Adverse event reporting is valued information

By Pat Clarke, Office of Communications, CDER

Potential drug treatments are tested on paper, in laboratories and eventually in thousands of people. But every drug that goes through this cycle – every drug that FDA approves – carries some risk. One of the first lines of defense against serious side effects and other problems related to drugs is you. FDA can work to ensure a product’s safety when consumers report any issues with their medicine to the Agency, their doctor or the manufacturer.

MedWatch is the FDA’s safety information and adverse event reporting program that helps health care providers and consumers notify the Agency of faulty medicines and other risks related to drugs. “It’s important that we get as much information as possible on adverse events from consumers, because good information can be evaluated,” said Melissa Truffa, R.Ph., associate director, Division of Pharmacovigilance, Office of Surveillance and Epidemiology.

When to report

Unlike for the drug industry, there are no legal requirements for a consumer to report adverse events -- but they should. “A patient should report if they had a significant outcome – such as having to go to the hospital as a result of a medication they took or if they have to stop taking the medication because of an adverse event,” said Truffa.

FDA encourages patients to report adverse events as soon as possible. If the adverse event team gets a cluster of reports about the same drug in a short period of time, they will be able to respond more quickly.

Information needed and confidentiality

FDA staff may contact a patient directly to ask for more information about the reported problem. “If we need to contact a patient’s health care provider, we would ask for permission from the patient,” said Truffa.

The information a patient gives is strictly confidential, and no names are ever used.

What happens after a report is made

FDA reviews all submitted MedWatch reports for safety signals -- similar adverse events occurring with a particular drug. Some examples include:

A new serious adverse event not listed in the drug’s package insert
An increase in the reporting of an event already occurring with a drug
A new drug-drug interaction
Or confusion with a product’s name, packaging or labeling leading to an adverse event

Depending on the information found during the FDA’s review of the safety signal and the severity of the adverse event, FDA may decide to:

Update the drug’s package insert or labeling
Place restrictions on the drug’s distribution
Release a drug safety communication to inform the public
Withdraw the drug from the market

Once the issues are determined, FDA has a number of ways to alert the public about safety issues: e-mails, websites, social media outlets, and through the media.

But almost everything starts with consumer feedback. “Adverse event reporting allows us to do our job and report needed information back to consumers, said Truffa. “We value the information everyone sends.”

Related InformationHow to report to MedWatch¹