Drugs

Tracking Drug Adverse Events

CDER Office of Surveillance and Epidemiology director Gerald Dal Pan says that although the number of reports to the FDA Adverse Event Reporting System (FAERS) reached a record of more than two million in 2018, that does not suggest that FDA-approved drugs have become riskier. In a CDER Conversation: Tracking and Acting on Safety Data Through a Drug’s Lifecycle, Dal Pan says the increase “reflects the fact that more drugs are on the market. It also suggests that stakeholders have become more aware of the value of reporting adverse events to help us enhance drug safety.”

Once a new risk associated with a drug has been confirmed, Dal Pan says, the agency generally requires that the risk be added to the drug’s label. If there is a potential for serious adverse effects, it may also require the manufacturer to develop a Risk Evaluation Mitigation Strategy to ensure that the drug’s benefits outweigh the risks. In rare situations, he says, a drug may be removed from the market.

Since new risks are added to labeling after a drug has been approved, Dal Pan says, healthcare professionals should read drug label updates issued by FDA to ensure they are up-to-date on the latest risk information.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome