2 ** ** * ** ** 1 50 -10 * -15 * -9 +15 * +17 ** (NS) 1 100 -18 ** -19 ** -13 * +24 +23 ** *** 1 150 -26 -24 -21 +31 +26 *** *** *** *** *** 2 50 -16 ** -19 ** -14 * +18 ** +21 *** 2 100 -23 -21 -17 ** +24 +24 *** *** *** *** 2 150 -31 -27 -24 +32 +29 *** *** *** *** *** Gemfibrozil
50 -38 -36 -34 +42 +41 (reference) *** *** *** *** *** Values are shown as mean [+ or -] SD of six animals (n = 6).
Although the reason for the increased rate of adverse effects with combination therapy is not clear, one possible explanation is that gemfibrozil
increases serum concentrations of active statin acids.
There is evidence, however, that the contraindication with gemfibrozil
, once it was discovered, was not effectively communicated to prescribing physicians, if at all (16).
According to the FDA, "Fatal rhabdomyolysis reports with Baycol have been reported most frequently when used at higher doses, when used in elderly patients, and particularly when used in combination with gemfibrozil
(Lopid and generics).
Doriott, who also used gemfibrozil
, said Tuesday that his symptoms came on rapidly two weeks after he began taking Baycol.
The company said it will not recall Baycol in Japan because gemfibrozil
is not an approved drug in Japan.
A spokesman for pharmaceutical firm Bayer plc said Cerivastatin, also known as Lipobay, had been withdrawn after reports that it could cause muscle breakdown when used in conjunction with gemfibrozil
, another drug used to lower cholesterol.
His regular medications included meclizine and aspirin; he also reported taking gemfibrozil
and pravastatin, but not on a consistent basis.
Specifically, the researchers found that high doses of the most widely prescribed of those drugs - the "statins" like Mevacor and Zocor, and the "fibrates" like Gemfibrozil
and Lopid - did invariably cause malignant tumors in the test animals.
Now two new developments are making it even more critical that someone investigate niacin: With health-care costs rising and coverage by private insurers (and possibly Medicare) shrinking, a cheap drug like niacin looks increasingly more attractive than costly cholesterol-lowering drugs like lovastatin or gemfibrozil
itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, and nefazodone); with gemfibrozil
, cyclosporine, or danazol; by anyone with active liver disease, unexplained persistent elevations of serum transaminases, or hypersensitivity to the product; or by women who are of childbearing age (unless highly unlikely to conceive), are nursing or who are pregnant.
was the fibrate used, and the statins in use were atorvastatin, simvastatin, and pravastatin.
After a few days of hospitalization, he recovered dramatically and was sent home on a treatment regime of gemfibrozil
, insulin and oral hypoglycemic agents.
1,200 mg/day of gemfibrozil
led to an absolute risk reduction of 10% in men with the "low HDL, low LDL" syndrome common in patients with type 2 diabetes.
6 mg/day) plus gemfibrozil
(600 mg twice a day) (8).