FDA issues warning on naproxen [Aleve, Naprosyn] painkiller

MSNBC ^ | 6:39 p.m. ET Dec. 20, 2004 | Reuters

[AnimalLover]

I've been on it for over 2 years, and celebrex before that. I guess I am screwed. I guess you have to die of something!

Looks like I'm in trouble too. Started with Vioxx, then to Celebrex and have been on Bextra for the last two years. Now what?

[Veto!]

I take about 30 supplements daily, one of them tocotrienols, a form of E. Niacin is just B-3. I can't imagine any problem mixing them. I get tocotrienols and other exotic nutrients wholesale (almost) at a web outfit another freeper recommended a couple of years ago. I find them honest, quick with deliveries, and the lowest prices around:

http://www.beyond-a-century.com

They cater to body builders. Obviously that includes thee and me! LOL. Thir online site is hard to navigate, so I got their catalog. It's also hard to read, as many items are crammed into the smallest possible space on junky paper, but anything to keep those prices down! . I read the whole thing! The hassle pays off in savings.

I do buy a few things from http://www.vitacost.com, an outfit that sells well below retail and has a proprietary brand, Dr. Walker. Walker protein shakes are the best I've ever had, and are less than half as much as semi-comparable products at my health food store. The old Atkins shake was wonderful too, but the minute they lowered Doc Atkins into the ground, they cheapened the product and raised the price.

A disinterested cook, I make one meal a day a protein shake and dump in my amino acids and other supplements. Vitacost.com carries Rainbow Light as well.

I check out all my supplements with my doctor in Seattle. The only thing that raises his eyebrows is pregnenolone, a hormone precourser. He insists upon monitoring it. all the other stuff has his stamp of approval. In fact, his wife takes most of the stuff too. He's on the "best doctors in America" list yet again this year, for what it's worth.

[Spirited]

They're a day late and a dollar short on this. Those they characterize as "quacks" quacked about this stuff a long, long time ago.

Problem is, with the research out there now and available on the internet more people than ever are listening and discovering the verity of what is said.

[.38sw]

Looks like I missed it on the first go 'round. I'd laugh if it wasn't so true!

[WhyisaTexasgirlinPA]

Oh my gosh...........it has taken me almost 20 years to get my Marine to take any type of pain reliever for joint pain and now you tell me this one is off the list? #@#!@@$%!@$$

[Cold Heart]

Both the natural supplement manufacturers and the prescription drug manufacturers are in business to make money. I choose one over the other depending on which works the best with the least side affects. I have very good medical coverage, cost doesn't control my avenue of treatment choice. I have had surgery that sucessfully repaired one joint.
For arthritis, it has been the conventional prescription medicine that has caused the most harm to patients. Cortisone shots were given like candy which accelerated joint destruction. One medical study even suggested that over long term, patients that took aspirin, Ibuprophen and other OTC pain drugs had worse conditions of arthritis than those that took none.

Mayo clinic did a study on glucosamine and found that the stuff works. Other studies show that MSM, vitamin C and some of the other natural chemicals also work.

The sinister action is not hidden at the FDA, it's in the open. The scientist that blew the whistle on the Vioxx problem will probably loose his job.

[mountaineer]

Thanks, Nan. After physical therapy most of the summer, my back is a lot better than it was, but I'm sure the glucosamine would be beneficial.

[N. Theknow]

I hope you're kidding...

Gotcha, huh?

Say, you know, there was this one instance.....

[ol painless]

Dihydrogen monoxide alert!


http://www.dhmo.org/

[Hot Tabasco]

I almost never have headaches --- but sometimes certain wines --- just one glass --- will give me what I think could be a migraine

I had the same experience years ago with a certain wine I was drinking. My brother-in-law, who makes his own, explained what the problem was. It is due to a too high a level of sulfides or something like that in the wine. That is an indication of a bad brew.....

[Conservativegreatgrandma]

Six months? Try years. It's been 8 1/2 years since I've been to a doctor. I have lots of remedies. Try Vicks Vaporub for toe fungus. I can go on and on. Doctors nearly killed my sister.

