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FDA Medwatch Alert: Statin Drugs - Drug Safety Communication: Class Labeling Change

Posted 29 Feb 2012 by Drugs.com

ISSUE: FDA has approved important safety label changes for the class of cholesterol-lowering drugs known as statins. The changes include removal of routine monitoring of liver enzymes from drug labels. Information about the potential for generally non-serious and reversible cognitive side effects and reports of increased blood sugar and glycosylated hemoglobin (HbA1c) levels has been added to the statin labels. The lovastatin label has been extensively updated with new contraindications and dose limitations when it is taken with certain medicines that can increase the risk for muscle injury. Read the FDA Drug Safety Communication for more information. BACKGROUND: Statins are 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 ... Read more

FDA Adds Safety Warnings to Statins

Posted 28 Feb 2012 by Drugs.com

TUESDAY, Feb. 28 – The popular cholesterol-lowering drugs called statins will now come with revised labels warning of a slight increased risk of elevated blood sugar levels, which could lead to type 2 diabetes, as well as a warning on rare cases of confusion and memory loss, U.S. drug regulators said Tuesday. But the U.S. Food and Drug Administration, which made the announcement, and health-care professionals all stressed that the heart-protective benefits of statins – which include drugs such as Crestor, Lipitor, Pravachol and Zocor – far outweigh the risks spelled out on the new labels. "We want health-care professionals and patients to have the most current information on the risks of statins, but also to assure them that these medications continue to provide an important health benefit of lowering cholesterol," Dr. Mary Parks, director of the FDA's Division of Metabolism and ... Read more

Statins Lower Blood Marker for Prostate Cancer

Posted 30 Oct 2008 by Drugs.com

THURSDAY, Oct. 30 – A new study shows that men who take cholesterol-lowering drugs called statins have lower blood levels of prostate-specific antigen (PSA), a biomarker for prostate cancer risk. That drop in PSA levels doesn't necessarily mean the drugs protect against disease however, researchers say. But it's possible that statins may offer some protection against the disease, said Dr. Robert Hamilton, one author of the report in the Oct. 28 issue of the Journal of the National Cancer Institute. He worked on the study while a research fellow at Duke University; he is now a urology resident at the University of Toronto. "The reduction in PSA was in proportion to the dose of statins that were taken and to the reduction of cholesterol levels," Hamilton said, indicators of a possible protective effect. The study was done because of "encouraging recent data" from four previous studies ... Read more

Related support groups: Lipitor, Crestor, Prostate Cancer, Zocor, Pravachol, Lescol, Advicor, Altocor

Statins Lower Risk of Clots in Cancer Patients

Posted 27 Oct 2008 by Drugs.com

MONDAY, Oct. 27 – A class of drugs widely used to lower cholesterol may have a future in preventing blood clots in patients with breast, lung, colon and other solid-organ cancers. Research from scientists at the Albert Einstein Medical Center in Philadelphia found that cancer patients taking statins had a lower incidence of clots than did patients not taking the medications. But experts cautioned that the results, which were expected to be presented at the American College of Chest Physicians' annual meeting in Philadelphia, are not yet ready for prime time. Even the researchers noted the preliminary nature of the findings. Study author Dr. Danai Khemasuwan called the discovery "thought-provoking," but added that randomized, controlled studies are needed before the results can be applied in the clinical arena. Experts agreed with that analysis. "This preliminary analysis is ... Read more

Related support groups: Lipitor, Crestor, Zocor, Pravachol, Lescol, Advicor, Altocor

FDA Medwatch Alert: Statin drugs and amyotrophic lateral sclerosis (ALS)

Posted 30 Sep 2008 by Drugs.com

[Posted 09/30/2008] An FDA analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." The FDA analysis, undertaken after the agency received a higher than expected number of reports of ALS in patients on statins, is based on data from 41 long-term controlled clinical trials. The results showed no increased incidence of the disease in patients treated with a statin compared with placebo.The FDA is anticipating the completion of a case-control or epidemiological study of ALS and statin use. Results from this study should be available within 6-9 months. FDA is also examining the feasibility of conducting additional epidemiologic studies to examine the incidence and clinical course of ALS in patients taking statins.Based on currently available information, ... Read more

Related support groups: Lipitor, Crestor, Zocor, Vytorin, Pravachol, Simcor, Caduet, Lescol, Advicor, Altocor, Pravigard Pac

Statins Can Hinder Muscle Repair

Posted 25 Sep 2008 by Drugs.com

THURSDAY, Sept. 25 – Statins, taken by millions to lower cholesterol, may hinder the body's ability to repair muscles, University of Alabama researchers report. The most frequently reported side effect of statin therapy is fatigue, with about 9 percent of patients reporting muscle pain. As doses of the medication are increased, and physical activity is added, these effects can be more pronounced. These side effects are found in all commonly used statins. "While these are preliminary data and more research is necessary, the results indicate serious adverse effects of statins that may alter the ability of skeletal muscle to repair and regenerate due to the anti-proliferative effects of statins," lead researcher Anna Thalacker-Mercer said in a statement. Results of the study were presented Thursday at a meeting of the American Physiological Society, in Hilton Head, S.C. For the study, ... Read more

