FDA Safety Disclosures for New Drugs

Every day more than 47 percent of the population in the United States takes a prescription medication, according to 2003-2006 study performed by the Centers for Disease Control and Prevention (CDC). That number has steadily increased in recent years from 39 percent in 1988-1994.

To ensure that doctors and patients are fully informed of the risks of prescription medicines, the U.S. Food and Drug Administration (FDA) unveiled a new online process for posting up-to-date information. The online summaries will include important risks that may only become apparent after the drug has gone to the market.

New Guidelines for FDA Updates

In the past, the FDA only provided online safety updates when a medication had an urgent safety issue associated with its use. Now, the FDA will be regularly reviewing the safety and effectiveness of all prescriptions and publishing the results on its website.

The online summaries are partly because many medication side effects do not become apparent until after the medication has been released into the market.

Online Medication Summaries

The types of information likely to be included in the new FDA summaries include:

  • Adverse effects and reactions
  • Steps undertaken to correct safety issues
  • Harmful chemical reaction updates

The FDA has said that the new online summaries will help to educate patients and doctors about the ongoing risks of particular medicines and prevent harmful side effects. The FDA will rely on information provided by drug manufacturers, physicians and consumers to compile the online summaries.