Volume XII, Issue 12

With this issue, we inaugurate a sectional approach to Drug Therapy. Topics each month may include:

· Drug Information
· Drug Therapy Committee Meeting Highlights
· Managed Care
· Patient Safety
· Pharmacy Performance Improvement

Valdecoxib (Bextra®) Updates Package Labeling
Robert K. Hallisey, Jr. MS RPh, Pharmacy Clinical Coordinator

FDA and Pharmacia are advising health care professionals about new warnings and information in the product labeling of the drug valdecoxib (Bextra® ), a drug approved for treatment of osteoarthritis, rheumatoid arthritis and dysmenorrhea. The labeling is being updated with new warnings following postmarketing reports of serious adverse effects including life-threatening risks related to skin reactions (including Stevens-Johnson Syndrome), and anaphylaxis. In addition, the labeling will state that the drug is contraindicated in patients allergic to sulfa-containing products.

Meloxicam (Mobic® ) and rofecoxib (Vioxx® ) can be given safely in patients with previously demonstrated sensitivity to sulfa-containing products. Celecoxib (Celebryx® ) also carries a contraindication in patient allergic to sulfa-containing products.

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Previous Issues

Highlights from Drug Therapy Committee Meeting November 2002

Formulary Actions:

AVAILABLE: Entacapone (Comtan® )

The Committee approved the addition of entacapone (Comtan® ) to the Formulary. Entacapone is a selective catechol-O-methyltransferase (COMT) inhibitor indicated for the adjunctive treatment of patients with idiopathic Parkinson's disease who experience end of dose "wearing off" symptoms with levodopa/carbidopa. Entacapone has no antiparkinson effects of its own, but rather increases levels of levodopa by inhibiting peripheral COMT. Efficacy data suggest that entacapone increases "on" time and decreases "off" time and may allow lower doses of levodopa/carbidopa in patients with motor fluctuations. Major side effects of entacapone are related to its dopaminergic effects, including dyskinesias, anorexia, insomnia, orthostatic hypotension, syncope, nausea, and vomiting. Unlike the other COMT inhibitor currently on the market, tolcapone (Tasmar® ), entacapone has no reports of hepatotoxicity to date. The Committee has approved the removal of tolcapone (Tasmar® ) from the Formulary due to low utilization.