Related support groups: Lipitor, Crestor, Zocor, Vytorin, Pravachol, Caduet, Lescol, Advicor, Pravigard Pac, Altocor

Cholesterol-Lowering Drugs Won't Cause Cancer

Posted 20 Aug 2008 by Drugs.com

WEDNESDAY, Aug. 20 – Researchers who last year reported a possible link between cholesterol-lowering statin drugs and cancer now say that further analysis has disproved such an association. Statin medications include such blockbusters as Crestor, Lipitor, Pravachol and Zocor. "The bottom line is that there is no evidence from this work, the largest study published to date, that the cholesterol-lowering ability of statins increases the risk of cancer," said Dr. Richard H. Karas, director of preventive cardiology at Tufts Medical Center and leader of a group reporting the finding in the Journal of the American College of Cardiology. A little more than a year ago, a report by Karas and his colleagues in the same journal described a slight increase in cancer risk among statin users – about one extra case per 1,000 people. That finding came from 13 trials that gathered information on side ... Read more

Related support groups: Lipitor, Crestor, Zocor, Vytorin, Pravachol, Simcor, Caduet, Lescol, Advicor, Altocor, Pravigard Pac

Statins Help Obese People After Bypass Surgery

Posted 15 Aug 2008 by Drugs.com

FRIDAY, Aug. 15 – Statins reduce the perils facing obese people after they have the bypass surgery that restores blood flow to an endangered heart, a study finds. The study was done to help settle a running controversy about the ill effects of obesity in such cases, said Dr. Christina C. Wee, an associate professor of medicine at Harvard Medical School, co-director of research in the division of general medicine at Beth Israel Deaconess Hospital and lead author of a report in the Aug. 19 issue of the Journal of the American College of Cardiology. "We know that obesity, per se, is a risk factor for developing heart disease," Wee said. "But once you develop it, is obesity more detrimental than not being overweight? There have been different studies with results going both ways." To settle the issue, Wee and her colleagues studied the outcome of bypass surgery for 1,314 people in a ... Read more

Related support groups: Obesity, Lipitor, Crestor, Zocor, Vytorin, Pravachol, Simcor, Caduet, Lescol, Advicor, Altocor, Pravigard Pac

Statins Might Reverse ED in Some Men

Posted 15 Aug 2008 by Drugs.com

FRIDAY, Aug. 15 – Statins might quickly help reverse erectile dysfunction among men who have metabolic syndrome, new animal research suggests. A threat to cardiovascular health, metabolic syndrome is also known to raise the risk for erectile dysfunction (ED). The current finding indicates that statins may reduce levels of a specific protein that contributes to ED. "Each condition of metabolic syndrome phenomenon – high blood pressure, type 2 diabetes and obesity – independently raises the risk for erectile dysfunction just on their own," explained study author Christopher J. Wingard, an associate professor of physiology with the Brody School of Medicine at East Carolina University in Greenville, N.C. "And so, when all are present in combination as part of this syndrome, you have a situation where you don't even need to be as diabetic or hypertensive as you might otherwise have to be ... Read more

Related support groups: Erectile Dysfunction, Lipitor, Crestor, Zocor, Vytorin, Pravachol, Simcor, Caduet, Lescol, Advicor, Pravigard Pac, Altocor

Cholesterol-Lowering Drugs Might Help Prevent Alzheimer's

Posted 28 Jul 2008 by Drugs.com

MONDAY, July 28 – Older people who were taking cholesterol-busting statin medications saw their risk for dementia fall by half, a new study found. The finding appears to be more evidence that statins – which include drugs such as Crestor, Lipitor, Pravachol and Zocor – can help maintain brain health. "This is another brick in the wall, in the sense that there is mounting evidence, primarily from observational studies, that there is at least some benefit for prevention of dementia," said lead researcher Mary N. Haan, professor of epidemiology at the University of Michigan School of Public Health. Her team published the findings in the July 29 issue of Neurology. The study involved almost 1,700 Mexican-Americans, aged 60 and older, who were followed for five years. The effort was aimed at people at high risk of developing dementia because of conditions such as high blood pressure, ... Read more

Related support groups: Lipitor, Crestor, Zocor, Vytorin, Pravachol, Simcor, Caduet, Lescol, Advicor, Pravigard Pac, Altocor

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High Cholesterol, Hyperlipoproteinemia, Hyperlipoproteinemia Type IIb (Elevated LDL + VLDL), Hyperlipoproteinemia Type IIa (Elevated LDL), High Cholesterol - Familial Heterozygous