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Psychopharmacology News

JOURNAL OF CHILD AND ADOLESCENT PSYCHOPHARMACOLOGYVolume 15, Number 4, 2005© Mary Ann Liebert, Inc.Pp. 527–528

IN THIS COLUMN, we will review two recentpharmacologic updates. The first of these up-

dates has to do with the GlaxoSmithKline, Inc.(GSK) product Paxil CR® (paroxetine). OnMarch 4, 2005, the U.S. Food and Drug Admin-istration (FDA) issued a health advisory ex-plaining that U.S. Marshals had seized lots ofthe product for violations of “Continuing GoodManufacturing Practice.” The seizures tookplace in the Puerto Rico manufacturing plant,as well as in distribution centers in Knoxville,Tennessee, and Puerto Rico. It was alleged thatthe manufacturer failed to meet FDA stan-dards with respect to strength, quality, and pu-rity. The FDA states that it is not aware of anyill effects or hazard posed by the pills. How-ever, the agency is concerned that the manu-facturing violation could potentially pose risksto patients who take the medication. Specifi-cally, the violations included that the Paxil CRtablets could “split apart,” and thus patientscould potentially take the portion of the pillwithout the active ingredient, or, conversely,they could be taking the portion of the pillwith the active ingredient but without the con-trolled-release effect. It should be noted thatGSK had voluntarily recalled some of the af-fected lots of Paxil CR, and the seizure was en-acted to ensure that all affected lots wereaccounted for.

The next update is about agents commonlyused in psychiatry, but not specifically for a find-ing related to the child age group. Nevertheless,the advisory, because of its potential implication,warrants that all psychiatrists be informed. OnApril 11, 2005, the FDA, in reviewing data on17 studies involving 5106 geriatric-aged demen-tia patients, determined that using the atypical

antipsychotics [olanzapine (Zyprexa®), arip-iprazole (Abilify®), risperidone (Risperdal®),or quetiapine (Seroquel®)] for behavioral dis-orders in this population was associated withan increased mortality risk. In fact, 15 of the 17studies demonstrated this increased risk. Thestudies were all placebo-controlled. In these stud-ies, the atypical antipsychotic agents were as-sociated with approximately a 1.6- to 1.7-foldincrease in mortality rates. It was reported thatthe majority of the deaths were related to car-diovascular causes, such as heart failure or sec-ondary to infections (primarily pneumonia).The FDA has asked the manufacturers of allatypical agents to include the boxed warningon their labeling, irrespective of their not beingsystematically studied for this indication, basedon their assumption that “the effect is proba-bly related to the common pharmacologic effectsof all atypical antipsychotic medications.” Theadvisory also stated that the FDA was consid-ering a similar warning to the labeling of thetypical antipsychotic agents as well.

We are also including an updated list of con-ferences for your consideration.

• The 57th Institute on Psychiatric Servicesmeeting will be held in San Diego, CA,October 5–9, 2005, contact 703-907-1090.

• The AACAP’s 52nd Annual Meeting willbe held in Toronto, Canada, October 18–23, 2005, contact 800-333-7636.

• The AACAP PsychopharmacologyUpdate Institute will be held in NewYork, NY, January 2006; contact 800-333-7636.

• The 159th Annual Meeting of the Ameri-can Psychiatric Association will be held in

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Toronto, Canada, May 20–25, 2006, con-tact 800-333-7636.

• The AACAP 31st Annual Review Coursewill be held in Cincinnati, OH, June 2006,contact 800-333-7636.

• The 58th Institute on Psychiatric Servicesmeeting will be held in New York, NY,October 5–8, 2006, contact 703-907-1090.

• The AACAP’s 53rd Annual Meeting willbe held in San Diego, CA, October 24–29,2006, contact 800-333-7636.

—Raul S. Silva, M.D.Associate Editor

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