The FDA MedWatch is part of the Safety information and Adverse Event Reporting Program. It is the gateway for finding clinically important safety information and reporting serious problems with human medical products. MedWatch provides timely new safety information on:

• Human drugs
• Medical devices
• Vaccines
• Other biologics
• Dietary supplements
• Cosmetics

These FDA alerts contain actionable information, such as FDA recalls, that may impact both the treatment and diagnostic choices for health care professionals and patients. The two way street allows any one to file a report online concerning adverse side effects and defective medical devices

This FDA MedWatch program also includes drug safety labeling changes. The changes could be to the:

• Boxed warning
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Patient package insert/Medication guide

There is a MedWatch Online Voluntary Reporting Form (3500) to report serious adverse events for human medical products, including potential and actual product use errors and product quality problems associated with the use of:

• FDA-regulated drugs
• Biologics, including human cells, tissues, and cellular and tissue-based products
• Medical devices, including in vitro diagnostics
• Special nutritional products
• Cosmetics

A person can make adverse event reports under the Health Insurance Portability and Accountability (HIPAA) Privacy Rule. The HIPAA Privacy Rule is not intended to disrupt or discourage adverse event reporting in any way. The Privacy Rule specifically permits pharmacists, physicians or hospitals to report adverse events and other information related to the quality, effectiveness and safety of FDA-regulated products both to the manufacturers and directly to the FDA.

There are three categories NOT to report to MedWatch using online form 3500. They are:

• Vaccines:

o   Report vaccine events to the Vaccine Adverse Event Reporting System online at https://secure.vaers.org/VaersDataEntryintro.htm.

• Investigational (study) drugs:

o   Report study drug adverse events as required in the study protocol and send to the address and contact person listed in the study protocol.

• Mandatory reporting:

o   Drugs and biologics – use Form 3500A

o   Devices – use Form 3500A

Archival MedWatch information is available at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/default.htm

The FDA MedWatch program is the Agency’s attempt at transparency. Any citizen can file a report or complaint of adverse reactions to drugs or malfunctioning devices at the FDA website.

Written by: Margaret Stenerson

10 9 2010