FDA to launch ‘Drug Watch’ Web site

WASHINGTON — The Food and Drug Administration has drafted a guidance on its proposed “Drug Watch” Web site, which would provide emerging pharmaceutical safety information to consumers. The FDA posted the guidance on its Web site last week.

“The Drug Watch is intended to identify drugs for which FDA is actively evaluating early safety signals. The Drug Watch is not intended to be a list of drugs that are particularly risky or dangerous for use; listing of a drug on the Drug Watch should not be construed as a statement by FDA that the drug is dangerous or that it is inappropriate for use. Rather, inclusion on the Drug Watch signifies that FDA is attempting to assess the meaning and potential consequences of emerging safety information,” the guidance document states.

Factors the FDA will consider when placing a product on the Drug Watch include whether new and emerging safety information could significantly affect prescribing decisions or how patients should be monitored, whether measures can be taken as a result of providing information that could help to prevent or mitigate harm, and whether an off-label use appears to pose a significant risk to patients.

Once a product is on the list, the FDA will remove it when the safety issues are resolved.