[Nov3]

Calling someone a communist here is foul.

I was being sarcastic about how some here think that the corporate world can do no wrong.

[Nov3]

I agree with 99.99% of your posts; but on this issue, I'm afraid we part company. I simply don't see any sinister conspiracy on the part of the "evil pharmaceutical companies" to defraud the American public.

It is the culture. When a winner is declared (a new drug) it is protected at all costs. A culture is created that supports the drug and expands its market. It is the job of a corporation to expand its business and find new markets. This culture has rules written and unwritten.

If you are a hired researcher there are privacy agreements, the drug company owns the research etc. This is only common sense on their part. The corporation as would be expected hides bad research. It has repeatedly occurred and it has come to light only as a result of whistle-blowers and government investigation (mainly foreign). The Paxil and SSRI debacle in Britian is an example.

Second a lot of these researcher get their cheese researching these drugs. There is a profit motive here. Bad results - no more cheese. So when they come to a researcher wanting to do a study on say Zocor in patients with normal blood sugar and cholesterol what do you think the researcher is going to work hard for. The "right" results.

Third there is huge pressure to increase market in ANY corporation. Drug companies are no exception. The marketing department drives drug use and profits.

Fourth do you think you would want to be the squeaky wheel that pointed out the problems with say Vioxx before they were manifested in a GOVERNMENT study? You would be drummed out by every department in the entire company. Your career would be over in any pharmaceutical company. Also for some reason the parallel corporate sponsored study for some reason has not shown the 250 to 400% increase in heart attacks. I wonder why?

I could go on and on but the point is that the culture demands hiding faults, expanding the market, and pushing the drugs in every doctors office across the country. The FDA employees are hopelessly overworked and cannot and in some case will not aggressively find these faults.

Cox2s, SSRIs and statins are great drug for their use and have their place just not in every house. (There are a lot of houses all three are in.)

Also in every case we have seen recently there was no doubt a meeting where a few people sat around and decided it was bad business to look into some strong warning signals. I hope they reap what they sow.

I lost my left eye to Innovative Optic's Innovatome. During the course of the lawsuit documents of those meetings were discovered. (The hand written notes - the official typewritten minutes did not have any mention of it for some reason) People will sit in a meeting and for a hundred or so thousand a year they will make a decision to allow people to be blinded etc for more money. I know it for a fact. They will hide it from the people selling it. I know it for a fact. They will hide it from people who are training the doctors to employ it. I know it for a fact. They will hide it from the FDA and the FDA is not interested in it. I know it for a fact. It is ugly but true. I was one of the fortunate ones, I only lost the use of one eye.

That is also OK with a lot of people here which I find scary.

[Nov3]

Here is my incident. Note the tool was marketed to doctors as a new generation tool that could not be misassembled. My "incident" occurred 5/18/99 and they only got around to reporting it 2/23/00. I am sure it was an oversight on their part as was the other ~20 to 30 accidents of a similar nature they failed to report. Note also the other incident they refer to result in destruction of BOTH of the other patients corneas. That had to be a nice day for him/her.

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Adverse Event Report

INNOVATIVE OPTICS, INC. INNOVATOME MICROKERATOME

Model Number 500-0012-2

Event Description

Surgeon reported to co's medical director that the applanutor had been put on the sapphire upside down. The flap was so thick it had to be held back. Lasik was performed while holding the flap back. There was a perforation which caused leakage. Patient had minimal vision at post-op. Patient was doing well as of 7/11/99.

Manufacturer Narrative

Na see attached.

