Merck responds to FDA warning of simvastatin use
WHITEHOUSE STATION, N.J. Merck & Co. has responded to a warning by the Food and Drug Administration about potential safety risks in patients taking the highest dose of a drug used to lower cholesterol.
“Simvastatin, when used as a supplement to a healthy diet, can help reduce LDL cholesterol and reduce the risk of death form cardiovascular disease in patients at high risk of coronary events,” Merck chief medical officer Michael Rosenblatt said in a statement. “We support the FDA’s recommendation that patients continue their medication as prescribed by their physicians and that patients speak to their physician if they have symptoms or questions.”
The FDA warned patients and healthcare professionals Friday of the risk of muscle injury, also known as myopathy, in patients taking simvastatin in the 80-mg strength. Though muscle injury is a side effect common among all statins, the agency said patients taking higher doses of simvastatin run a higher risk. Of particular concern is the risk of rhabdomyolysis, a severe form of myopathy that can lead to kidney damage, kidney failure and sometimes death.
Merck originally marketed the drug under the brand name Zocor, though it now is available as a generic and is included as an active ingredient in several drugs, including Merck’s Vytorin (ezetimibe and simvastatin) and Simcor (niacin and simvastatin), marketed by Abbott and Solvay Pharmaceuticals. Vytorin is available with 80 mg of simvastatin, though Simcor is only available with 20 mg.
Retail Clinician special report focuses on patient-centered care
NEW YORK Drug Store News’ sister publication, Retail Clinician, has issued a special report on an exclusive study conducted by Take Care Health Systems in conjunction with Gallup Consulting that measured patient engagement levels among Take Care Clinic visitors, with an eye toward elevating the patient experience.
The report, which is anchored by the original white paper — written by Sharon Glave Frazee, Ph.D., VP corporate healthcare analytics and research team for Walgreens, along with John H. Fleming, Ph.D., principal, chief scientist customer engagement and humansigma®, Gallup, and Margaret Ozan Rafferty, R.N., M.H.A., M.B.A., healthcare global practice leader for Gallup — and also includes an interview with Take Care CEO Peter Miller discussing the significance of the findings and what it means both for Walgreens and Take Care, and the impact Take Care’s unusually high levels of patient engagement is having on clinic traffic.
A copy of the report can be downloaded here.
High doses of cholesterol drug may raise muscle injury risk, FDA warns
SILVER SPRING, Md. Patients taking a common drug for treating high cholesterol may be at increased risk of muscle injury, the Food and Drug Administration warned Friday.
The FDA warned patients and healthcare professionals of the risk of muscle injury, also known as myopathy, in patients taking simvastatin in the 80-mg strength. Though muscle injury is a side effect common among all statins, the agency said patients taking higher doses of simvastatin run a higher risk. Of particular concern is the risk of rhabdomyolysis, a severe form of myopathy that can lead to kidney damage, kidney failure and sometimes death.
Merck originally marketed simvastatin under the brand name Zocor, and it is now available as a generic from several suppliers. It’s also an active ingredient in several other cholesterol-lowering drugs, including the Merck’s Vytorin (ezetimibe and simvastatin) and Simcor (niacin and simvastatin), marketed by Abbott and Solvay Pharmaceuticals. All formulations of Simcor contain only 20 mg of simvastatin, though Vytorin is available with 80 mg, according to an FDA database.
“Review of simvastatin is part of an ongoing FDA effort to evaluate the risk of statin-associated muscle injury and to provide that information to the public as it becomes available,” FDA Division of Metabolism and Endocrinology Products deputy director Eric Colman said in a statement. “It’s important for patients and healthcare professionals to consider all the potential risks and known benefits of any drug before deciding on any one therapy or dose of therapy.”