FDA urges genetic test before using Glaxo AIDS drug (Reuters via Yahoo! News)
and urged its inclusion in Ziagen's prescribing instructions, Rhyne declared.
The recommendation for the screening test is now included in a "black box" on Ziagen's label. A black box is the strongest type of warning for prescription drugs.
The step is not the same move toward personalized medicine, a drive to determine which drugs work best, or may be mischievous, for individual patients.
In Glaxo's study, excluding people with the gene diversity cut the reaction abuse to 3.4 percent from 7.8 percent.
Based on those findings, it was estimated that 61 percent of patients with the deviation would develop the reactions, compared with 4 percent of those without it, the Ziagen label says.
Symptoms of the reactions include fever, rash, nausea, vomiting and fatigue.