"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"...
Patients receiving OMNISCAN should be instructed to inform their physician if they:
- are pregnant or breast feeding, or
- have a history of renal and/or liver disease,
convulsions, asthma or allergic respiratory disorders, or recent administration
of gadolinium-based contrast. GBCAs increase the risk for NSF among patients with
impaired elimination of the drugs. To counsel patients at risk for NSF:
- Describe the clinical manifestations of NSF
- Describe procedures to screen for the detection of renal impairment
Instruct the patients to contact their physician if they develop signs or symptoms of NSF following OMNISCAN administration such as burning, itching, swelling, scaling, hardening and tightening of the skin; red or dark patches on the skin; stiffness in joints with trouble moving, bending or straightening the arms, hands, legs or feet; pain deep in the hip bones or ribs; or muscle weakness.
Last reviewed on RxList: 12/5/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Omniscan Information
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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.
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