health.dailynewscentral.net
FDA Warns of Crestor Muscle Damage Risk
02 March 2005

The Food and Drug Administration (FDA) today issued a public health
advisory concerning the identified risks and benefits of Crestor
(Rosuvastatin calcium), a cholesterol-lowering drug.

The Crestor advisory is intended to notify the public of "potentially
significant emerging safety data," says Dr. Steven Galson, Acting
Director, Center for Drug Evaluation and Research (CDER).

Risk of Serious Muscle Damage

The FDA is updating information about the risk of rhabdomyolysis
(serious muscle damage) in patients taking Crestor, as well as other
statin drugs.

This is a well-known, rare adverse effect of all statins, the agency
notes. Extensive review of the large amount of data available to date
from controlled trials, as well as the latest post-marketing safety
information, indicates that patients taking recommended doses of
Crestor have a similar risk of rhabdomyolysis as patients on other
statin cholesterol treatments.

Crestor's manufacturer, Astra-Zeneca Pharmaceuticals, today revised
the package insert for Crestor, based on discussions with the FDA.

These changes re-emphasize recommendations made in the original label
about the need for physicians to consider using lower starting doses
of the drug in some individuals as a means of reducing the risk of
rhabdomyolysis, according to the FDA.

The revised labeling notes that this may be particularly important for
treating Asian American patients, since clinical trial data suggest
that they (along with patients on cyclosporine or patients with severe
renal insufficiency) may have higher drug levels and therefore be at
greater risk for muscle injury due to Crestor than the general
population.

Kidney Failure Risk

Kidney failure of various types also has been reported in patients
treated with Crestor, as well as other statins.

However, patients who are candidates for statin therapy (e.g.,
patients with diabetes, hypertension, atherosclerosis, and/or heart
failure) also may be at higher risk for kidney failure even when they
are not prescribed statin therapy. Based on FDA's review of these
cases and the available data from controlled trials, FDA cannot
confirm that recommended doses of statins, including Crestor, can
cause or worsen kidney failure.

Overall, FDA says it believes that potential benefits of statin drugs
(including Crestor) when used as labeled and indicated for the
treatment of elevated cholesterol (hypercholesterolemia) outweigh
their potential risks and provide an important treatment option for
millions of Americans at risk of heart disease.

FDA's Public Health Advisory is available online:
http://www.fda.gov/cder/drug/advisor...tor_3_2005.htm

FDA's Patient Information Sheet and Alert for Healthcare Professionals
also can be accessed on the Internet:
http://www.fda.gov/cder/drug/infopag...in/default.htm

"k brown" <zzzzz@nospam.com> wrote in message
news:nooc215ue8av8qok68jl9drbboqs756moq@4ax.com...

"George Conklin" <georgeconklin1@earthlink.net> wrote in news:wPBVd.16
$cN6.12@newsread1.news.pas.earthlink.net:

Anyone who is harmed by *any* medication will face difficult challenges.
Fortunately, even with this news, serious side effects from statins are
extremely low. The odds of a serious bleed from aspirin are much higher.

L.

k brown wrote:

Bullfeathers! It's been known for some time that the incidence of kidney
failure is a whopping 75x higher compared to other statins.


Just a casual observation: When drugs appear on this _Do Not Use_ list,
about 24 to 30 mos later, the FDA finally bans them.

http://www.worstpills.org/public/new...r.cfm?n_id=248

trivia: no one has a statin drug deficiency.
vitamin C is a natural statin

Jon von Leipzig wrote:



The "Other" DTCA Pharma Awards:
http://www.communitycatalyst.org/index.php?doc_id=786

The categories and winners of the Bitter Pill Awards for Exposing Drug
Company Manipulation of Consumers are:

Performance Anxiety Award:
For Exploitation of Male Fears of Inadequacy.
A three-way tie, going to the makers of Viagra, Levitra and Cialis

What ads for these drugs have in common is they all play on male fears
of impotence, and by association, with masculinity and virility. No
longer do they seem to focus on Erectile Dysfunction as a medical
condition, but instead on sexual desire, potency and
"mischievousness." These ads help demonstrate the misplaced
priorities of the drug industry as a whole.


