"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
(Generic versions may still be available.)
While there has been no reported case of overdosage, should it occur, symptomatic supportive measures should be taken.
Clofibrate is contraindicated in pregnant women. While teratogenic studies have not demonstrated any effect attributable to clofibrate, it is known that serum of the rabbit fetus accumulates a higher concentration of clofibrate than that found in maternal serum, and it is possible that the fetus may not have developed the enzyme system required for the excretion of clofibrate.
It is contraindicated in patients with clinically significant hepatic or renal dysfunction. Rhabdomyolysis and severe hyperkalemia have been reported in association with pre-existing renal insufficiency.
It is contraindicated in patients with primary biliary cirrhosis, since it may raise the already elevated cholesterol in these cases.
It is contraindicated in patients with a known hypersensitivity to clofibrate.
It is contraindicated in nursing women (see PRECAUTIONS ).
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Atromid-S Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.