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--- FDA Warns of Crestor Muscle Damage Risk
In article <1109880430.993597.55350@g14g2000cwa.googlegroups.com>, "Zee" > Jon von Leipzig wrote: > > k brown wrote: > > > 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 > > > > > 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. > > > > > > 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 > > > > > 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 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/site/pp.asp?c=jvLUJdP8H&b= 315914&msource=ustack
k brown wrote: > 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/advisory/crestor_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/infopage/rosuvastatin/default.htm ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ 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. ###
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++" news:1109955077.309936.215290@o13g2000cwo.googlegroups.com... > 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. >
shope@anet.net wrote: > 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++" > news:1109955077.309936.215290@o13g2000cwo.googlegroups.com... man14val1791@duskmail.com Start « Previous 1 2 Related Discussion: Symptoms (2 posts) dental: implants vs cantilever bridge for type 1 diabetic (1 posts) Morbid Obesity linked to Heart Failure and High Mortality (1 posts) Petrana Voice Commands for DVD 1.0 (2 posts) Top Discussions From Our Archives FDA announces H. Stone...wrong all along Ayurvedic woes raise new questions about drug agency oversight Noncompliance "pervasive" following obesity surgery Pfizer Suspends Celebrex Ads - U.S. FDA Other Discussion Categories Diabetes Symptoms Health Care Policy Health Care Providers HMO Arthritis Symptoms Oops!!! Unexpected Error While Reading the Feed
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