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Executor
04-01-2009, 10:36 PM
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

Jema X
04-01-2009, 11:06 PM
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.

Lou1
04-01-2009, 11:59 PM
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

tiggertoo2174
04-02-2009, 04:01 AM
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.

feelbad
04-02-2009, 09:14 AM
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

jma295psu
04-02-2009, 10:42 AM
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.

lifeaftr40
04-02-2009, 01:19 PM
I am on MS Contin which is extended release Morphine Sulfate

eyesworld
04-02-2009, 02:11 PM
Ex
If it's not too much trouble would you PM me where to look for this info?
thanks

FOUND IT-Never mind!!!

Toonces1
04-02-2009, 04:51 PM
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.

brianpain33
04-02-2009, 05:22 PM
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

Executor
04-02-2009, 06:58 PM
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.




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"?




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

Drain Bamaged
04-02-2009, 08:06 PM
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 !

Jema X
04-02-2009, 10:16 PM
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.

tiggertoo2174
04-03-2009, 04:58 AM
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.

feelbad
04-03-2009, 08:27 AM
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

brianpain33
04-03-2009, 01:03 PM
I just wanted to note that the Approved list that I posted was ONLY FOR MORPHINE, HYDROMORPHONE, AND OXYCODONE products. All other medications such as HYDROCODONE, FENTANYL, DEMEROL, ULTRAM, ETC. will not be on the unapproved list at least not yet.

brian
p.s. I did not see anything on the list about the Oxycontin 80mg or the 160mg. do they even still make these strengths? If so then why did they not list these?

Executor
04-03-2009, 06:54 PM
I did not see anything on the list about the Oxycontin 80mg or the 160mg. do they even still make these strengths? If so then why did they not list these?

Purdue Pharma does distribute the 160mg in the U.S. anymore. They do distribute the 80mg, however. As to why it wasn't on the list, I can't answer.


To be honest, this whole thing is beyond confusing. I've got some real issues that no one seems to be able to answer:

(1) If some of these meds have been on the market for several decades, why has the FDA just now gotten around to declaring them "unapproved"?

(2) Given the length of time many of these meds have been on the market, why didn't the FDA work with these manufacturers and give them a reasonable amt of time to get the meds "approved", rather than abruptly insisting they be removed from the supply chain?

(3) According to the press release by the FDA, the department's Chief Compliance Officer said that one of the meds on the list of unapproved meds accounts for over half of the sales market for that med category. So, how can this FDA officer "promise" there won't be shortages? Any person with half a brain can figure out that if you eliminate a product that accts for over half the sales market, supply and demand issues surely will follow. For example, if you have six dairy farms that produce milk, and one of them supplies over half the milk for a given market, and is abruptly shut down......Isn't it feasible to think there will be significant milk shortages, at least in the short run? Even if the remaining five farms increase production, they don't have the appropriate supply chain dynamics set up to handle the change in market position.

(4) The timing of all of this is very suspicious to me. It's no secret that there are major problems in the controlled med market right now with the Oxy shortage. Given that some of these meds have been on the market for decades, why did the FDA choose the current time frame to crack the whip? Couldn't they have at least waited until we pulled out of this Oxy issue? The conspiracy theory part of me says it was done on purpose as an all out assault on pain management.

The ultimate irony of all this is that at the very same time all this is happening, the Nat'l Pain Act is weaving it's way through Congress....Just approved by the House, and is now in the Senate.

According to the bill summary, "People in pain often face significant barriers that can prevent proper assessment, diagnosis, treatment and management of their pain. The National Pain Care Policy Act of 2009 is designed to address many of these barriers by improving pain care research, education, training, access, outreach and care."

Personally, I see a big conflict between recent FDA actions and the basic premise of the Nat'l Pain Care Policy Act.

Sorry for the rant, but these recent actions have me very worried.

Regards,

Ex

Jema X
04-03-2009, 09:28 PM
Ex,

I think that your fears are fair and reasonable. Anyone, including myself would become a bit paranoid about this sort of thing happening and the timing.

I've been doing a bit of research because Australia follows the US laws so closely on medications and have found some pretty disturbing stuff - most of it covered by EX.

The only thing that wasn't covered is the companies such as purdue and others unaffected (or still in production of the mentioned products) haven't been given permission as yet to produce more product each month!!! What the??? How can the FDA give any promises unless they're planning to import which will severely affect countries such as the UK and Australia.

Also, (and I'm an O fan in many ways, to be honest) the government doesn't seem to be very concerned about pain management and drug management etc. They are concentrating on legal cp patients rather than illegal drug dealers, I don't understand this?

The main production company here and my gp both think that this is a violation of human rights (if there is a shortage) and that if they do have to import because they can't supply (and the government finally realises that cp patients need meds) there will be a world wide shortage. It all seems massively irresponsible to start something like this without a longer time frame, a plan of attack (getting 'approved' companies to increase supply a few months before the decision is announced) and without taking account of the current bill going through the senate.

Insane.

Executor
04-04-2009, 06:58 AM
Thanks for the follow up Juliet. You make some great points......



I've been doing a bit of research because Australia follows the US laws so closely on medications and have found some pretty disturbing stuff - most of it covered by EX.

