Celecoxib, a selective COX-2 inhibitor, has been approved by the FDA for treatment of osteoarthritis and rheumatoid arthritis.

The FDA has required a new warning in the labels of prescription and over-the-counter products containing nonsteroidal anti-inflammatory drugs (NSAIDs) advising against their use during pregnancy beginning at 20 weeks’ gestation because of a risk of renal dysfunction in the fetus that could lead to low amniotic fluid levels (oligohydramnios) and neonatal renal impairment. NSAID labels previously warned against use of the drugs beginning at 30 weeks' gestation because of a risk for premature closure of the ductus arteriosus and persistent neonatal pulmonary hypertension

Diclofenac epolamine patch 1.3% (Flector Patch - Alpharma), a topical formulation of the nonsteroidal anti-inflammatory drug (NSAID) diclofenac, has been approved by the FDA for topical treatment of acute pain due to minor strains, sprains and contusions. It is the first topical NSAID patch approved in the US. A diclofenac patch has been used in Europe since 1993. Diclofenac sodium (Voltaren, and others) is available in the US as an oral tablet, in a 1% gel for treatment of osteoarthritis (to be reviewed in a future issue), in a 3% gel (Solaraze) for treatment of actinic keratoses, and in an...

Tacrolimus (Prograf - Fujisawa), previously called FK506 (Medical Letter, 33:94, 1991), has been approved by the US Food and Drug Administration for primary prevention of organ rejection in patients receiving liver transplants. The drug has also been used as rescue therapy for organ graft rejection unresponsive to cyclosporine (Sandimmune) and other immunosuppressive drugs.

The FDA has approved Anjeso (Baudax Bio), an IV formulation of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam, for once-daily treatment of moderate to severe pain in adults. Oral meloxicam (Mobic, and others), which is only indicated for treatment of chronic pain associated with osteoarthritis or rheumatoid arthritis, has been available for 20 years. IV formulations of ketorolac, ibuprofen (Caldolor), and acetaminophen (Ofirmev) are also available for treatment of pain.

Ketorolac (kee'; toe role ak) tromethamine (Toradol), manufactured by Syntex but also marketed by Roche, is the first parenteral nonsteroidal anti-inflammatory drug (NSAID) to become available for analgesic use in the USA. Parenteral indomethacin (Indocin I.V.) has been marketed here since 1985, but only for treatment of patent ductus arteriosus in newborn infants. Other parenteral NSAIDs are available in other parts of the world, but low potency, poor aqueous solubility, and substantial tissue irritation on injection have limited their usefulness. Ketorolac has been approved by the US ...

The FDA has approved prasugrel (Effient - Lilly/Daiichi Sankyo), an oral antiplatelet drug, for use with aspirin to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndromes (ACS) being managed with percutaneous coronary intervention (PCI). It will compete with clopidogrel (Plavix) for such use.

Older patients are especially susceptible to drug-induced cognitive impairment. They are more likely to be taking multiple drugs, to have higher blood levels of those drugs because of renal or hepatic dysfunction, and to have pre-existing cognitive problems that make it difficult to detect the role of drugs causing new symptoms or making old ones worse.

Recent reports indicate that intramuscular (IM) injection of the nonsteroidal anti-inflammatory drug (NSAID) ketorolac (Toradol, and others), sometimes directly into injured muscles, has become a common practice in US locker rooms.

Febuxostat (Uloric - Takeda), a xanthine oxidase inhibitor, has been approved by the FDA for chronic management of hyperuricemia in patients with gout. It is the first drug marketed for treatment of gout in 40 years. Febuxostat is structurally unrelated to allopurinol, the only other commercially available inhibitor of xanthine oxidase. Xanthine oxidase inhibitors decrease serum urate concentrations by decreasing urate synthesis.