FDA Urged To Include More Drug Safety Information On Labels

In a recent article the AP reports, "In this week's issue of the New England Journal of Medicine, researchers from Dartmouth College argue that drug labels don't reflect the nuanced decisions the FDA makes when deciding to approve a drug." The editorial by Drs. Lisa Schwartz and Steven Woloshin say that "much of what the Food and Drug Administration knows about a drug's safety and effectiveness is not included on the label" and recommend "easy-to-read fact boxes to help patients weigh the benefits and risks of medications." Schwartz said, "just because a drug is approved doesn't mean it works very well." She used Lunesta [eszopiclone] as an example, noting that the anti-insomnia drug only helped patients fall asleep 15 minutes faster. "FDA review documents can also hide critical safety information," such as with Zometa [zoledronic acid], where the information about death rates is missing from the label. "Earlier this year, the FDA's panel of communication experts recommended the agency adopt fact boxes for all announcements about drug risks and benefits."

Art Kosieradzki