FDA Drug Safety Communications

What You Need to Know When You Need to Know It

Gregory D. Busse, PhD


July 27, 2012

Editorial Collaboration

Medscape &

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I am Dr. Gregory Busse, team lead for Drug Safety Communication within the Food and Drug Administration (FDA) Center for Drug Evaluation and Research. It is my pleasure to spend some time discussing FDA's Drug Safety Communication program with the Medscape audience, given the importance of these communications to clinical practice.

The Drug Safety Communication program was established to provide the healthcare community and the public with timely, accurate, new, emerging, and established risk-benefit information for FDA-approved drugs. Sometimes, as a drug is used in the real-world setting, post approval, new data emerge that suggest that the risks of using the drug -- the relation of these risks to its benefits -- have changed. Communicating this information to those who prescribe or use the drug is of utmost importance to the FDA. We realize that this information can impact patient safety and prescribing decisions. In addition, it can also facilitate effective discussions on appropriate medical care between healthcare professionals and patients.

We issue many Drug Safety Communications, but they are not all the same. Sometimes we issue a Drug Safety Communication early in our investigation of a potential new drug safety issue. These early communications let the public know that the FDA is aware of some new data that could potentially affect the benefit-risk profile of a drug, though no conclusion has been made yet by the FDA.

A Drug Safety Communication is also issued when FDA decides that the drug safety data warrant a change in how the drug is used. These Drug Safety Communications will summarize the safety signal, including any changes to the professional label. They will provide the steps healthcare professionals and patients can take to minimize or mitigate any potential risks and/or maximize the drug's benefits. We also include a summary of the data we used in the FDA's decision.

We also issue Drug Safety Communications when more restrictive directions for use of a drug are no longer needed, and we update Drug Safety Communications when additional information on an established and communicated safety signal comes to light. By providing this information, we hope to improve the safe use of medicine and inform the public on FDA's activity in the area of drug safety.

What can you expect when looking at an FDA Drug Safety Communication? We write Drug Safety Communications with multiple audiences in mind. There is information for the patient or consumer. And there is information for the healthcare professional. We want to make sure everyone has the information they need to make the most informed decision about the medicines they are using or prescribing.

We are aware that most people, including healthcare professionals, receive information on drug safety through many mechanisms. That is why we partner with many professional organizations, contact the media, and use social media, like the FDA Twitter feed, to get the drug safety message out. If you have any questions about any of the information you receive on drug safety, please do not hesitate to contact FDA's drug information line at 888-463-6332.

You can also access Drug Safety Communications directly by signing up for the MedWatch listserve. Every Drug Safety Communication is sent out to subscribers in a MedWatch alert.

All Drug Safety Communications are also posted on the Drug Safety Communications page. Here you will find our most recent drug safety communications, past communications issued on a safety issue, and Drug Safety Communications translated into Spanish -- our most recent efforts to expand accessibility to this important information. We encourage you to visit this page and look for drug safety communications most relevant to you or your clinical practice.

Finally, I should also mention that our Drug Safety Communication program is evolving. It has to, given the shifting landscape of how we get and use our information. People are relying more on the use of social media, smartphone technology, and apps. We have an active research program evaluating how drug safety information can be effectively disseminated through multiple channels. We are always looking for new ways to reach our healthcare-professional audience and look forward to providing you with the information you need.

Communicating drug safety information is the responsibility of all parties with a vested interest in patient safety, and we look forward to our continued partnership with you.


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