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FDA Adds More Warnings for Lipitor, Crestor, and Zocor
WASHINGTON -- Statins may cause drug-drug interactions for patients taking drugs to treat HIV/AIDS or hepatitis C, according to a new statin warning from the FDA.
The agency singled out atorvastatin (Lipitor), rosuvastatin (Crestor), and simvastatin (Zocor) for the new warnings and restated a warning about mixing lovastatin (Mevacor) with HIV and HCV drugs.
Today's FDA safety communication follows label changes announced Tuesday that added cautions about new onset diabetes and transient memory problems for users of any of the cholesterol-lowering drugs in the statin class.
The FDA said that protease inhibitors taken with atorvastatin, rosuvastatin, simvastatin, or lovastatin increase the concentration of statins in the blood, which increases the risk for muscle injuries, including risk for rhabdomyolysis, which can cause permanent damage to the kidneys.
Specifically, the agency said atorvastatin is contraindicated with tipranavir plus ritonavir, and telaprevir and should be used with caution -- at the lowest effective dose -- among patients taking lopinavir plus ritonavir.
For patients taking darunavir plus ritonavir, fosamprenavir, forsamprenavir plus ritonavir, or saquinavir plus ritonavir, the atorvastatin dose should be limited to 20 mg daily.
In patients taking nelfinavir, daily atorvastatin should not exceed 40 mg.
Rosuvastatin should be limited to 10 mg daily in patients taking altazanavir with or without ritonavir or lopinavir plus ritonavir.
The FDA said simvastatin -- like lovastatin -- is contraindicated in patients taking "HIV protease inhibitors, boceprevir or telaprevir."
hector
The agency singled out atorvastatin (Lipitor), rosuvastatin (Crestor), and simvastatin (Zocor) for the new warnings and restated a warning about mixing lovastatin (Mevacor) with HIV and HCV drugs.
Today's FDA safety communication follows label changes announced Tuesday that added cautions about new onset diabetes and transient memory problems for users of any of the cholesterol-lowering drugs in the statin class.
The FDA said that protease inhibitors taken with atorvastatin, rosuvastatin, simvastatin, or lovastatin increase the concentration of statins in the blood, which increases the risk for muscle injuries, including risk for rhabdomyolysis, which can cause permanent damage to the kidneys.
Specifically, the agency said atorvastatin is contraindicated with tipranavir plus ritonavir, and telaprevir and should be used with caution -- at the lowest effective dose -- among patients taking lopinavir plus ritonavir.
For patients taking darunavir plus ritonavir, fosamprenavir, forsamprenavir plus ritonavir, or saquinavir plus ritonavir, the atorvastatin dose should be limited to 20 mg daily.
In patients taking nelfinavir, daily atorvastatin should not exceed 40 mg.
Rosuvastatin should be limited to 10 mg daily in patients taking altazanavir with or without ritonavir or lopinavir plus ritonavir.
The FDA said simvastatin -- like lovastatin -- is contraindicated in patients taking "HIV protease inhibitors, boceprevir or telaprevir."
hector
Smoking kills how many U.S. citizens a year? Smoking has no nutritional, or any other value in fact except to make to make you smell like an ash tray...yet how many still smoke?
"Tobacco use is the single most preventable cause of death and disease in the United States. An estimated 46 million American adults currently smoke cigarettes and annually cigarette smoking causes approximately 443,000 deaths - 1 in 5 deaths.. For every person who dies from tobacco use, another 20 suffer with at least one serious tobacco-related illness. In 2004, this addiction cost the nation more than $96 billion per year in direct medical expenses as well as more than $97 billion annually in lost productivity."
There is a lot of educating to be done.
hector
"Tobacco use is the single most preventable cause of death and disease in the United States. An estimated 46 million American adults currently smoke cigarettes and annually cigarette smoking causes approximately 443,000 deaths - 1 in 5 deaths.. For every person who dies from tobacco use, another 20 suffer with at least one serious tobacco-related illness. In 2004, this addiction cost the nation more than $96 billion per year in direct medical expenses as well as more than $97 billion annually in lost productivity."
There is a lot of educating to be done.
hector
"most PT are not compliant with diet"
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I think that is one reason doctors go straight to the statins. They figure the patient is not going to change his way of eating and exercizing and smoking, so go to the statins as a front line without trying anything else. I think that is true in many cases. (Some people I know are like that, diabetics who eat sweets daily or twice daily even though they know better).
