Asenapine (Saphris - Schering-Plough), a dibenzo-oxepino pyrrole, has been approved by the FDA in a sublingual tablet formulation for acute treatment of schizophrenia and manic or mixed episodes associated with bipolar disorder. It is the sixth second-generation antipsychotic approved by the FDA for use in bipolar disorder.

Warfarin sodium (Coumadin, and others) and other coumarin anticoagulants prevent thrombosis, but patient response is highly variable and overanticoagulation can lead to hemorrhage. Genotyping patients for single nucleotide polymorphisms (SNPs) that affect coumarin metabolism and sensitivity may help clinicians estimate the therapeutic warfarin dose. The FDA has added a note to warfarin labeling recommending lowrange doses for patients with such genetic variations. Commercial tests for these variants are now available and cost about $500 per test.

(Med Lett Drugs Ther 2008; 50:91) In the Clinical Studies section, the complete response rate with chlorambucil for CLL was 2% (not 24%).

Changes caused by one drug in the absorption, distribution, metabolism or excretion of another may lead to a pharmacokinetic adverse drug interaction (DN Juurlink et al, JAMA 2003; 289:1652). Additive drug interactions, such as vasodilation caused by both sildenafil (Viagra) and nitrates, can also have adverse effects.

Alprazolam, a short-acting benzodiazepine, is one of the most widely prescribed drugs in the US. It is approved by the FDA for treatment of anxiety and panic disorder. An extended-release formulation, Xanax XR, which can be taken once a day, recently became available for panic disorder.

A "Dear Colleague" letter from the UK's Committee on Safety of Medicines advised physicians, on the basis of unpublished data, not to use paroxetine (Paxil in the US; Seroxat in the UK) to treat children and adolescents with depression because of possible increased risk of suicidal behavior. This review describes the efficacy and safety of SSRIs in children.

Ramelteon (Rozerem - Takeda), a melatonin receptor agonist, has been approved by the FDA for treatment of insomnia characterized by difficulty falling asleep. Unlike all other prescription hypnotics, which are classified as schedule IV drugs, ramelteon is not a controlled substance.

A reader expressed disappointment that our recent listing of “Some Warfarin Drug Interactions”1 did not include acetaminophen. Perhaps it should have. Acetaminophen can increase the anticoagulant effect of warfarin, particularly with continued use, but it does so inconsistently. The mechanism of this interaction has not been established, but may be related to an acetaminophen metabolite inhibiting vitamin K-epoxide reductase, the target for warfarin’s anticoagulant effect.2Patient susceptibility varies, possibly on a genetic basis; occasional use of acetaminophen generally has little or...

The FDA has approved 2 oral drugs for treatment of idiopathic pulmonary fibrosis (IPF). Pirfenidone (Esbriet) has been available in Europe since 2011 and in Canada since 2012. Nintedanib (Ofev) is available only in the US.

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...