"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"...
Burning or cramping sensations indicate local reactions. Urticaria may result. Sloughing and necrosis of tissue may occur with extravasation of the drug. Technique development is essential for optimal success in sclerotherapy, therefore the drug should be administered only by a physician familiar with proper injection technique. Drowsiness and headache may occur rarely. Pulmonary embolism has been reported.
Rarely, patients may have, or may develop hypersensitivity to Morrhuate Sodium, characterized by dizziness, weakness, vascular collapse, asthma, respiratory depression, gastrointestinal disturbances (i.e., nausea, vomiting), and urticaria. Anaphylactic reactions may occur within a few minutes after injection of the drug and are most likely to occur when therapy is reinstituted after an interval of several weeks. Morrhuate Sodium (morrhuate sodium injection) should only be administered when adequate facilities, drugs (i.e., epinephrine, antihistamines, corticosteroids), and personnel are available for the treatment of anaphylactic reactions.
Pregnancy Category C: Animal reproduction studies have not been performed. It is not known whether Morrhuate Sodium (morrhuate sodium injection) Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Use of Morrhuate Sodium (morrhuate sodium injection) in women of childbearing potential requires that anticipated benefits be weighed against the possible hazards.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Morrhuate Sodium Information
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