Just because some people may not be compliant with diet modification and exercize, does not mean the doctor should make no efforts at education about these factors and encourage diet changes and exercise. It is easier to order the statins. However, I do think at least several people would be willing and able to lower their cholesterol via diet and exercise if they were given the necesary information and if the instructions were livable and doable. Personally, I think telling people to cut out all fat is not going to work. People feel deprived and the body wants a little fat. I think cutting down on fats is the key (with cutting down, not cutting out, as the key). Other than effective education, I do not know how you get people away from fast foods, junk foods, and processed foods, all of which contribute to high cholesterol. I was lucky enough that I never really liked sweets, even as a kid. I grew up in the country with little money and no extra food. This meant no extras such as ice cream toppings, frostings, a lot of sweets, junk food (chips, sodas, etc.), more than one serving of everything, etc. my mother made all of the bread and made all of the food from scratch. We had no processed foods even though they were available. We had a huge garden so we had a lot of fresh vegetables and we lived on a lake and ate fish all summer. So I learned early on to like the good foods and not get addicted to the detrimental foods like many kids do these days. After college I moved to SF and was involved in the early food co-ops (it was called the food conspiracy at that time). Everyone I knew was eating healthy, whole grain foods and a lot of fresh fruits and vegetables and organic foods. I have just continued in that vein for the past 45 years. So, to be honest and fair, I did not have to alter major bad habits. However, I did have to get off my butt and exercise and I did cut down on fats and amounts of food.
I think diet and nutrition education (in the doctor's office or clinic) probably needs to be fine tuned. I think it is outdated. People need to understand exactly how what they eat affects their bodies. I also think they need to tailor the food modifications to the patient, not the patien to the strict regimented diet. If people can be encouraged and assisted in cutting down and cutting out (or mostly out) without feeling deprived and without getting cravings, most will do it, I think.
As a nation the US better do something quick considering the growing number of obese people and the growing numbers of people with Type II diabestes.
------------------------------------------------
I think that is one reason doctors go straight to the statins. They figure the patient is not going to change his way of eating and exercizing and smoking, so go to the statins as a front line without trying anything else. I think that is true in many cases. (Some people I know are like that, diabetics who eat sweets daily or twice daily even though they know better).
Just because some people may not be compliant with diet modification and exercize, does not mean the doctor should make no efforts at education about these factors and encourage diet changes and exercise. It is easier to order the statins. However, I do think at least several people would be willing and able to lower their cholesterol via diet and exercise if they were given the necesary information and if the instructions were livable and doable. Personally, I think telling people to cut out all fat is not going to work. People feel deprived and the body wants a little fat. I think cutting down on fats is the key (with cutting down, not cutting out, as the key). Other than effective education, I do not know how you get people away from fast foods, junk foods, and processed foods, all of which contribute to high cholesterol. I was lucky enough that I never really liked sweets, even as a kid. I grew up in the country with little money and no extra food. This meant no extras such as ice cream toppings, frostings, a lot of sweets, junk food (chips, sodas, etc.), more than one serving of everything, etc. my mother made all of the bread and made all of the food from scratch. We had no processed foods even though they were available. We had a huge garden so we had a lot of fresh vegetables and we lived on a lake and ate fish all summer. So I learned early on to like the good foods and not get addicted to the detrimental foods like many kids do these days. After college I moved to SF and was involved in the early food co-ops (it was called the food conspiracy at that time). Everyone I knew was eating healthy, whole grain foods and a lot of fresh fruits and vegetables and organic foods. I have just continued in that vein for the past 45 years. So, to be honest and fair, I did not have to alter major bad habits. However, I did have to get off my butt and exercise and I did cut down on fats and amounts of food.
I think diet and nutrition education (in the doctor's office or clinic) probably needs to be fine tuned. I think it is outdated. People need to understand exactly how what they eat affects their bodies. I also think they need to tailor the food modifications to the patient, not the patien to the strict regimented diet. If people can be encouraged and assisted in cutting down and cutting out (or mostly out) without feeling deprived and without getting cravings, most will do it, I think.
As a nation the US better do something quick considering the growing number of obese people and the growing numbers of people with Type II diabestes.
Pooh you should be proud of yourself .That's very good that you could do that . I wish DRs did more education around diet. They should try that frist but like you said most PT are not compliant with diet
While I do think statins may be indicated in several situations and for some patients, I do think the statins are over prescribed. For doctors it is an easy fix and for the patients it seems easy too. Just take a pill and no diet , weight or smoking modifications are needed. I think diet modification and exercise should be tried first. (If one smokes, that should stop.)
A doctor wanted to put me on statins about 3 years ago. I said no, my liver enzymes had been elevated in the past and I did not want to go on them. Plus I hate taking pills. I said let me try to lower it by diet first. He sad, "Okay, but diet change won't work." Frankly, I am not sure where he got that idea. He was young, so maybe the was too young to remember when people did modify their diets and drop their cholesterol. Anyway, I changed a few things in my diet, mostly reduced the amount of some things I was eating, and added more fiber such as cooked rolled oats (the regular kind, not the quick cooking). I also started walking about 3 miles a day. After just about 6 months I lost 30 pounds and my cholesterol dropped 67 points. Note, I did not do a real strict diet with no fat. I still ate bacon on occasion (1 piece) and I always had half and half in my coffee. Mostly what I did was cut down on butter, the bacon, the amount of meat I ate, and other fats. I already was in the habit of cutting all fat off my meat (had done that for years). I also never ate junk food, fast food, or processed food. (I had never eaten that stuff. ) So, I surprised that pessimistic know it all doctor, lol.
