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FDA revises labels, recommends limiting simvastatin dosing
FDA announced changes to safety labels for simvastatin, Vytorin, and Simcor, including dosing recommendations and is advising physicians to limit the use of 80-mg simvastatin due to an increased risk of myopathy.
Physicians should limit the use of 80-mg simvastatin due to an increased risk of myopathy, according to an FDA consumer update and a corresponding news release. The agency also announced changes to safety labels for simvastatin, Vytorin, and Simcor to include dosing recommendations when these drugs are used with medicines that can increase the level of simvastatin in the body.
The FDA recommendation follows a review of the results of the 7-year Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine clinical trial, other clinical trial data, and an analysis of data from the agency’s Adverse Event Reporting System, the statements say.
The 80-mg dose is the highest approved dose for lowering cholesterol in patients; but FDA recommends this dose should only be used if a patient has taken the 80-mg dose for 12 months or longer with no adverse effects. If physicians find that 40 mg of simvastatin isn’t helping patients lower their cholesterol levels, FDA advises trying another statin rather than raising the dose to 80 mg, Amy Egan, MD, deputy director for safety in the FDA division said in the consumer update.
“The FDA has completed its review of the safety of high-dose simvastatin and is making label changes to reduce the risk of statin-associated muscle injury,” said Eric Colman, MD, deputy director of the Division of Metabolism and Endocrinology Products in FDA’s Center for Drug Evaluation and Research. “We want to ensure that patients and healthcare professionals are aware of the new labeling changes to simvastatin, including the increased risk of myopathy when using the 80-mg dose of simvastatin,” he said in the agency’s news release.
Simvastatin is sold under the brand-name Zocor and as a single-ingredient generic product. It is also sold in combination with ezetimibe as Vytorin and in combination with niacin as Simcor.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
