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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

New FDA Approved Labeling For Vytorin (ezetimibe/simvastatin) Includes Results From the Study of Heart and Renal Protection (SHARP) in Patients With Moderate to Severe Chronic Kidney Disease

Posted 25 Jan 2012 by Drugs.com

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Jan 25, 2012 - Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved an updated label for Vytorin (ezetimibe/simvastatin) that includes results from the Study of Heart and Renal Protection (SHARP). In SHARP, Vytorin 10/20 mg lowered LDL cholesterol in patients with moderate to severe chronic kidney disease (CKD), and major vascular events were reduced in the treatment group compared to placebo. The trial therefore demonstrated that treatment with Vytorin 10/20 mg versus placebo reduced the risk for major vascular events in this CKD population. Because SHARP studied the combination of simvastatin and ezetimibe compared with placebo, it was not designed to assess the independent contributions of each drug to the observed effect; for this reason, the FDA ... Read more

Related support groups: Vytorin, Ezetimibe/Simvastatin

FDA Medwatch Alert: Zocor (simvastatin): Label Change - New Restrictions, Contraindications, and Dose Limitations

Posted 19 Dec 2011 by Drugs.com

Simvastatin sold under the brand-name Zocor, as a single-ingredient generic product, and sold in combination with ezetimibe as Vytorin and in combination with niacin as Simcor [UPDATED 12/15/2011] FDA notified the public that it has revised the dose limitation for simvastatin from 10 mg to 20 mg when it is co-administered with the cardiac drug amiodarone. The simvastatin drug labels (Zocor and generics, Vytorin) have been updated to reflect this correction. [Posted 06/08/2011] ISSUE: FDA notified healthcare professionals that it is recommending limiting the use of the highest approved dose of the cholesterol-lowering medication simvastatin (80 mg) because of increased risk of muscle damage. Patients taking simvastatin 80 mg daily have an increased risk of myopathy compared to patients taking lower doses of this drug or other drugs in the same class. This risk appears to be higher ... Read more

Vytorin Lowers Heart Disease Risk in Large Study of Kidney Patients

Posted 9 Jun 2011 by Drugs.com

THURSDAY, June 9 – The cholesterol-lowering drug Vytorin reduced the risk of heart disease among kidney patients by as much as 25 percent, according to the results of the largest kidney disease trial ever conducted. "People with kidney disease are at a high risk of heart attack and strokes," explained study author Dr. Colin Baigent, a professor of epidemiology at the University of Oxford in the U.K. "But there are very few studies attempting to see how that risk can be reduced. In healthy people we know that lowering LDL, or 'bad,' cholesterol reduces the risk. But now this is the first study to show that lowering LDL among people with kidney disease reduces risk as well." Baigent and his colleagues report on their research, which was funded in part by Vytorin maker Merck/Schering-Plough Pharmaceuticals, in the June 9 online issue of The Lancet. The findings were to be presented this ... Read more

Related support groups: Vytorin

FDA Medwatch Alert: Zocor (simvastatin): Label Change - New Restrictions, Contraindications, and Dose Limitations

Posted 9 Jun 2011 by Drugs.com

Simvastatin sold under the brand-name Zocor, as a single-ingredient generic product, and sold in combination with ezetimibe as Vytorin and in combination with niacin as Simcor [Posted 06/08/2011] ISSUE: FDA notified healthcare professionals that it is recommending limiting the use of the highest approved dose of the cholesterol-lowering medication simvastatin (80 mg) because of increased risk of muscle damage. Patients taking simvastatin 80 mg daily have an increased risk of myopathy compared to patients taking lower doses of this drug or other drugs in the same class. This risk appears to be higher during the first year of treatment, is often the result of interactions with certain medicines, and is frequently associated with a genetic predisposition toward simvastatin-related myopathy. The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney ... Read more

Related support groups: Simvastatin, Zocor, Vytorin, Simcor, Niacin/Simvastatin, Ezetimibe/Simvastatin

