Hi all,
Just wanted to let everyone know that I was able to pick up my medication
this morning.

Jenn

FDA urges new warnings for pain relievers
Combinations of over-the-counter drugs can cause serious side effects
The Associated Press
Updated: 5:43 p.m. CT Dec 19, 2006
WASHINGTON - Federal health officials cautioned Tuesday the tens of millions
of Americans who take popular over-the-counter pain pills of their
potentially serious side effects and released planned label changes intended
to warn of the sometimes deadly risks.

Aspirin, ibuprofen, acetaminophen and the other related over-the-counter
drugs remain safe and effective when used as directed, the Food and Drug
Administration said.

However, overdoses of acetaminophen can cause serious liver damage, even
death, the FDA said. For aspirin, ibuprofen and other nonsteroidal
anti-inflammatory drugs, there is a risk of gastrointestinal bleeding and
kidney injury even when patients take the correct dose. Those risks too are
linked to deaths, in this case thousands each year. The FDA cautioned the
risk is rare when compared to the number of patients who take the drugs.

Experts called the stepped-up warnings long overdue, since federal advisers
had called for similar label changes in 2002. An FDA official chalked it up
to the time required to write new regulations.

"Unfortunately, that is a very long process. That is one of the
disadvantages of the rule-making process," said Dr. Charles Ganley, director
of the FDA office that oversees nonprescription products.

Unwitting overdoses
The drugs are found in hundreds of medicines sold to treat pain, headache
and fever. Health officials worry that the wide availability of those
combination products can lead to patients unintentionally overdosing.
Doctors report cases of patients taking two or more medicines - say, one for
pain and another for flu symptoms - without knowing they both contain
acetaminophen.

The FDA has updated the labels on the drugs multiple times in the past to
warn patients of their risks. In 2002, FDA advisers recommended even further
changes. In 2004, some of the warnings contained in the new proposal were
included in pharmacy brochures and public service ads - a move that some
critics said at the time didn't go far enough.

The latest proposed changes largely would beef up and highlight those
warnings on the labels of the drugs. They also would require the more
prominent disclosure, using fluorescent or bold-faced type, the presence of
the drugs among a medication's ingredients.

"It's a step that's overdue and really reflects the consensus that came out
of the meeting four years ago, which is helping the consumer know what they
are taking," said Dr. Paul Watkins, a professor of medicine at The
University of North Carolina at Chapel Hill and a member of the 2002
advisory panel.

For acetaminophen, the labels also would warn of the risk of severe liver
damage if patients take more than the recommended dose or consume three or
more alcoholic drinks a day while on the drugs. The labels also would warn
patients not to take multiple medicines that contain acetaminophen. In any
given week, an estimated 48 million Americans take an acetaminophen product.

"People swallow these things like candy and they don't pay attention to the
number of pills they're taking - even when you question them about it," said
Dr. James Boyer, chairman of the board of the American Liver Foundation and
a Yale University professor of medicine.

Most popular painkillers
For aspirin, ibuprofen, naproxen and other nonsteroidal anti-inflammatory
drugs, or NSAIDs, their labels would have to contain additional warnings of
the risk of stomach bleeding. The labels would note the risk is higher in
patients older than 59, or in those who have stomach ulcers, take
blood-thinning drugs or steroids, use other drugs that contain an NSAID or
remain on the medications for an extended period. An estimated 17 million
Americans take an NSAID daily.

"Over-the-counter medicines are real medicines with real risks if misused.
As with all medicines, there can be risks associated with not following
label directions," said Elizabeth Assey, a spokeswoman for the Consumer
Healthcare Products Association, which represents nonprescription drug
manufacturers.

Acetaminophen is sold under the brand name Tylenol and in multiple generic
versions. Acetaminophen sends an estimated 56,000 people to the emergency
room each year, the FDA said. About 100 people die each year after
unintentionally overdosing on the drug.

Ibuprofen is sold under the brand names Advil and Motrin and in generic form
as well. Naproxen is best known as Aleve, but is also sold generically. The
NSAIDs are blamed for sending more than 200,000 Americans to the hospital
every year, and are linked to an estimated 16,000 deaths, the FDA said. The
agency said it would address the cardiovascular risks of nonprescription
NSAIDs in the future.

While all the affected drugs are available without a prescription, they also
are used in multiple combination products sold only with a doctor's note.
Those include narcotics, which can be addictive.

Experts have proposed "unbundling" acetaminophen from those products, said
Dr. William Lee, of the University of Texas Southwestern Medical Center.
They've also suggested limiting acetaminophen package sizes, something
already done in the United Kingdom, he said. The FDA is looking at both
issues, the agency's Ganley said.

The proposal appeared Tuesday on the FDA's Web site ahead of its expected
Dec. 26 publication in the Federal Register. Since it could take a year or
more for the rule to become final, the FDA said it strongly encouraged
companies to update their labels in the meantime, as some companies already
have done.

Vicodin ES -I believe has a high amount of Tylenol. There's 750mg of
Tylenol in VicodinES or the chemical name acetaminophen --It will be
listed as APAP on your bottle.  The other chemical in vicodin is
hydrocodone . So Vicodin ES is 7.5mg Hydrocodone & 750mg of Tylenol or
chemical name acetaminophen /APAP.It will look like this on your bottle
7.5/750mg..
Next time your DR. gives you Vicodin ask for a lower Tylenol amount .
They have low as 80mg Tylenol per pill available, 80mg is alot  lower
than 750mg per pill. They even make ibuprofen (advil)with
vicodin(hydrocodone)........ 5000mg I think is the standard limit on
acetaminophen (Tylenol) you liver can take a day.
Here's some of the available vicodin mixtures.
5/500mg---------7.5/375mg---------10/500mg----------15/80mg-----WHY the
hell Dr's keep prescribing the Vicodin ES' s gets me? they have much
lower tylenol/hydrocodone mixtures available out there. I dont know why
the pharmacist didnt recommend giving you lower Tylenol amounts in your
vicodin.

You'd think they'd love to give you Tylenol by the ton and kill you.
After all, isn't that the whole point of Tylenol-laced crap like
Vicodin -- kill the junkies with Tylenol as part of the Drug War.

Sure, you'll harm some non-junkies too, but you have to expect
"colateral damage" in War.

If there is a legitimate reason for mixing an opioid and APAP together
in one pill as is done with Vicodin or Percocet or Tylenol #3 etc.,
please explain the reasoning to me because the logic totally eludes me.

The pain-killing power of Vicodin certainly isn't coming from the
Tylenol; it's coming from the hydrocodone.  I can think of no reason to
add APAP other than to discourage junkies -- who likely aren't
discouraged as addicts tend to ignore things like their health &
safety.  So you just end up with junkies who have liver failure.

That sure doesn't sound like a nice way to treat your fellow human
beings, even if they happen to be raging addicts.  Maybe we can start
putting Tylenol in vodka to kill off drunkards next.