FDA Alerts

FDA alerts to the public are made when there is an FDA action. The FDA seeks publicity about a recall only when they believe the pubic needs to be alert to a serious hazard. A first alert to the FA happens in several ways:

• A company discovers a problem and contacts the FDA.
• The FDA inspects a manufacturing facility and determines the potential for a recall.
• The FDA receives reports of health problems through various reporting systems.
• The Centers for Disease Control and Prevention (CDC) contacts the FDA.

When it comes to illnesses associated with food products, the FDA generally first hears of this from the CDC.

When a recalled product has been widely distributed, the news media is a very effective way to reach large numbers of people. The FDA alerts can be in the form of press conferences, press releases and posted updates to the website. If there is a great health risk, the FDA will offer media updates every day to give new information.

Not all recalls are an FDA alert. But, all recalls go into the FDA’s weekly Enforcement Report. The following products are subject to FDA recalls.

• Human drugs
• Animal drugs
• Medical devices
• Radiation-emitting products
• Vaccines
• Blood and blood products
• Transplantable human tissue
• Animal feed
• Cosmetics
• About 80 percent of the foods eaten in the US

When an FDA-regulated product is either defective or potentially harmful, recalling that product is the most effective means for protecting the pubic. Recalls are almost always voluntary and when a company discovers a problem, it recalls the product on its own. Only in rare cases will the FDA request a recall.

FDA alerts are listed on several different websites such as: http://twitter.com/DrugscomAlerts and

http://www.drugs.com/fda_alerts.html. The FDA alerts are for:

• Safety Reviews
• Label Changes
• Market Withdrawals
• Undeclared Drug Ingredient
• Consumer Warning

The FDA MedWatch is the Safety information and Adverse Event Reporting Program. MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements and cosmetics. The alerts contain actionable information that may impact both treatment and diagnostic choices for healthcare professionals and patients.

There is an archival library of all MedWatch alerts. You can access it through:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/default.htm. You can also subscribe to a MedWatch E-list at this site.

Alerts are the FDA mechanism for notifying the public and health professionals of adverse events and potential violations.

Written by: Margaret Stenerson

10 9 2010