The FDA has approved Cobenfy (BMS), an oral fixed-dose combination of the muscarinic agonist xanomeline and the peripheral muscarinic antagonist trospium chloride, for treatment of schizophrenia in adults. It is the first antipsychotic drug to be approved in the US for treatment of schizophrenia that does not block dopamine receptors. This is the first approval for xanomeline; trospium has been available for many years for treatment of overactive bladder.

Flurbiprofen (Ansaid - Upjohn), a nonsteroidal anti-inflammatory drug (NSAID) available in some countries since 1977, was recently approved by the US Food and Drug Administration for treatment of rheumatoid arthritis and osteoarthritis. Flurbiprofen is a fluorinated phenylalkanoic acid derivative structurally related to ibuprofen (Motrin;and others).

Tegaserod maleate (Zelnorm), a 5-HT4 receptor partial agonist that increases gastrointestinal (GI) motility, was approved by the FDA in 2002 for short-term treatment of irritable bowel syndrome with constipation (IBS-C) in women and in 2004 for treatment of chronic idiopathic constipation (CIC) in adults <65 years old.In 2007, the manufacturer (Novartis) complied with an FDA request to stop marketing the drug based on an unpublished retrospective analysis of clinical trials in IBS-C and other GI motility disorders that showed a higher rate of ischemic cardiovascular events (including...

Meloxicam, a nonsteroidal anti-inflammatory drug (NSAID) with some cyclooxygenase-2 (COX-2) selectivity in vitro, has been approved by the FDA for treatment of osteoarthritis.

Rofecoxib (Vioxx - Merck) has been withdrawn from the market due to an increased risk of cardiovascular complications associated with its long-term use. The question remains whether all selective COX-2 inhibitors carry the same risk. Full-page advertisements in newspapers for celecoxib (Celebrex - Pfizer), the most widely used COX-2 inhibitor, assure the public that it does not.

One of our readers has suggested that more attention should have been paid to a study comparing the antiplatelet effects of immediate-release and enteric-coated aspirin that appeared in Circulation last year.1 The safety benefits of enteric-coated aspirin are unclear. It may protect against dyspepsia, but not against major gastrointestinal bleeding, which is thought to be mainly a systemic effect of prostaglandin inhibition.ANTIPLATELET EFFECTS OF ASPIRIN — Aspirin irreversibly acetylates cyclooxygenase-1, blocking thromboxane synthesis and inhibiting platelet activation and aggregation for...

The FDA has approved the marketing of Vimovo (AstraZeneca), a fixed-dose combination of the nonsteroidal anti-inflammatory drug (NSAID) naproxen and the proton pump inhibitor (PPI) esomeprazole, for symptomatic relief of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk for NSAID-associated ulcers.

Levamisole (Janssen), an old antiparasitic drug widely used for treatment of ascariasis in animals, is now available from the National Cancer Institute (NCI) for investigational use with fluorouracil (5-FU; Adrucil; and others) as an adjuvant for treatment of resectable colon cancer that has metastasized to regional lymph nodes (Dukes stage C).

Since the implication of aspirin in Reye's syndrome, acetaminophen (Tylenol; and others) has become the standard drug for symptomatic treatment of fever and pain in children. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) available for many years in tables (Mortin; Advil; and others), has now become available in a suspension. The suspension will be sold by presecription for treatment of fever or arthritis in children.

Rifabutin (formerly ansamycin; Mycobutin - Adria), a rifamycin antibiotic similar to rifampin (Rifadin, Rimactane) was recently approved by the US Food and Drug Administration for prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.