Posted on 01/15/2011 1:08:23 PM PST by EBH
Federal health regulators are limiting a key ingredient found in Vicodin, Percocet and other prescription painkillers that have been linked to thousands of cases of liver damage each year.
The Food and Drug Administration said Thursday it will cap the amount of acetaminophen in the drugs at 325 milligrams per capsule. Current products on the market contain doses of up to 700 milligrams.
Acetaminophen is a ubiquitous pain reliever found in Tylenol, Nyquil and thousands of other medicines used to treat headaches, fever and sore throats. The ingredient is also used at larger doses in prescription combination drugs that mix it with narcotic drugs like oxycodone.
Those products are not dangerous by themselves but can cause toxic overdoses when patients combine them with a second acetaminophen-containing drug like Tylenol.
FDA officials said the labeling on prescription drugs often does not make it clear that they contain acetaminophen, instead using abbreviations for the ingredient like 'APAP.'
"One of the real challenges we have is that patients taking these products don't know they're taking acetaminophen at all," said FDA deputy director for new drugs, Dr. Sandra Kweder, in a telephone briefing with reporters. "They don't realize that they are overdosing."
The FDA said it is working with pharmacies and other medical groups to develop standard labeling for acetaminophen, though that is not part of Thursday's action.
Agency officials said the drugs will still be effective at lower doses.
"The amount of acetaminophen in these products has gradually crept up over the years," Kweder said. "If you look at these products 20 to 30 years ago, many did not contain high doses of acetaminophen."
(Excerpt) Read more at news.yahoo.com ...
It was a panel of physicians who made the recommendation to the FDA. Actually, they recommended totally doing away with combination drugs like Vicodin and recommended that pain killers include only the primary active ingredient, such as hydrocodone, etc.
Tylenol is the only pain medicine I will take and I try not to take that unless I really need it. I wouldn’t be surprised if a lot of liver damage associated with Tylenol is actually a combination of Tylenol and other drugs including alcohol alcohol. People are on more and more drugs these days. Some folks may take 20 or more different drugs a day; for example, here’s a fairly common regimen: lasix, zocor, oxycodone, tylenol, zetia, synthroid, priolosec, lisinopril, lopressor, cardizem, digoxin, magnesium supplements, potassium supplements, folic acid, coumadin, singulair, metphormin, glipizide, colace, celexa, xanex, ambien, albuterol, and atrovent. The only difference between a poison and a medicine is the dosage.
The Food and Drug Administration said Thursday it will cap the amount of acetaminophen in the drugs at 325 milligrams per capsule.
I am 59 going on 60 and I do not take any prescription medications.
About twice a year I will take something for heartburn releif.
About twice a tear I will take 2 aspirins for headache relief.
Am I all that unusual?
So many "professionals" say acetaminophen is safe.....with the caveat..."if taken as directed".
Therefor......I take aspirin....therefor, my liver survives....
Actually, long term aspirin use kills many thousands of people annually due to gastrointestinal bleeding.
Ibuprofen (Advil) can harm the kidneys if taken in large doses over a period of time. Aspirin is the safest pain reliever for most folks.......but it does act as a blood thinner....so if you’re on Plavix....it wouldn’t be a good idea.
“FDA deputy director for new drugs, Dr. Sandra Kweder...”
Did you think a bunch of paper pushers made this decision? Too many conservatives think the govt is nothing but paper pushing bureaucrats instead of there being many highly trained professionals in medicine, engineering, chemists, biologists, physicists etc., etc., etc. Yes, some of them are political; most just want to do their research.
While the FDA is one of the more ‘nanny’ agencies, it occasionally does some good.
Remember as you're writhing in excruciating pain, you're helping keep double-digit IQ bureaucrats in a six-figure retirement lifestyle.
Together We Thrive.
I would think anything.....if taken in large doses would harm you. I grew up on Bayer aspirin and never recall anyone having problems.....then along came Tylenol. They couldn't get a foot into the market until a mass hysteria was created over Reye's syndrome.
BTW, I'm very suspicious of reports which state "many thousands of deaths" having been documented as aspirin-related without a comorbidity of ulcers or an overdose. Do you have a website which has the scientific data on that?
You are correct, I take 10/650 hydrocodone (generic Lorcet) for chronic and severe pain. I already know that my doc will accommodate me by adjusting the number of pills prescribed accordingly. She is very familiar with the pain I have and has offered Oxycontin, which I don't want to use until and unless it becomes absolutely necessary.
These decisions should properly be left up to physicians and their patients. As usual the gov thinks it knows best.
People dying from cancer usually just take narcotics not combined w/Tylenol.
I doubt that. Maybe if you abuse it and take tons and tons of them. Or if you have gastrointestinal problems in the first place.
My doctor actually prescribes one small aspirin (81 mg) a day to thin the blood and lessen the chances of blood clots and strokes.
I don’t exceed the recommended dosages, or take it more often than recommended. Never had any problems. No medicine is absolutely or universally safe, but I think that for most people aspirin is less risky than tylenol in similar amounts.
They aren’t lowering the dose of codiene or whatever the main ingredient is, just the Acetaminophen.
So instead of 10/650 generic Lorcet, you’ll get 10/325 generic Norco. You can take some Tylenol to make up the acetaminopen if you want to.
I agree. But it is very hard to get away from aspertame.
I like diet pop. The only ones I've found that don't have aspertame are Diet Rite and Cheerwine. They both use Splenda.
So did mine. He also told me to stay away from aspirin otherwise as too much of it could cause stomach irritation. About two years later I was in his office for a checkup. I had been throwing up and my stomach hurt... you guessed it!
Not yet bleeding but on it's way. Off the aspirin, on the antacids, bland diet, in six months I was fine. Even a low dose buffered aspirin can cause trouble over time especially if you are under stress.
You may doubt, but keep an eye on your stomach. If it starts to hurt, burn or you start throwing up for no reason go see your doctor.
Much easier to fix before the bleeding starts!
Like so often that it happens to me, (as I get older) I misunderstood the article to mean that they were removing the codone part. I went back before you replied and that time I got it. You're right, I don't care that they are taking some Tylenol out of it.
I asked a pharmacist once if it was available with an aspirin mix, thinking to fulfill the 85 mg. dose of aspirin I take daily. He said it was but was very expensive. That doesn't sound right to me and I'm not sure he knew what he was talking about.
That sounds like a very sensible thing to do.
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