CholesterolÂlowering agents classified as statins (lovastatin and simvastatin, for example) should not be taken with certain supplements because of a risk of serious interactions.
The labels for simvastatin, Vytorin, and Simcor were also revised to include new dosing recommendations when these drugs are used with certain medicines that interact with simvastatin to increase the level of simvastatin in the body. At the end of the trial, the incidence of major vascular events was 25.7% in the 20-mg group versus 24.5% in the 80-mg group [RR=0.094, 95% CI (0.88, 1.01); p=0.10]. Twenty-two patients (0.4%) in the 80-mg group versus no patient in the 20-mg group developed rhabdomyolysis (defined as unexplained muscle weakness or pain with serum CK >40 times ULN). An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does.
This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.Things to remember when you fill your prescription.WebMD does not provide medical advice, diagnosis or treatment. Increasing the levels of simvastatin in the body can increase the risk for myopathy (see In March 2010, FDA announced it was reviewing the safety of simvastatin in the Agency's Patients currently taking 80-mg simvastatin-containing medicines should:FDA recommends that healthcare professionals should:The new changes to the drug labels for simvastatin-containing medicines are based on FDA's review of the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial and other data described in the Agency's March 2010 SEARCH was a seven-year, randomized, double-blind clinical trial comparing the efficacy and safety of simvastatin 80 mg to simvastatin 20 mg, with or without vitamin B12 and folate, in survivors of myocardial infarction. Nonetheless, the 6% reduction in relative risk for major vascular events observed in SEARCH is consistent with the 13 mg/dL lower level of LDL-C in the 80-mg group. A year after the release of new guidelines for treating high cholesterol, doctors and patients are still confused about just who needs to take statin drugs. Consult your healthcare professional (e.g., doctor or pharmacist) for more in formation.These medications may cause some risk when taken together. Approximately 60% of the cases of myopathy were associated with a genetic variant which affects the coding of the transporter responsible for simvastatin uptake into the liver. The risks for myopathy and rhabdomyolysis with simvastatin 80 mg were highest in the first 12 months of treatment, 5 per 1000 person-years and 2 per 1000 person-years, respectively, and decreased to 1 per 1000 person-years and 0.4 per 1000 person-years after that. Therapy usually is initiated with 10 or 20 mg daily, but individuals who have a high risk of heart disease can be started on 40 mg daily. If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with Vytorin (ezetimibe and simvastatin), like certain drugs that are used for HIV, infections, or depression. Patients with myopathy generally have muscle pain, tenderness or weakness, and an elevation of a muscle enzyme in the blood (creatine kinase, or CK). This information has been updated in the December 15, 2011, FDA Drug Safety Communication:
)Atorva=Atorvastatin; Fluva=Fluvastatin; Pitava=Pitavastatin; Lova=Lovastatin; Prava=Pravastatin; Rosuva=Rosuvastatin; Simva=Simvastatin. These medications are not usually taken together. Taking no more than the recommended dose of simvastatin with these medications will help keep simvastatin levels in the body at a safer level. There are many drugs that must not be taken with Vytorin (ezetimibe and simvastatin). 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. Rhabdomyolysis is rare; hospitalized rhabdomyolysis occurs in 4.9 people out of every 100,000 people exposed to simvastatin for one full year (the average incidence for hospitalized rhabdomyolysis for atorvastatin, pravastatin, or simvastatin is 4.4 people out of every 100,000 people exposed to the drugs for one full year).FDA has revised the drug labels for simvastatin and Vytorin to include the new dosing restriction for the 80-mg dose. Upsides. Severe Interactions.