American Psychiatric Association

July 19, 2018 | Editorial Board | View Online | Psychiatric News

In This Issue

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INDUSTRY BRIEFS

Lamotrigine Label Updated to Warn of HLH Risk

The FDA has required a new addition to the label of all formulations of Lamictal (lamotrigine) to warn about the risk of hemophagocytic lymphohistiocytosis (HLH). HLH can cause severe systemic inflammation and result in hospitalization or even death, especially if not recognized and treated early. The label notes that HLH symptoms have been reported to occur within 8 to 24 days following the initiation of treatment.

“Patients who develop early manifestations of pathologic immune activation should be evaluated immediately, and a diagnosis of HLH should be considered,” the label now states. “Lamictal should be discontinued if an alternative etiology for the signs or symptoms cannot be established.”

FDA Panel Rejects Abuse-Deterrent Oxycodone Formulation

Participants in a joint meeting of FDA's Anesthetic and Analgesic Drug Products Advisory Committee and its Drug Safety and Risk Management Advisory Committee last month voted 14-3 not to recommend the approval of Remoxy ER (oxydone extended-release capsules) for the management of severe pain.

Remoxy ER, made by Pain Therapeutics Inc., is a high-viscosity gel formulation designed to keep people from being able to cut, grate, or inject the drug. Some committee members suggested that data presented on the efficacy, safety, and risk-benefit profile of Remoxy ER did not support approval of its application, especially regarding claims of abuse deterrence.

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TEST YOUR KNOWLEDGE

Which of the following statements about cardiovascular side effects of antipsychotics in pediatric populations is true?

A. Thioridazine carries less risk of QTc prolongation and sudden death than do other typical antipsychotics.

B. Haloperidol has been associated with torsades de pointes.

C. An electrocardiogram (ECG) must be performed in any child who may be treated with atypical antipsychotics.

D. Ziprasidone is the safest of the atypical antipsychotics in terms of QTc prolongation.

E. Cardiovascular side effects of antipsychotics are not seen in children.

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