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FDA changes
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There is a lot of confusion and misinformation out there regarding the changes the FDA is making regarding narcotics. The news release clearly says that they are removing high concentrate morphone sulfate oral solutions, and immediate release tablets containing morphine sulfate, hydromorphone or oxycodone. This action does not include oxycodone capsules.
The companies that make these drugs were warned way back in 2006 that they needed to stop manufacturing 14 unapproved narcotic drugs. The FDA is cracking down on marketing of unapproved drugs in an effort to protect the public from drugs that are not proven safe and/or are not the proper dosages as labeled. Their exact words were: "It is a high priority for the FDA to remove these products from the market because they may be unsafe, ineffective, inappropriately labeled, or of poor quality. If the drugs companies will prove that the drugs meet the FDA's safety and effectiveness standards, then they can reapply for approval and put these drugs back on the shelves. The drugs companies don't want to go through this process because it is very expensive. To view warning letters, the names of the companies and their affected products go here: (unapproved drugs) http://www.fda.gov/cder/drug/unapp...#narcotics A complete list of unapproved drugs is at: http://www.fda.gov/cder/drug/unapp... And if you want to see if your particular version of narcotic is available go here: http://www.accessdata.fda.gov/scri... I hope this helps clear things up and allows you to find what drugs you can replace your removed products with. If you have questions, I am pretty familiar with the action and its details, so please don't hesitate to ask me. I will do my best to help everyone try to understand this confusing info. Hugs, Fern Posted on 07/01/09, 07:07 pm |
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Okay... so they are banning vicodin and percocet morphine sulfate, hydromorphone and oxycodone.... what will be left? I am really worried about this now- I thought we were only needing to worry about Vicodin and now all this...there will be nothing left???? Or ...there will be a shortage of whatever will be left.... that docs can prescribe their patients... how long of a warning will we have before they are all gone?? please reply! 
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No, not exactly! You need to read the letters and the info. to see exactly what is going on. It affects certain pharmaceutical companies is not all of them.
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Thank you for your input.
I have searched the internet AND went to the FDA site and cant find anything about it... It talks about Vicodin- but nothing about WHEN they will cut everyone off and how it will all work. I am very upset and confused.
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The warnings were sent out in 2006 and the FDA is just now taking these drugs off the market. The drugs were removed in June. Its just the drugs on the list and not all of them. Your pharmacy should be able to tell you if the version you usually get is available or not, but it would be helpful for you to read the links I sent. If not, then you should ask your pharmacy. The problem with that though is that not all the pharmacists are up-to-date or have correct info on this. If you want to pm me and tell me what drug you take, I will be glad to look it up for you. I will need the info off your bottle. I need the name of the drug and whether or not its generic. I will need the pharmaceutical company that its obtained from, which is usually on your bottle. If not, call your pharmacy and ask them what company this drug is coming from. Then I can look it up for you.
But rest assured, its not *all* drugs. Its the ones that don't have approval. I take Dilaudid and many of the generic forms of this drug have been removed from the shelves, but some generics and almost all name brands are still available.
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I called my pharmacist and they have no clue about any of this... urrggg I am so confused... :(
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As far as I know you wont be able to get percocet or vicodin which contain Tylenol. You will still be able to be prescribed narcotic medication though. Roxycodone is oxycodone with no tylenol (acetominophen) as I understand it and you can ask for that. My understanding is that the Tylenol is causing liver damage in the meds, not so much the narcotics causing damage.
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Correct, is the Acetaminophen that causes liver damage, not the Oxycodone. This has been well known by the medical community and the general public for years, but now finally the FDA has decided to do something about it. So for those of us that take Vicodin or Percocet, your Doctor's most likey will switch you to Roxycodone or Oxycodone IR or Percocet without Acetaminophen, so no worries my friends, there is always something that can be done!
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I am afraid that again misinformation is being passed around. All forms of Percocet have NOT been removed from the market. The FDA assigns numbers to each drug approved and nonapproved based on their strength and who manufactures them. So Percocet made by say two different companies will each have their own number. Percocet #085106 made by Endo pharm has been removed. However, Percocet #40330, #40331, and #40334 made by Endo pharm are all still available. They all contain Tylenol so its not that the ones with Tylenol are being removed. Its the ones who have not done the proper testing and the ones that have not been properly approved by the FDA due to the testing not being done.
I looked up Vicodin as well and found the same thing to be true. Vicodine #085667 has been removed. Vicodin #088058 is still being sold. Vicodin ES is still available. Vicodin HP is also still available. Again, this has nothing to do with whether or not a drug contains tylenol or any other additive. It has to do with the drug companies obtaining proper approval particularly for generic forms of the drugs.
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I spoke with my physician as well, and he said the same thing. I am in the process of changing physicians, so this should be interesting!
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