Drugs.com Refutes Erroneous Claims

Posted 13 Nov 2009 by Drugs.com

This week in Washington, D.C. saw the public hearings on promotion of FDA-regulated medical products using the internet and social media tools. Drugs.com got a mention and a reference or two by one of the speakers. People heard, wrote, tweeted, blogged, reported and within minutes the quote had gone viral on the internet. The problem is, what got reported wasn't entirely true. Press releases were issued that spoke of "user-edited content on sites such as Drugs.com" and "inaccurate or incomplete information", "misinformation or unbalanced information," and "lack of consistency about the quality of information on websites like Wikipedia and Drugs.com." Firstly, to set the record straight, there is no user-edited content on Drugs.com. Period. Our content is derived from a number of well-respected medical publishers including Cerner Multum, Thomson Reuters - Micromedex, Physicians’ D ... Read more

Related support groups: Vytorin

FDA Backs Cholesterol Drug Vytorin

Posted 8 Jan 2009 by Drugs.com

THURSDAY, Jan. 8 – After nearly a year of review, U.S. health officials said Thursday that they supported the continued use of the controversial cholesterol-lowering drug Vytorin. The U.S. Food and Drug Administration said there was no significant difference in carotid artery thickness between patients taking Vytorin and patients taking the drug Zocor. But, the agency reported, the levels of LDL (bad) cholesterol decreased by 56 percent in the Vytorin group compared to 39 percent for the Zocor group. The debate over Vytorin began early last year when preliminary results of the so-called Enhance trial showed that the drug had little benefit. A study released Jan. 14, 2008, by Vytorin's makers found that the drug – a combination of Zocor (simvastatin) and Zetia (ezetimibe) – might not be any more effective at reducing the build-up of plaque in the arteries than Zocor alone. In a ... Read more

Related support groups: Vytorin

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, Altocor, Pravigard Pac

No Definitive Link Seen Between Vytorin and Cancer

Posted 2 Sep 2008 by Drugs.com

TUESDAY, Sept. 2 – New research finds no definitive link between Vytorin and cancer risk, but it also suggests that the cholesterol-lowering drug cannot curb cardiovascular disease. The results of a small study published recently suggested that Vytorin (ezetimibe) might boost the chances of developing cancer. In that study, called SEAS, researchers found that among patients taking Vytorin, 101 developed cancer, compared with 65 in the control group. Among these patients, 39 taking Vytorin died, compared with 23 in the control group. However, a three-study analysis in the Sept. 2 issue of the New England Journal of Medicine did not find compelling evidence of such a connection. A second study in the same issue of the journal found that taking Vytorin with a statin did not benefit patients with abnormal narrowing of the aortic valve called aortic stenosis. "Overall, the three ezetimibe ... Read more

Related support groups: Vytorin

FDA Investigates Possible Vytorin-Cancer Link

Posted 21 Aug 2008 by Drugs.com

THURSDAY, Aug. 21 – U.S. drug regulators said Thursday that they were investigating whether the cholesterol-lowering drug Vytorin might be linked to cancer. The U.S. Food and Drug Administration said it has informed health-care professionals that the agency was investigating a report from the so-called Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial of a possible association between the use of Vytorin and an increased risk of a variety of cancers. Vytorin is a combination drug made up of the compounds simvastatin and ezetimibe that's designed to reduce levels of LDL (bad) cholesterol and cut the risk of cardiovascular problems. It works by decreasing the production of cholesterol by the liver and inhibiting the absorption of cholesterol in the intestine. In a statement released Thursday afternoon, the FDA said it had obtained preliminary results from the SEAS trial. The trial ... Read more

Related support groups: Vytorin

FDA Medwatch Alert: Ezetimibe/Simvastatin (Vytorin); Simvastatin (Zocor); and Ezetimibe (Zetia)

Posted 21 Aug 2008 by Drugs.com

[Posted 08/21/2008] FDA informed healthcare professionals that the Agency is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial of a possible association between the use of Vytorin and a potentially increased incidence of cancer. Vytorin is a combination product of simvastatin and ezetimibe used to decrease the production of cholesterol by the liver and inhibit the absorption of cholesterol in the intestine to reduce LDL-cholesterol levels and reduce the risk of cardiovascular events. Recently, FDA obtained preliminary results from the SEAS trial. The clinical trial tested whether lowering LDL-cholesterol with Vytorin would reduce the risk of cardiovascular events in individuals with aortic stenosis. A lower overall cardiovascular risk was not found with Vytorin. However, there was an additional observation that a larger percentage of subjects ... Read more

Related support groups: Zocor, Vytorin, Zetia

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

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