 |  |
 |  |  | |||||||
|
--- FDA Warns of Crestor Muscle Damage Risk
"k brown" news:nooc215ue8av8qok68jl9drbboqs756moq@4ax.com... > 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. > If you are one who is harmed by statins, your life is ruined.
"George Conklin" $cN6.12@newsread1.news.pas.earthlink.net: > > "k brown" > news:nooc215ue8av8qok68jl9drbboqs756moq@4ax.com... >> 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. >> > If you are one who is harmed by statins, your life is ruined. > 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.
"listener" news:Xns960E67C86EBD6listenernospamnet@38.144.126.103... > "George Conklin" > $cN6.12@newsread1.news.pas.earthlink.net: > >> >> "k brown" >> news:nooc215ue8av8qok68jl9drbboqs756moq@4ax.com... >>> 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. >>> >> If you are one who is harmed by statins, your life is ruined. >> > > 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. 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" news:vvKdnXwj6MdbbLrfRVn-rw@comcast.com: > > "listener" > news:Xns960E67C86EBD6listenernospamnet@38.144.126.103... >> "George Conklin" >> news:wPBVd.16 $cN6.12@newsread1.news.pas.earthlink.net: >> >>> >>> "k brown" >>> news:nooc215ue8av8qok68jl9drbboqs756moq@4ax.com... >>>> 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. >>>> >>> If you are one who is harmed by statins, your life is ruined. >>> >> >> 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. > > 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. > > > > 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.
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 1 2 Next » 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
|
| ||||||||
 |  |
