"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
Dotarem is a gadolinium-based"...
Clinical Trials Experience
Phlebitis with or without leucocytosis and with or without mild pyrexia has occurred after administration of hematin through small arm veins.
Reversible renal shutdown has occurred with administration of excessive doses (See “PRECAUTIONS” section).
There have been post-marketing literature reports of thrombocytopenia and coagulopathy (including prolonged prothrombin time and prolonged partial thromboplastin time) in patients receiving PANHEMATIN.8 Iron overload and serum ferritin increased have also been reported (See “PRECAUTIONS” section).
To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Read the Panhematin (hemin) Side Effects Center for a complete guide to possible side effects
No information provided.
8. Morris, D.L., et al., Coagulopathy Associated with Hematin Treatment for Acute Intermittent Porphyria, Ann Intern Med 95:700-701, 1981.
Last reviewed on RxList: 9/18/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Panhematin 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.