FDA Restricts Use of Simvastatin 80 mg
By Michael O'Riordan
The Food and Drug Administration is recommending that physicians restrict prescribing high-dose simvastatin (Zocor, Merck) to patients, given an increased risk of muscle damage. The new FDA drug safety communication, issued today, states that physicians should limit using the 80-mg dose unless the patient has already been taking the drug for 12 months and there is no evidence of myopathy.
"Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug," the agency states.
In addition, the FDA is requesting that additional changes be made to the drug's label. The label will be changed to include the new dosing recommendations, as well as warnings not to use the drug with various medications, including itraconazole (Sporanox, Jannsen Pharmaceutica), ketoconazole (Nizoral by Ortho-McNeil Pharmaceutical), posaconazole (Noxafil, Merck), erythromycin, clarithromycin, telithromycin (Ketek, Sanofi-Aventis), HIV protease inhibitors, nefazodone, gemfibrozil, cyclosporine, and danazol.
In addition, the 10-mg dose should not be exceeded in patients taking amiodarone, verapamil, and diltiazem, and the 20-mg dose should not be exceeded with amlodipine (Norvasc, Pfizer) and ranolazine (Ranexa, Gilead).
The changes to the label are based on the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH), a study reported by heartwire . In that trial, 52 patients taking the 80-mg dose developed myopathy compared with one patient treated with the 20-mg dose. In addition, 22 patients treated with the high dose of simvastatin developed rhabdomyolysis compared with none treated with the 20-mg dose.
The FDA notes that the risks of myopathy and rhabdomyolysis were highest in the first year and that older age and female sex increased the risks.
In statement released today following the FDA alert [2], Merck notes that it has launched a new information website and is encouraging patients who think the prescribing changes might affect them to speak with their doctors.
Dr Steven Nissen (Cleveland Clinic, OH), who wrote an editorial accompanying the 2004 publication of the A to Z trial, a study that tested high-dose simvastatin in acute coronary syndrome patients, who was critical of the high rate of myopathy in that study, called the FDA decision "appropriate" but said it comes late.
"Most knowledgeable lipid experts stopped administering the 80-mg dosage of simvastatin years ago," he said in an email to heartwire . "Unfortunately, once again the FDA has been too slow to react to a serious drug safety problem. We currently have more than two million Americans taking an unsafe dosage of simvastatin when there are safer alternatives. I'm glad the FDA acted but wish they hadn't taken so long."
Chocolate Intake Benefits the Heart and Brain
by Michael O'Riordan
Clinical Context
According to Ogbera in the January 12, 2010, issue of Diabetology & Metabolic Syndrome, approximately one fifth of adults worldwide are likely to have metabolic syndrome, a set of factors linked with a greater risk for type 2 diabetes and cardiovascular disease. The consumption of chocolate might be beneficial in the prevention of cardiometabolic disorders. A study by Allen and colleagues in the April 2008 issue of the Journal of Nutrition found that daily chocolate consumption had a positive effect on cardiovascular risk factors.
This meta-analysis by Buitrago-Lopez and colleagues assesses the association between chocolate intake and the risk for cardiometabolic disorders overall, in addition to the risk for cardiovascular disease, diabetes, stroke, and heart failure.
Clinical Implications
* Higher chocolate intake is related to a decreased risk for cardiometabolic disorders overall in 5 of 7 studies.
* Higher chocolate intake is related to a reduced risk for cardiovascular disease by 37%, diabetes by 31%, and stroke by 29%. There is no link between chocolate intake and heart failure.
The Story of Januvia
Two Merck research scientists, Nancy A. Thornberry and Ann E. Weber, Ph.D. received the 2011 Discoverers Award, the highest honor from the Pharmaceutical Research and Manufacturers of America (PhRMA), for their leadership in the discovery of JANUVIAŽ (sitagliptin), a once-daily pill that helps patients with type 2 diabetes control glucose in conjunction with diet and exercise. Weber and Thornberry are the first two women in Merck's 120-year history to lead the team that discovered a new medicine. And for the first time in the Discoverers Award's 24-year history, women alone were honored for their special achievements of exceptional benefit to humankind.
When JANUVIA was approved, it was the first new oral medication for diabetes in more than a decade, and the first medicine approved by the FDA to inhibit the enzyme DPP-4. By inhibiting DPP-4, JANUVIA helps prevent the degrading of a natural hormone that signals the pancreas to release insulin. Today, JANUVIA is being prescribed to millions of patients with type 2 diabetes and demonstrates Merck's commitment to develop therapies to improve human health around the world.
 
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FDA Restricts Use of Simvastatin 80 mg
Chocolate Intake Benefits the Heart and Brain
The Story of Januvia
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