Drug safety- FDA concern about black box warning

[Guest guest]

Dear Members,

How does FDA evaluate drug safety information?

All drugs have risks, and healthcare professionals and patients must balance the risks and benefits of a drug when making decisions about medical therapy. FDA monitors and reviews available safety information related to marketed drugs throughout each drug product’s lifecycle.

When a drug is approved, the product labeling includes, among other things, available information about the benefits and risks of the drug. After drug approval, the Agency may learn of new, or more frequent, serious adverse drug experiences from post-approval clinical studies or from clinical use.

For example, additional adverse drug experiences may be identified as a drug is used more widely and under more diverse conditions (e.g., concurrently with other drugs), or as the drug is prescribed for off-label uses.

Tarun Wadhwa