Information on Rheumatology Therapeutics:
Safety Information

The overall safety of the drugs and biologics used in rheumatology is an important consideration when selecting from available therapies.  The initial safety results from human and animal studies are included in the label of the product once approved by the FDA for marketing.  Information on the most recent label can be found at Drugs@FDA or the National Library of Medicine DailyMed.

Some FDA-approved products also contain patient labeling such as Patient Package Inserts and Medication Guides to help communicate the risk of the therapy.

Additional information about important new post marketing findings for the therapy may be found at MedWatch program.

The following links will provide more information on ongoing safety initiatives at FDA:

• FDA Drug Safety Initiative
• FDA drug safety podcasts.
• Recalls, Market Withdrawals and Safety Alerts
• FDA Press Releases
• CDER Drug Safety Newsletter
• CDER Drug-Specific Information
• Public Health Advisories
• CBER safety information (includes gene therapy)
• Patient Safety Video Webcasts
• List of Pregnancy Exposure Registries

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Date created: October 15, 2008

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