NeuroTalk Support Groups - What is the truth with the FDA?

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What is the truth with the FDA?

What is the FDA really going to do? Are they going to be taking certain pain med's off the market or is it the acetaminophen out of these med's?

Is there a med that is hydrocodone only? I was told by my doctor that this is not going to be marketed for another few months.

Why are they doing this now after all these years?

Good points!

As to stand-alone availability, your information appears to be correct. According to MedlinePlus:

Hydrocodone is available only in combination with other ingredients, and different combination products are prescribed for different uses. Some hydrocodone products are used to relieve moderate to severe pain. Other hydrocodone products are used to relieve cough. Hydrocodone is in a class of medications called opiate (narcotic) analgesics and in a class of medications called antitussives. Hydrocodone relieves pain by changing the way the brain and nervous system respond to pain. Hydrocodone relieves cough by decreasing activity in the part of the brain that causes coughing.

http://www.nlm.nih.gov/medlineplus/d...s/a601006.html

That said, of the approximately 60 combo products that are listed as currently available, one in particular looks like it might fit the bill on a short term basis for people with pain issues who don't need anything stronger: Vicoprofen® (containing Hydrocodone and Ibuprofen) where each tablet only contains 200 mg. of Ibuprofen, basically a single Advil. And even though both products are labelled to the effect that they shouldn't be used for more than 10 days, I know that all of my doctors have seen my list of drugs showing that I take 3 Advil at night, and no one has ever said a word.

And as to why now, I suspect that goes under the heading of "after-marketing reporting." It's sort of like when a friend of mine was being shown around a sub in San Diego and asked why there were all those safety features, to which a naval officer replied "Each one was paid for in blood."

Mike

I think it is hard to say. We will see about 6months pass as the
recommendation is considered. Some think it will be accepted.

I wonder what will happen to those people who use Vicodin or Tylenol with Codeine, for short term purposes following dental procedures or surgery. There are far more people doing THAT than using for chronic pain! If doctors get up in arms about this move by the FDA, enough, it may stall for this reason alone.

Vicodin has been the top diverted drug for many years on the black market. I think this move is to get it away from that venue.
If the FDA really wanted to control acetaminophen as they claim, then OTC Cold products would not have been exempted from the ban like they were.

I do think acetaminophen 500mg will be removed from OTC status. That would leave 325mg tablets only. And the children's versions will most likely be changed as well.

Vicoprofen has never been a big seller. Some orthopedic doctors use it but even then it is not popular. Chronic use of NSAIDs brings risk of GI bleeds, and heart attacks. The heart effects are rather new, but still doctors don't like to use NSAIDs chronically in some patients with cardiac complications.
The bleeding is also big...a silent bleed can occur with no warning. My neighbor had one a few years ago on Naprosyn and almost died. The doctors had to tie off an artery in her duodenum because they could not stop her bleeding. She had no warning. The numbers are staggering for this family of drugs for pain/inflammation:
http://www.mypharmacydata.com/arthri...-and-downsides

Quote:

“If deaths from gastrointestinal toxic effects of NSAIDs were tabulated separately in the National Vital Statistics reports, these effects would constitute the 15th most common cause of death in the United States. Yet these toxic effects remain largely a ’silent epidemic,’ with many physicians and most patients unaware of the magnitude of the problem. 70 Furthermore, the mortality statistics do not include deaths ascribed to the use of over-the-counter NSAIDs “7l
—Michael M. Wolfe et al., The New England Journal of Medicine, 1999

The moves by the FDA are paralleling the work being done in the Legislature now. It is hard to say if hydrocodone and other acetaminophen combo opiates will be taken off the market or only more strictly controlled...say RX for short term use only, smaller quantities allowed per fill, for emergency use.

A group of Drs. met in New York and they are suggesting that Vicoden and Perocet both be discontinued. They say that the FDA usually follows these Drs. suggestions.

So many people are on these two meds so it will be interesting to see.

Ada

Quote:

Originally Posted by mrsD (Post 533942)

Point taken. I guess the dark humor in this is that it's my understanding that few CRPS patients are on Hydrocodone for too long before it stops working and they are moved onto harder sauces. (At least that's how it worked out for me.)

Mike

I have been on many different med's in the past and I do not tolerate many of them. I have to avoid N'saids due to other health conditions, so I'm really stuck if the FDA does do this.

Thanks for replying.