Safety label changes approved by FDA

Label changes for statins, a type of cholesterol-lowering medication, have been approved by the Food and Drug Administration (FDA), USA. Labels will include more data on adverse events, drug interactions, and the checking of liver enzymes. The FDA says these changes will provide patients with more information so they can use statins more safely and effectively. Liver enzyme monitoring The need to routinely monitor liver enzymes among patients taking statins has been revised in the labeling. The updated information recommends testing for liver enzymes before beginning to take statins "and as clinically indicated thereafter". The FDA informs that serious liver injury caused by statins is very uncommon, and also hard to predict on a patient-to-patient bases. Periodically monitoring liver enzymes does not seem to impact on serious liver injury risk, nor does it effectively detect serious injury. Data regarding adverse events Data on statin usage and a link to memory loss, confusion (cognitive side effects) have been added to the labeling information. The FDA explains that these potential cognitive consequences are reversible. The updated label also informs about reports of elevated HbA1c (glycosylated hemoglobin) and blood sugar levels. However, the Agency emphasizes that the benefits offered by statins outweigh the slightly increased risks of these adverse events. Drug interactions Drug interaction refers to a physiological or chemical reaction that can occur when two different medications are taken at the same time. Put simply - how one drug can alter the effect of another drug; such as making its active ingredient much more powerful, less powerful/effective, or useless. The labeling of lovastatin includes data on new contraindications and dose limitations when it is taken in combination with other drugs - in some cases there might be a higher likelihood of muscle injury. When prescribing statins, doctors should refer to the drug labels, the FDA urges. Any concerns by patients regarding the usage of stating should be referred to their doctors What are statins? Statins are a class of drugs that lower cholesterol. The FDA adds that this occurs more effectively if combined with a healthy diet and exercise. Statins lower blood levels of LDL (low-density lipoprotein) cholesterol, also known as bad cholesterol. Statins are prescription medications and are marketed as single-ingredient or combination products. Examples of single-ingredient statins include: Altoprev (lovastatin extended-release) Crestor (rosuvastatin) Lescol (fluvastatin) Lipitor (atorvastatin) Livalo (pitavastatin) Pravachol (pravastatin) Mevacor (lovastatin) Zocor (simvastatin) Examples of statins as combination products include: Advicor (lovastatin/niacin extended-release) Simcor (simvastatin/niacin extended-release) Vytorin (simvastatin/ezetimibe)