sulfate to another by a different company), but many Docs will move their patients to different meds altogether, thus, creating a shortage with those meds. As we all know, there's already a shortage of Oxy IR, and this can't do anything but further hurt that situation, especially since some Oxycodone formulations are on the list.

When I spoke with my pharmacist about this today, the first thing out of his mouth was "How much you wanna bet that a bunch a people will be put on Oxycontin now...Won't that just be great"?


Quote:
Originally Posted by feelbad View Post

why in the %^%$#* aren't the fine folks at the DEA doing their REAL jobs like keeping out of our country all the actual ILLEGAL meds and getting the REAL bad guys.
Great point! If some of these meds have been on the market for several decades, how is the FDA just now getting around to declaring them "unapproved"? Instead of dropping the hammer on these companies and causing major market disruptions, how about working with them....Giving them a certain reasonable time period to get the drugs certified / approved. This about the last thing the FDA needs to be spending time with, especially with a current Oxy IR shortage.

I also find in incredibly ironic that all of this is going on at the exact same time that the Nat'l Pain Act is weaving it's way through Congress. It was just approved by the House, and is not headed to the Senate, for their approval. One of the main parts of the bill is to increase the access Americans have to quality pain mgt. How is FDA action helping things????

Regards,

Ex

 
Old 04-02-2009, 08:06 PM   #12
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Re: Big Problems Coming from FDA/DEA for CP Patients

Hey ~ All ....
I don't wanna throw a Dog Leg Left in here...
Could there be a possiblity that FDA is working all this due to the major increase in wanting to open Drug Co. in China ??????? and the USA consumer knows the toxic issues that come out of China have been death defying.

Be patient with me... Brain Fog is thick.. I'm gonna probably have to re-read this thread a few times over... and shreak for what I wrote... BUT.......
had to share as soon as I could or I'd forget my point.. Brain Fog is like that..

Just so all knows I am beside myself for the torment this is causing for all us !

 
Old 04-02-2009, 10:16 PM   #13
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Re: Big Problems Coming from FDA/DEA for CP Patients

How the FDA can possibly find justification for what they are doing, and the speed that they are doing it, is beyond me.
There is so much evidence to show just how difficult it is to find the right medication at the right dose WITHOUT dangerous side effects for each patient. There is also the issue of fillers, a little known but very real risk to patients. Almost everyone is allergic or sensitive to something - the fillers that are used in drugs are some of the most common allergans around. Lactose, talc...the list goes on.
Then comes why would they do it so quickly - some patients are unlikely to even get into a pm in time for the change, let alone trial various medications to find what SAFELY works for them. Unbelievable. Surely this is a breach of your human rights act?
The reason why these drugs were not approved and there are other doses that will still be available is because the 'unapproved' versions didn't go through the process of approval because of the laws at that time. It is only recently that all doses (whether they be lower or higher) had to be approved. This is a very expensive process for drug companies.

I have been in contact with Mundipharma (the company that does most of our narcotics, expect fentanyl and a couple of other minor companies) and all products have been through the TGA approval process. That said, it is predicted that the US will NOT be able to provide medications for ALL patients as they say because of limits on production amounts that take time to be lifted. It is likely that there will be a global trickle down effect.

This is very disappointing, I am very sorry for all of you under stress because you take morphine sulfate. I am also concerned for those taking oxycodone (even if you live in Australia, like me!) because this is a very highly regulated product and increased manufacture is going to take time to happen. We get our oxy from the UK but our law, your law and the UKs law all state that swapping a patient to a higher dose narcotic of a different compound is unacceptable because of the risks of addiction etc. We all know that this isn't the case but we're used to the ignorance of others.

What will doctors do when they are informed by the government that they are not to swap patients to oxycodone or fentanyl simply because of a shortage? I don't know if that's what will happen there, but it's what will happen here. Lawsuits perhaps? Almost certainly care will deteriorate for patients that are already in a very stressful situation.

Good luck all.

 
Old 04-03-2009, 04:58 AM   #14
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Re: Big Problems Coming from FDA/DEA for CP Patients

Juliet,

There has been a huge change in government control of all types of business in the US since Jan 20 of 2009. Seriously, a year ago, if someone had told you that the government would fire the CEO of GM would you have believed it? This change really isn't even getting any media attention, probably because most of the media in the US has a huge bias against anyone who requires pain medication. If this had been a blood pressure or heart medication there would be national outrage on the part of the media.

For the FDA to say that there won't be any shortages is ridiculous due to the manufacturing restrictions that they have in place. This move is going to cause a lot of people to not be able to get their medication.

There isn't really any right to treatment of pain in the US unless you happen to be in jail or in prison where refusal to treat pain would be considered to be torture or cruel and inhuman punishment. Hopefully HR756 that Executor posted about will start to change that, if it gets past the Senate.

Tigg.

 
Old 04-03-2009, 08:27 AM   #15
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Re: Big Problems Coming from FDA/DEA for CP Patients

just one little tidbit of info that i did happen to run across(cannot remember where exactly) but any given drug co has a VERY strict and set 'limit' on the quantity of any given med they can actually manu like in a certain time period, then, by law, they have to stop production. that really helps us sooo flippin much doesn't it? sick sick sick is all i can say. later it will be owe owe owe i am sure. sick, Marcia
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