New FDA Database Ensures Timely Access to Drug Safety Labeling Changes

February 03, 2017 04:31 pm News Staff

Family physicians may not be aware of a new FDA database that drastically improves timely access to information on drug safety labeling changes.

The database, part of the FDA's official website, was launched a few months ago by the FDA's Center for Drug Evaluation and Research.

The agency now is leading a push to ensure physicians and other health care professionals, health IT vendors and consumers understand they can get to critical safety data that could impact patients' health much more quickly than in the past.

Speed is the name of the game. The user-friendly and searchable database(www.accessdata.fda.gov) provides updates on labeling information, usually within days of safety labeling changes. Physicians can search by drug name, active ingredient, date range or labeling section.

A quick reference guide(www.fda.gov) will help first-time users get started.

Safety labeling changes have been available online to physicians and others who need access for years, but the information was posted on a monthly basis. That meant when a labeling change was approved early in a month, the information was not made public until the following month -- weeks later.

Lest readers imagine that drug safety label changes are a rare event managed the FDA, numbers tell the real story: Between January 2015 and July 2016 more than 1,650 safety label changes were administered; those changes were related to

  • boxed warnings (87);
  • contraindications (83);
  • warnings (452);
  • precautions (548);
  • adverse reactions (362); and
  • patient counseling information, patient information and medication guidelines (144).

According to a notice(www.fda.gov) posted on the FDA website, the agency expects that physician access to the safety data ultimately will improve the health of patients.

The database includes safety labeling changes from January 2016 forward. Physicians needing data from an earlier time frame can find it on MedWatch(www.fda.gov).