Food and Drug Administration Update for Pediatric Practitioners

Marcia L. Buck, Pharm.D., FCCP


Pediatr Pharm. 2002;8(1) 

In This Article

Adverse Effect Warnings

While the association between benzyl alcohol and gasping syndrome (cardiopulmonary collapse) in neonates is well known by most practitioners, the potential risk for using products containing this preservative can sometimes be overlooked. The product labeling for doxapram (Dopram®; Wyeth Ayerst) has recently been revised to highlight this risk in the neonatal population, where the drug is used for severe apnea. In addition, more detailed information on adverse effects in the neonatal population has been included.[11]

On December 4, 2001, Akorn Pharmaceuticals sent a letter to health care professionals notifying them of changes in the labeling of droperidol (Inapsine®). In conjunction with the FDA, the manufacturer has added a "black box" warning calling attention to the risk of arrhythmias with droperidol use. The drug had previously carried a warning about the risk of sudden cardiac death with high-dose therapy, but will now have labeling to warn of arrhythmias, including QT interval prolongation resulting in torsades de pointes, following doses within, or even below, the standard dosing range. The manufacturer now recommends an electrocardiogram (ECG) prior to initiating therapy in all patients. If the QT interval is prolonged and therapy is still considered necessary, ECG monitoring should be continued for the first 2 to 3 hours of treatment. The maximum recommended dose in children is now listed as 0.1 mg/kg.[12]

Centocor, Inc., the manufacturer of infliximab (Remicade®) has recently distributed "Dear Health Care Professional" letters regarding a worsening of symptoms in patients with congestive heart failure (CHF) who received infliximab for Crohn's disease.[13] The manufacturer, in conjunction with the FDA, recommends that the drug not be used in patients with CHF and that therapy be discontinued in patients receiving chronic therapy if their CHF worsens. This information follows another recent change in Remicade® labeling to highlight the risk of serious infection, including tuberculosis, during treatment.[14] Information on the use of infliximab in children can be found in Pediatric Pharmacotherapy 1999;5(11):1-4.

Topiramate (Topamax®; Ortho-McNeil) has become one of the most frequently used newer anticonvulsants on the U.S. market. It is indicated as adjunctive therapy for partial onset and primary generalized tonic-clonic seizures in patients 2 years of age or greater (Pediatric Pharmacotherapy 2001;7(6):1-4). In September 2001, topiramate received an additional indication as add-on therapy for patients with Lennox-Gastaut syndrome. With its increased use has come more information on its adverse effect profile. Based on post-marketing surveillance, product labeling for topiramate was revised on August 28, 2001 to highlight an association with an ocular syndrome characterized by acute myopia and secondary angle closure glaucoma. This can occur in pediatric patients as well as adults. Patients should seek immediate medical attention if they experience blurred vision or periorbital pain. The manufacturer recommends discontinuation of therapy as rapidly as possible.[15]


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