Adverse Drug Reactions Not Being Reported

A recent analysis found that information about adverse drug reactions in infants and newborns may not be reported properly.

Adverse drug reactions could pose a serious health threat to individuals, especially young children and the elderly. By not reporting reactions, drug manufacturers may not be aware of all reactions the drug may cause.

In the United States, the FDA Adverse Event Reporting System compiles information regarding adverse events and medication errors. The database supports post-marketing safety surveillance that the FDA conducts to ensure that approved medications are safe in real-world settings.

Reports can be made by clinicians, healthcare professionals, and consumers. In the UK, the Medicines and Healthcare Products Regulatory Agency runs the Yellow Card Scheme, which is a reporting system that collects information about adverse drug reactions, and other adverse incidents with a device.

The Medicines and Healthcare Products Regulatory Agency reviews the submitted product information, and takes action if necessary. After reports are reviewed by medical experts and a new adverse event is identified, they will change the safety profile of the medication.

Without the original reports from consumers and healthcare professionals, the adverse event may continue to affect unsuspecting patients. In the current study, published by the British Journal of Clinical Pharmacology, scientists analyzed data from the reporting system from 2001 to 2010.

They discovered that spontaneous reports alone are not generating enough of the required data for adverse events in young children. They also found that the reporting patterns are not consistent with safety messages from the regulator.

Scientists suggest that additional reporting strategies are needed to improve the quality and quantity of data for adverse drug reactions, according to the study.

“The UK set up the first system in the world to report adverse drug reactions, the Yellow Card Scheme, over 50 years ago. It has helped improve the safety of drugs immensely by identifying adverse drug reactions, and continues to be valuable today,” said lead study author Daniel Hawcutt, BSc, MB ChB, MD, MRCPCH. "This research shows that for newborn babies and infants, the spontaneous reporting of adverse drug reactions may not be enough, and additional systems to seek out and report adverse drug reactions are required."