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July 2, 2005

FDA Safety Labeling Changes

The FDA has approved revisions to the labeling on three drugs, Ellence, Abilify, and Kaletra. Each of the three drugs is associated with an increased risk of certain conditions.

Ellence is linked with a "cumulative risk" of leukemia. "Secondary AML with or without a preleukemic phase has been reported in patients treated with anthracyclines and is more common after dose escalations, heavy pretreatment with cytotoxic agents, or when they are used in combination with DNA-damaging antineoplastic agents. The leukemias can have a short one- to three-year latency period" (Waknine).

Abilify is associated with an increased risk of stroke in elderly patients who have dementia. "Results of three placebo-controlled clinical studies (one fixed-dose and two flexible-dose studies) showed that aripiprazole was associated with an increased incidence of cerebrovascular adverse events (eg, stroke, transient ischemic attack), including fatalities, in elderly patients (mean age, 84 years; range, 78 - 88 years) with dementia-related psychosis" (Waknine). Ironically, Abilify is not approved for treating "dementia-related psychosis. It is approved for treating schizophrenia and bipolar disorder.

The FDA warned against using Kaletra at the same time that one is using fluticasone propionate. "Results of a drug interaction study in healthy adults have shown that the ritonavir component of the combination drug significantly increases plasma fluticasone propionate exposures, resulting in significantly decreased serum cortisol concentrations. In addition, the FDA has received postmarketing reports of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression, in patients receiving ritonavir and inhaled or intranasally administered fluticasone propionate" (Waknine). It is recommended that the coadministration of these two drugs should only be used when the benefits to the patient outweigh the risk of systemic corticosteroid adverse effects.

The source of this article is Medscape, the homepage is at:

The article can be found at Although you do have to create a free account at Medscape to view the article.


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