The FDA has reported that 5106 elderly patients with dementia treated with atypical (second generation) antipsychotics in 17 randomized controlled trials had a higher mortality rate (4.5% vs. 2.6%) than those receiving placebo. Most of the deaths were due to cardiovascular and infectious causes (such as pneumonia). The drugs used in the trials were aripiprazole (Abilify), olanzapine (Zyprexa), quetiapine (Seroquel), and risperidone (Risperdal). As the increase in mortality was considered a class effect, the FDA advisory also included ziprasidone (Geodon), clozapine (Clozaril) and the...

Some Medical Letter consultants have suggested that our recent article on dermal fillers (Med Lett Drugs Ther 2007; 49:39) should have included stronger warnings about the risk of fillers that are not biodegradable, such as Artefill. The polymethylmethacrylate (PMMA, the same material that makes up Plexiglas) beads in Artefill can over time, even with the best technique, cause foreignbody granulomas and hypertrophic scarring, which may require surgical removal. Granulomas and nodules have been especially frequent when Artefill was injected into the lips. Complications are less likely with...

The anthracycline doxorubicin with or without the alkylating agent ifosfamide is the standard first-line treatment for advanced soft-tissue sarcomas. The FDA recently approved the minor groove DNA intercalator trabectedin (Yondelis – Janssen) for treatment of unresectable or metastatic liposarcoma or leiomyosarcoma in patients previously treated with an anthracycline. Trabectedin has been available for years in Europe for treatment of advanced soft-tissue sarcoma. The FDA has also approved the microtubule inhibitor eribulin mesylate (Halaven – Eisai), which was approved earlier for...

Ropinirole (Requip - GlaxoSmithKline), a dopamine agonist already available for treatment of Parkinson's disease, is now the first drug approved by the FDA for treatment of moderate to severe restless legs syndrome (RLS).

The FDA has approved the marketing of Resperate (InterCure), a device that helps patients breathe slowly, as an adjunct for treatment of hypertension. The FDA does not require proof of effectiveness for approval of devices with minimal potential for harm, such as this one.

Quantiferon - TB Gold (Cellestis) is a T-cell interferon-gamma release assay approved by the FDA as an alternative to the tuberculin skin test for diagnosis of infection with Mycobacterium tuberculosis (TB). An earlier assay (Quantiferon-TB), which is no longer commercially available, was approved by the FDA in 2001. Other interferon-gamma release assays (IGRAs) are available abroad.

Short-acting methylphenidate (MPH) is effective for treatment of attention-deficit/hyperactivity disorder (ADHD), but its 3-5 hour duration of action usually requires mid-day dosing in school, which children may find disruptive or stigmatizing.

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Use of a proton pump inhibitor (PPI) to protect against gastrointestinal (GI) bleeding in patients taking the antiplatelet agent clopidogrel (Plavix) may interfere with the activation of clopidogrel and diminish its antiplatelet effect, increasing the risk of cardiovascular events.1 A randomized, placebo-controlled trial (COGENT) has found that use of the PPI omeprazole in patients taking clopidogrel in addition to aspirin decreased the incidence of GI bleeding without increasing the risk of a cardiovascular event, but the number of cardiovascular events was small and the formulation of...

Ursodiol (ursodeoxycholic acid), a naturally occurring bile acid, will soon be marketed in the USA as (Ciba-Geigy), an oral drug for dissolution of gallbladder stones. The labeling for the drug, which has been available in other countries for the past ten years, will restrict its use to dissolution of radiolucent, noncalcified gallbladder stones less than 20 mm in diameter in patients who have refused or are at increased risk from surgery.