I just think diet modification and excercise should be tried first. I look at many people around me and many are on statins. Yet they eat all the fat on their meat and a lot of it, eat deep fried foods (Kentucky Fried Chicken), eat fast foods and junk foods and tons of sweets. They get no exercize. They are overweight and several/most have high blood pressure and Type II diabetes as well as high cholesterol. It seems to me that diet modification and exercize would help all three of those problems.
If the diet and exercise don't work, then try some statins, but don't just start someone on statins without a second thought or without considering other possible/probable treatments.
A doctor wanted to put me on statins about 3 years ago. I said no, my liver enzymes had been elevated in the past and I did not want to go on them. Plus I hate taking pills. I said let me try to lower it by diet first. He sad, "Okay, but diet change won't work." Frankly, I am not sure where he got that idea. He was young, so maybe the was too young to remember when people did modify their diets and drop their cholesterol. Anyway, I changed a few things in my diet, mostly reduced the amount of some things I was eating, and added more fiber such as cooked rolled oats (the regular kind, not the quick cooking). I also started walking about 3 miles a day. After just about 6 months I lost 30 pounds and my cholesterol dropped 67 points. Note, I did not do a real strict diet with no fat. I still ate bacon on occasion (1 piece) and I always had half and half in my coffee. Mostly what I did was cut down on butter, the bacon, the amount of meat I ate, and other fats. I already was in the habit of cutting all fat off my meat (had done that for years). I also never ate junk food, fast food, or processed food. (I had never eaten that stuff. ) So, I surprised that pessimistic know it all doctor, lol.
I just think diet modification and excercise should be tried first. I look at many people around me and many are on statins. Yet they eat all the fat on their meat and a lot of it, eat deep fried foods (Kentucky Fried Chicken), eat fast foods and junk foods and tons of sweets. They get no exercize. They are overweight and several/most have high blood pressure and Type II diabetes as well as high cholesterol. It seems to me that diet modification and exercize would help all three of those problems.
If the diet and exercise don't work, then try some statins, but don't just start someone on statins without a second thought or without considering other possible/probable treatments.
When after tx my cholesterol spiked up to almost 300 after being low all of my life, I fought taking them. However, after taking Lipitor for two months it went down to 200.
So, after tx it might be a much needed thing and I just wouldn't want to discourage anyone to take them then.
So, after tx it might be a much needed thing and I just wouldn't want to discourage anyone to take them then.
Glad the ticker seem to be working fine..you certainly don't need that as well as what you are going through .
I would agree with you about the statinsbeing a much needed therapy for many folks ,however it seems that they are somewhat over prescribed as a front line defense these days ,instead of looking at diet .weight ,smoking etc and even with only slightly elevated levels.
I have discussed this with my Hepa as well as my PCP ,many times and they both have similar thoughts ,,that is when my PCP is not busy being wined and dined by the fabulous looking pharma sales reps..
Hope you are comfortable today friend...
Will
I would agree with you about the statinsbeing a much needed therapy for many folks ,however it seems that they are somewhat over prescribed as a front line defense these days ,instead of looking at diet .weight ,smoking etc and even with only slightly elevated levels.
I have discussed this with my Hepa as well as my PCP ,many times and they both have similar thoughts ,,that is when my PCP is not busy being wined and dined by the fabulous looking pharma sales reps..
Hope you are comfortable today friend...
Will
Will, though I don't know much about statins except how popular they are, I have heard they really have been a breakthrough for those with cardio issues. And as we know, heart disease is the number one killer for both men and women.
Lucky for me my cardi tests have all indicated I am in perfect health as far as cardio sees it. Of course I have low cholesterol due to liver damage as my liver doesn't produce it as much as it should and my blood pressure is about 100/80 which always get the nurse to say "wow, good blood pressure." Even my stress tests are perfect.
Too bad my liver is killing me as the rest of me is in very good health. haha
Though I am thankful for that. As any additional co-diseases only makes everything about liver disease and transplant a whole lot worse. I have enough on my plate as it is.
Hector
Lucky for me my cardi tests have all indicated I am in perfect health as far as cardio sees it. Of course I have low cholesterol due to liver damage as my liver doesn't produce it as much as it should and my blood pressure is about 100/80 which always get the nurse to say "wow, good blood pressure." Even my stress tests are perfect.
Too bad my liver is killing me as the rest of me is in very good health. haha
Though I am thankful for that. As any additional co-diseases only makes everything about liver disease and transplant a whole lot worse. I have enough on my plate as it is.
Hector
Thx. Hector.
Statins are another very much over -prescribed medication IMO..with a whole variety of side effects,irrespective of the contraindications with HCV therapy meds
They have become a financial bonanza in the last 10 years for Pharma.
Will
Statins are another very much over -prescribed medication IMO..with a whole variety of side effects,irrespective of the contraindications with HCV therapy meds
They have become a financial bonanza in the last 10 years for Pharma.
Will
Good catch here. And to think just a few years ago there was talk of putting statins into public drinking water.
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