Manufacturer Narrative

Surgeon reported to co's medical director that the applanator was put on upside down. The flap was so thick it had to be held back. Lasik was performed on pt while holding the flap back. There was a perforation which caused leakage. Pt sutured. At post-op, there was significant edema and the pt had minimal vision at the time. Pt was doing well at 7/11/99. Please note that the first referenced event has been filed beyond the requested time frame. The second filing is within the prescribed time frame. The reason for this late report is as follows: upon co's initial review of the first event, co determined that, because co's microkeratome system did not "cause" the perforation described in the report, co did not feel it necessary to file. The excimer laser was the device that caused the perforation of the anterior chamber due to the thinness of the remaining cornea. Both cases clearly demonstrate improper assembly of co's device by the technician leading to deeper than normal cuts into the cornea. In any other incident of this nature, procedure would be to replace the corneal flap without proceeding with use of the excimer. This did not occur in either incident. Co has recently completed an extensive review of fda guidelines. Upon review of the first event, co determined a "contributory factor" in such an incident must be considered despite the operator error aspect, and as such should be reported. No h3 reference is given as device evaluation was not deemed necessary.

Search Alerts/Recalls    (After selecting, enter device information to search Alerts/Recalls)

new search  |  submit an adverse event report

Brand Name	INNOVATOME
Type of Device	MICROKERATOME
Baseline Brand Name	INNOVATOME
Baseline Generic Name	MICROKERATOME
Baseline Catalogue Number	900-9002
Baseline Model Number	900-9002
Other Baseline ID Number	NONE
Baseline Device Family	MICROKERATOME
Baseline Device 510(K) Number	K973294
Is Baseline PMA Number Provided?	No
Baseline Preamendment?	No
Transitional?	No
510(K) Exempt?	No
Shelf Life(Months)	NA
Date First Marketed	07/20/1998
Manufacturer (Section F)	INNOVATIVE OPTICS, INC. 6808 academy pkwy, ne bldg. a, suite one albuquerque NM 87109
Manufacturer (Section D)	INNOVATIVE OPTICS, INC. 6808 academy pkwy, ne bldg. a, suite one albuquerque NM 87109
Manufacturer Contact	dave davis 6808 e. academy pkwy, ne bldg. a, suite one albuquerque , NM 87109 (505) 341 -2577
Device Event Key	258488
MDR Report Key	267016
Event Key	250285
Report Number	1724318-2000-00003
Device Sequence Number	1
Product Code	HNO
Report Source	Manufacturer
Source Type	Company Representative
Remedial Action	Other
Event Type	Injury
Type of Report

Initial,Followup

Report Date

02/23/2000

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

Date FDA Received

02/23/2000

Is This An Adverse Event Report?

Yes

Is This A Product Problem Report?

No

Device Operator

Health Professional

Device MODEL Number

500-0012-2

Was Device Available For Evaluation?

No

Is The Reporter A Health Professional?

Yes

Was the Report Sent to FDA?

Yes

Date Report Sent to FDA

02/23/2000

Distributor Facility Aware Date

05/18/1999

Device Age

1 yr

Event Location

Outpatient Treatment Facility

Date Report TO Manufacturer

02/23/2000

Date Manufacturer Received

02/23/2000

Was Device Evaluated By Manufacturer?

No

Date Device Manufactured

02/01/1999

Is The Device Single Use?

No Answer Provided

Type of Device Usage

Reuse

Patient Outcome

Required Intervention 

Database contains data received through September 30, 2004

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Center for Devices and Radiological Health / CDRH

[FITZ]

That's why I think there probably is a chemical cause for many headaches --- I almost never get headaches but when I had that kind from the wine --- it was about as bad as I could imagine. I'd rather avoid the cause than try to cover up that kind of pain.

[kenth]

Got arthritis?, try the glucosamine, MSM, vit C, + other stuff in liquid form. Health food store, grocery store or feed store. Doesn't work for all types of arthritis but if it does it will actually promote healing.

There's a drug used by vets that is supposed to be available for human use soon - Adequan. Our dog has osteoarthritis in his back and our vet just started him on it. So far, it is starting to work well and we have high hopes it will give him back a good quality of life. It apparantly is a highly active form of glucosamine, one that is supposed to bind to damaged cartilage and replace joint fluid. If it actually works the way it is supposed to, it will go a long way in helping alleviate the root cause of back/joint pain instead of just masking the symptoms.

[Cold Heart]

Thank you for that info.

Now, where can I go to get some of your sarcasm?

Sarcasm heals.