Speak No Evil Award:
For Concealing Drug Risks and Benefits in the Name of Profits:

Shared by Merck, maker of Vioxx, and Pfizer, maker of Celebrex
By now the dangers associated with Vioxx and Celebrex are well known.
What is less well known is that Merck and Pfizer knew about the dangers
during their aggressive direct to consumer ad campaigns and chose to
hide them from the public. Merck used tactics such as a sales staff
training manuals with the title "Dodgeball Vioxx" which instructed
representatives how to evade doctors' questions about the
cardiovascular safety of Vioxx. The marketing campaigns for these two
drugs led millions of people who would have done just as well on a much
cheaper over the counter drug to pay top dollar for a drug that
potentially put them at great risk.

----------more----------


AND:


Posters from Canadian Women's Health Network
http://www.cwhn.ca/


Prescription for Profit:
http://www.whp-apsf.ca/pdf/whpDTCA_ad.pdf


No wonder they're jumping for joy:
http://www.whp-apsf.ca/pdf/whpDTCA2_ad.pdf


Zee

In article <1109880430.993597.55350@g14g2000cwa.googlegroups. com>,
"Zee" <zwalanga@yahoo.com> wrote:

Pretty damning stuff for sure. Sex always sells and our Puritan past
enable yet another generation to be confused via Hollywood et al.
What to do ? Perhaps seek out a wise croneŒs and elder ? Ah tribal
longing!

Meanwhile I do not believe pharmaceutical folks have anything like a
Hippocratic Oath. Too bad since they seem to running the heath care
business. Seems their restraints are legal in nature and ethics a
dream state.

Ethos and common sense must arise and they can and do usually when it is
very obviously needed. Meanwhile suffering rules the day.

The hummers have hit the gulf coast heading once again towards Zee.

Watch the Hummingbird progress here http://www.hummingbirds.net/map.html

William(Bill)

--
Zone 5 S Jersey USA Shade
--> http://www.ocutech.com/ For vision problems
http://www.truemajorityaction.org/si...c=jvLUJdP8H&b=
315914&msource=ustack

k brown wrote:
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~


Public Citizen Press Releases

Providing the latest information about Public Citizen activities

-------------------------------------------



March 2, 2005



FDA Shows Dangerous Cowardice in Crestor Announcement


Statement of Sidney M. Wolfe, MD, Director, Public Citizen's Health
Research Group



Today's announcement by the U.S. Food and Drug Administration (FDA)

concerning revised labeling of the cholesterol-lowering drug Crestor is

yet another example of the agency's dangerous cowardice in failing to

adequately protect people in this country from uniquely dangerous

prescription drugs. Like statements from AstraZeneca, the FDA's

statement is replete with false and misleading information. Rather than

responding in a public health-positive manner to our March 2004
petition

and banning this drug, the FDA has done exactly what AstraZeneca wanted

with minimal labeling changes and surely has pleased one of the drug

companies contributing to the $150 million in drug industry funding
that

the FDA is receiving this year for drug review.



Since the last supplement to our petition to ban Crestor (submitted in

October 2004), which was based on adverse reaction reports through

August 26 of last year, there have been an additional 52 U.S. cases of

life-threatening muscle damage (rhabdomyolysis) reported to the FDA and

an additional 12 U.S. cases of kidney failure or impairment in people

not having rhabdomyolysis reported to the agency up to the end of

January of this year. The total of such U.S. cases reported since the

drug was first marketed in September 2003 is now 117 cases of

rhabdomyolysis and 41 cases of kidney failure, both higher than seen

with the other currently marketed statins. Because of concerns about
the

safety of Crestor, several countries, including Germany, Norway and

Spain, have not approved the drug.



Although the increased rate of rhabdomyolysis is not as high as that of

the now-banned Baycol, the FDA is well aware that the rate is higher

than that of the other statins, a fact it covers up by saying the rate

is "similar." The FDA statement also includes other "facts"
that

are extremely misleading if not false:



FDA Statement: "Data available to date from controlled trials, as

well as post-marketing safety information, indicate that the risk of

serious muscle damage is similar with Crestor compared to other
marketed

statins."



Response: Crestor was the only statin that caused rhabdomyolysis at any

dose in clinical trials prior to approval. (The cases occurred at 80
mg,

a dosage not approved, but most of the post-marketing cases are

occurring at 10 or 20 mg.)



