Drug safety relies on you, the healthcare professional, find and report new serious adverse reactions.

You as a vigilant healthcare practitioner (HCP) can make a major contribution to public health by participating in the Food and Drug Administration's (FDA's) Spontaneous Reporting System. This means you! How can we help ensure a drug is safe once approved by FDA?

An adverse drug reaction begins as a clinical problem in a single person or group of individuals.

Until that problem is reported to the sponsor and/or to the FDA, it is hidden and likely unknown to the medical community.

All potential problems with a drug cannot always be found through clinical trials. Only after it is marketed, when the drug is used by diverse patients with a wide spectrum of healthcare concerns, do unforeseen and rarer adverse events show themselves.

FDA and sponsors cannot examine problems they do not know exist. Timely reporting of adverse events is fundamental to the success of the FDA's surveillance program, especially in the case of newly marketed drugs. It is vitally important that HCPs communicate suspected serious, new drug-associated events to the FDA and/or the pharmaceutical sponsor.

You the healthcare practitioners are on the front line and your reports truly make a difference. New safety issues can be discovered, reported and alerts can go out to the entire medical community. It is a simple and obvious way to save many lives!

Sadly most do not report. We need to change that.

We encourage all HCP to post in their facilities the reporting methods for adverse events to the FDA:

Report New Serious Adverse Reactions to FDA or to drug sponsor: Phone (1-800-FDA-1088), Fax (1-800-FDA-1078), online at https://www.accessdata. fda.gov/scripts/medwatch/ To the sponsor at the phone number in the product label.