回复angle立普妥FDA最新警告
angle你好，谢谢你的发表，我想这才是论坛的目的，有争议才是正常的，我们要用好的药品来治疗疾病，但要尽量避开副作用，不要太过依赖药品。我不知道你给我的二份资料的发表时间，但我想请法国的阿马伦科教授(你能帮我联系他吗)看看这份FDA在2012。2。28的声明，今天是五月十九，所以应该是最新的。因为阿马伦科教授指大量应用atorvastatin在临床上几乎没有毒副作用。 FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs
Facts about statins
A class of prescription drugs used together with diet and exercise to reduce blood levels of low-density lipoprotein (LDL) cholesterol (“bad cholesterol”)
Marketed as single-ingredient products, including Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin)
Also marketed as combination products, including Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release), and Vytorin (simvastatin/ezetimibe)
Safety Announcement
Additional Information for Patients
Additional Information for Healthcare Professionals
Data Summary
Lovastatin Dose Limitations
References
Safety Announcement
[2-28-2012] The U.S. Food and Drug Administration (FDA) has approved important safety label changes for the class of cholesterol-lowering drugs known as statins. These changes were made to provide the public with more information for the safe and effective use of statins and are based on FDA’s comprehensive review of the statin class of drugs (see Data Summary below). The changes include the following:
Infographic About Cholesterol and Statins1
2
Monitoring Liver Enzymes
Labels have been revised to remove the need for routine periodic monitoring of liver enzymes in patients taking statins. The labels now recommend that liver enzyme tests should be performed before starting statin therapy and as clinically indicated thereafter. FDA has concluded that serious liver injury with statins is rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing serious liver injury.
Adverse Event Information
Information about the potential for generally non-serious and reversible cognitive side effects (memory loss, confusion, etc.) and reports of increased blood sugar and glycosylated hemoglobin (HbA1c) levels has been added to the statin labels. FDA continues to believe that the cardiovascular benefits of statins outweigh these small increased risks.
Drug Interactions
The lovastatin label has been extensively updated with new contraindications (situations when the drug should not be used) and dose limitations when it is taken with certain medicines that can increase the risk for muscle injury (see Lovastatin Dose Limitations below).
Healthcare professionals should refer to the drug labels for the latest recommendations for prescribing statins (also see Additional Information for Healthcare Professionals below). Patients should contact their healthcare professional if they have any questions or concerns about statins.
Additional Information for Patients
The statin drug labels have been revised to provide patients with more information on the safe and effective use of statins. Patients should be aware of the following information:
There have been rare reports of serious liver problems in patients taking statins. Patients should notify their healthcare professional right away if they have the following symptoms: unusual fatigue or weakness; loss of appetite; upper belly pain; dark-colored urine; or yellowing of the skin or the whites of the eyes.
Memory loss and confusion have been reported with statin use. These reported events were generally not serious and went away once the drug was no longer being taken.
Increases in blood sugar levels have been reported with statin use.
Certain medicines should never be taken (are contraindicated) with lovastatin (Mevacor) (see Lovastatin Dose Limitations below).
Patients should contact their healthcare professional if they have any questions or concerns about statins.
Patients should report side effects from the use of statins to the FDA MedWatch program, using the information in the "Contact FDA" box at the bottom of the page.
Additional Information for Healthcare Professionals
Healthcare professionals should perform liver enzyme tests before initiating statin therapy in patients and as clinically indicated thereafter. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment, therapy should be interrupted. If an alternate etiology is not found, the statin should not be restarted.
There have been rare post-marketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These reported symptoms are generally not serious and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).
Increases in glycosylated hemoglobin (HbA1c) and fasting serum glucose levels have been reported with statin use.
Healthcare professionals should follow the recommendations in the lovastatin label regarding drugs that may increase the risk of myopathy/rhabdomyolysis when used with lovastatin (see Lovastatin Dose Limitations below).
Healthcare professionals should report adverse events involving statins to the FDA MedWatch program using the information in the "Contact FDA" box at the bottom of this page.
FDA仍然认为此类药物对心血管是有好处的，但基于糖尿病的风险增加和记忆（大家应该知道老年痴呆症最大的问题就是记忆）的问题增加，临床医生必须向长期服用此类药物的患者提出这些警告，而不应该鼓励患者在胆固醇已经水平正常的情况下继续服用或者本着扩大临床应用范围而拿来做中风的预防用药，这是患者的知情权。以上是我对angle的回应，也就是我在给angle的电邮中说的，如果胆固醇水平正常的话建议不要摄入立普妥的意思。欢迎angle回应。