FDA Statement: "Mild, transient proteinuria (or protein in the urine,

usually from the tubules), with and without microscopic hematuria

(minute amounts of blood in the urine), occurred with Crestor, as it
has

with other statins, in Crestor's pre-approval trials."



Response: Although the FDA admits that with Crestor, "The frequency

of occurrence of proteinuria appeared dose-related," it fails to

mention that this dose-related increase in proteinuria and hematuria

(blood in the urine) was seen only with Crestor and not with any other

statin.



FDA Statement: "In clinical trials with doses from 5 to 40 mg daily,

this effect was not associated with renal impairment or renal failure

(i.e., damage to the kidneys)."



Response: (from FDA medical officer during the July 2003 FDA hearing on

Crestor approval): "These three cases of renal insufficiency of

unknown etiology are of concern because they present with a clinical

pattern, which is similar to the renal disease seen with rosuvastatin
in

these clinical trials. ... Proteinuria and hematuria could be
potentially

managed with regular urinalysis screening. However, if they are the

signals for the potential progression to renal failure in a small
number

of patients, this may represent an unacceptable risk since currently

approved statins do not have similar renal effects." (emphasis

added)



Rather than being a "Public Health Advisory," as the announcement

is titled, this FDA statement is more like an AstraZeneca Health

Advisory. In its inability to serve two masters, the FDA has sided once

again with its funders in the drug industry.



###

"listener" <listener@nospam.net> wrote in message
news:Xns960E67C86EBD6listenernospamnet@38.144.126. 103...
How many people do you know who have been disabled for 7 years by an aspirin
bleed?

I live with someone disabled for 7 years by Lipitor.

I have two friends who have lost their homes this calendar year due to
statin damage disabling them to the point that they were unable to work.
Two others this calendar year who are in the process of determining the
degree of statin cognitive damage they have suffered (both had NP tests and
scored below the 10 percentile), one in the process of losing his job at 52
years of age due to the statin damage.

How many people are you acquainted with who have lost all income due to
aspirin bleed?

How many people do you know who have lost their homes because of aspirin
bleed?

Statin damage to muscles, nerves, and brain function causes lasting
disability that is not comparable to aspirin bleed.

"Sharon Hope" <shope@anet.net> wrote in
news:vvKdnXwj6MdbbLrfRVn-rw@comcast.com:

Au contraire, Mrs. Hope.

Aspirin:

Damage to the lining of your stomach, prolonged bleeding time, wheezing,
breathlessness, ringing in the ears, hearing loss, chronic catarrh &
runny nose, headache, confusion, nausea, vomiting, GI upset, GI bleeding,
ulcers, rash, allergic reactions, hives, bruising, abnormal liver
function tests, liver damage, and hepatitis. Kidney Damage, severe
metabolic derangements, respiratory and central nervous system effects,
strokes, fatal hemorrhages of the brain, spleen, liver, intestines &
lungs and DEATH.

300 to 500 reported deaths per year: (taken as directed).

[BTW Sharon, death is a serious disabling side effect.]

Ulcers caused by NSAIDs, including aspirin kill about 16,500 people in
the United States each year (reported in the New England Journal of
Medicine).

Can you lose your home when you're dead?
Can you work when you're dead?
Can you have cognitive damage tests when you're dead?
Can you lose your job when your dead?
Can you lose your income when you're dead?
Can you have a lasting diability when you're dead?

Your personal and touching story has no bearing on the fact that aspirin
debilitates and kills more people yearly than statins.


NOTE: The benefits of aspirin for cardiovascular and cerebrovascular
indications has been shown in many studies. I am not against the use of
aspirin. The risks of any medication need to be weighed with the
benefits.

L.

Muscle weakness and damage via statins is well-known
and printed in every ad. An elderly relative of mine
lost the ability to walk due to leg weakness.

Likely your relative also suffered nerve damage. Neuromuscular damage by
statins is part of why it is so disabling, as the nerve damage takes much
longer to heal, and some is possibly permanent.

Your relative might benefit from a neurologist consultation, particularly if
the neurologist is familiar with the neurotoxic effects of statins.

"rick++" <rick303@hotmail.com> wrote in message
news:1109955077.309936.215290@o13g2000cwo.googlegr oups.com...

shope@anet.net wrote:


man14val1791@duskmail.com