If you are one who is harmed by statins, your life is ruined.

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/newsletter.cfm?n_id=248

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

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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.



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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.