Pancreatitis & Valproate
The American Food and Drug Administration and Abbott Laboratories has sent a letter to physicians in the USA to describe changes in the official prescribing information for divalproex sodium (Epival®) and valproic acid (Depakene®).
The letter advises people taking these medications to contact their doctor promptly if they experience any abdominal pain, nausea, vomiting, and/or anorexia. Such symptoms could be signs of pancreatitis, a rare but potentially life-threatening side effect.
Pancreatitis (inflammation of the pancreas) has been identified in American documentation as a possible effect of these drugs since 1981. The Canadian Compendium of Pharmaceuticals and Specialties simply notes that there have been reports of acute pancreatitis, including rare fatal cases, occurring in association with valprate therapy.
Changes in American documentation give this potential reaction new visibility by placing a description of the condition, its symptoms, and risk in a warning box in the document and in the package insert.
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