The only thing that wasn't covered is the companies such as purdue and others unaffected (or still in production of the mentioned products) haven't been given permission as yet to produce more product each month!!! What the??? How can the FDA give any promises unless they're planning to import which will severely affect countries such as the UK and Australia.

Great point. I suspected from the beginning that the "promise" was as empty as it gets....Nothing more than lip service, quite frankly.


They are concentrating on legal cp patients rather than illegal drug dealers, I don't understand this?

I couldn't agree more. There are FAR more important things to be worrying about. I also find it incredibly ironic that our current Attorney General here in the U.S., Eric Holder, recently announced that the Feds would no longer be doing raids on medical clubs selling Schedule I meds in California (and other states), yet they are shutting down these perfectly legal manufacturers, who have been marketing some of these meds for decades.


The main production company here and my gp both think that this is a violation of human rights (if there is a shortage) and that if they do have to import because they can't supply (and the government finally realises that cp patients need meds) there will be a world wide shortage. It all seems massively irresponsible to start something like this without a longer time frame, a plan of attack (getting 'approved' companies to increase supply a few months before the decision is announced) and without taking account of the current bill going through the senate.

Again, I couldn't agree more. I spoke to my pharmacist at length about all of this and he said what's going to happen is that we're gonna see a huge swing towards Oxycontin and methadone...Will almost have to, because nothing else will be able to handle the demand.

I'm so upset by all of this that my head is spinning. CP people suffer enough! I'd like to call that Chief Compliance person, Deborah Autor, at the FDA, and have her come live with me for a day....I think she'd change her mind on things.:rolleyes:

Regards,

Ex

tiggertoo2174
04-04-2009, 03:47 PM
I saw my doc yesterday, I went to get my scripts and also to have her check an allergy problem. I took a printed copy of the information from the FDA website. She is NOT happy, and sees no reason whatsoever to be pulling medications off the market that have been available for decades. My internist takes care of my meds since that seems to be the way they work it in this area, and she has a lot of elderly paitients who are going to be having problems with this. We were able to work out something that will likely work for me, but some of those paitients may not be able to switch as easily as I can. I consider myself to be very fortunate to have this Dr.

Juliet, I think one of the reasons they choose to go after legitimate CP paitients is that we are a much easier target. They know where we live and it's much easier to go after us than to bust a meth lab even though they know very well where those are too. At least around here it looks as good on the news to say they are cracking down on "illegal" drugs by having the FDA pulling these meds, they way the news media plays it you would think CP paitients are dying in the streets by the hundreds from oxycodone overdoses rather than leading perfectly normal productive lives. Unless one of us has to use a cane or something most of them wouldn't be able to pick one of us out of a crowd at the grocery store. Personally I would prefer the government to stay the heck out of my life as much as possible. I don't want or need the govt to take care of me. I know that somebody has to take care essential infrastructure like highways, airports and the like, but I would prefer them to stay the heck out of my life and my bank account.

Tigg.

jma295psu
04-04-2009, 04:15 PM
Nicely said both Tigger and Ex! I wonder what will happen when the Nat'l Pain Act gets passed...

Jean

Executor
04-04-2009, 06:53 PM
What's also amazing is that the FDA/DEA obviously didn't give Docs any type of a "heads up." All this news just hit and we patients are apparently educating the Docs when we take our print outs in to them at our appointments. Talk about an upside down system!! This whole thing is a nightmare.......

Regards,

Ex

jma295psu
04-04-2009, 09:07 PM
Ex,

I didn't even think about doing that! My PM doc is the best in the area, so he sees a lot of people. I will definitely give him a heads up. I don't like this at all!! Thank you very much for posting it, though. It will affect all of us in the end.

Jean

Jema X
04-05-2009, 01:01 AM
Nicely said Tigg.

If this happened to me, I'd go to the media - with others that I can find or by myself it I had to. There are television shows such as A Current Affair or Today Tonight that would very likely show this sort of stuff. I have a terrible fear of people knowing my personal business but my meds are like an (unfortunate) addition to myself. If stopped my life wouldn't be worth living.

Going to the media might not change things for everyone but I bet I'd be getting my script changes approved. It sucks but it's true.

Here we can also contact our drug companies and local government (this what I'd probably do first actually) and try and get changes seen to. I talk reasonable to my local member of parliament and if nothing was happening, I'd explain that I would have to proceed to the media because I was in so much pain and I couldn't live my life. Perhaps it would do the government good for joe public to actually see what a difference cp makes to our lives...because of the fact that many of us have canes or other signs of our disabillity.

I hope no one feels offended by this post. I'm a pretty passionate person and I tend to get very upset about issues that I believe breach our basic human rights. We get little treatment and research grants as it is. It's unacceptable.

tiggertoo2174
04-05-2009, 08:24 AM
Juliet,

Good point about contacting the drug companies, I hadn't thought of that. In the US probably the congress person and senators for the state would be the appropriate contacts, but I think I'll contact my state reps too.

Tigg.

Executor
04-05-2009, 10:26 PM
In the US probably the congress person and senators for the state would be the appropriate contacts, but I think I'll contact my state reps too.


This is probably the best thing we can all do @ this point. Unfortunately, the drug companies are @ the mercy of the FDA / DEA, so they have little to no power in this one.

We need congressional or presidential intervention. After all, the FDA head reports to Obama. He could fix it himself.

Regards,

Ex