What is the Drug Safety Newsletter?

The Drug Safety Newsletter is a source of information for healthcare professionals about the findings of selected postmarketing drug safety reviews from FDA's Center for Drug Evaluation and Research (CDER). The Newsletter also provides information on important emerging drug safety issues and recently approved new molecular entities. We expect to publish the Newsletter quarterly. Launched in September 2007, the Drug Safety Newsletter is produced by CDER's Safety Policy and Communication Staff. It is one of FDA's tools to communicate evolving safety information about pharmaceutical products regulated by CDER.

Who is the target audience?

Our target audience is healthcare professionals, such as physicians, physician assistants, nurse practitioners, nurses, pharmacists, dentists; other allied healthcare professionals; health professional associations; and drug information centers. The Drug Safety Newsletter is publicly available on FDA's Web site.

What is the purpose of publishing the Drug Safety Newsletter?

The Newsletter provides postmarketing information to healthcare professionals to enhance communication of new drug safety information, raise awareness of reported adverse events, and stimulate additional adverse event reporting.

We expect that the Newsletter will provide information useful to doctors and other healthcare professionals in making decisions about the use of medicines in their practice. Decisions about how to use this information in the care of individual patients should be made by those healthcare professionals. Patients concerned about the products they are taking should consult their doctor or pharmacist and should not change or discontinue therapies prior this consultation.

What is the relationship between the Drug Safety Newsletter and other FDA mechanisms for communicating drug safety information to the public?

FDA-approved drug product labeling is the primary source of information about a drug's safety and effectiveness, and it summarizes the essential scientific information needed for the safe and effective use of the drug. As described in the Guidance on Drug Safety Information -- FDA's Communication to the Public, the Agency uses a variety of methods to communicate important drug safety information to the public in a timely manner, including Public Health Advisories and Alerts on Healthcare Professional Sheets for emerging drug safety information. This quarterly Newsletter is intended to complement these other methods of communication.

What are the main features of the Drug Safety Newsletter?

The Newsletter presents data primarily from adverse event reports submitted to FDA's Adverse Event Reporting System (AERS). The AERS database receives several hundred thousand adverse event and medication error reports every year related to drug safety from manufacturers, healthcare professionals, and the public. The main utility of reviewing AERS data is to identify signals of potential drug safety issues.

Some articles in the Drug Safety Newsletter will be based on postmarketing drug safety reviews routinely conducted by FDA's Office of Surveillance and Epidemiology (OSE), based primarily on adverse event reports from the AERS database. Other articles will be based on reviews of safety information from other sources, such as postmarketing clinical or pharmacoepidemiology studies. Articles may focus on a specific drug, or class of drugs. Articles may address emerging drug safety issues (in connection with FDA's other methods of communicating emerging drug safety information) or safety information that is fully developed.

The Newsletter also is intended to routinely report on postmarketing findings for a recently approved new molecular entity (NME). Postmarketing safety reviews of approved NMEs are carried out at periodic intervals within CDER (Office of Surveillance and Epidemiology, Office of New Drugs, and the Office of Translational Sciences). An NME is a medication containing an active substance that has never before been approved for marketing in any form in the United States.

Each issue of the Drug Safety Newsletter will include a list of public health advisories and healthcare professional information sheets posted by FDA in the previous quarter.

How are topics for Drug Safety Newsletter articles selected?

We base our coverage on factors such as (1) the likely importance of a topic for patient care and public health, (2) the seriousness of an adverse event, and (3) the timeliness of a topic given other publications or events of public interest. We also plan to feature topics of special interest, such as interesting clinical or methodological approaches to drug safety questions.

What is an adverse drug experience?

As described in FDA's regulations at 21 CFR 314.80(a), an adverse drug experience is any adverse event associated with the use of a drug in humans, whether or not considered drug related, including the following:

• An adverse event occurring in the course of the use of a drug product in professional practice
• An adverse event occurring from drug overdose whether accidental or intentional
• An adverse event occurring from drug abuse
• An adverse event occurring from drug withdrawal
• Any failure of expected pharmacological action

What is an adverse event report?

An adverse event report is a communication to the FDA of an undesirable sign or symptom associated with use of a drug (as required and detailed by 21 CFR 314.80, see also 21 CFR 310.305, 314.98, and 600.80). These reports are logged into FDA's Adverse Event Reporting System (AERS). Drug manufacturers are required to report adverse event information to FDA. These reports also may be voluntarily submitted to the FDA directly by healthcare professionals or the general public at http://www.fda.gov/medwatch/report.htm. The reports are reviewed, safety issues are monitored, and data are periodically analyzed and assessed by CDER.

What are the limitations of adverse event reports?

There are inherent limitations to a voluntary reporting system for adverse events associated with the use of a drug, including but not limited to, underreporting, duplicate reporting, and reporting biases. Furthermore, for any given report, the reported adverse event(s) may not be causally related to the product(s) reported to have been taken. The event may have been related, for example, to the underlying disease being treated, to other medical conditions, or to another product taken at the same time. The number of cases reported to FDA's Adverse Event Reporting System (AERS) cannot be used to calculate the incidence rates, to estimate drug risk for a particular product, or to compare risks between products.

Will the Drug Safety Newsletter lead to more adverse event reporting?

The Drug Safety Newsletter is a drug safety communication tool alerting healthcare professionals to potential postmarketing safety signals detected through postmarketing review of case reports submitted to FDA. The mention of a safety issue in the Newsletter may lead to an increase in adverse event reporting. This stimulated reporting often occurs following any risk communication or media attention to a particular safety issue due to enhanced awareness, and we hope the Drug Safety Newsletter stimulates additional adverse event reporting. FDA reviewers weigh the effects of such stimulated reporting in their analyses.

How is the Drug Safety Newsletter distributed?

The Newsletter is distributed electronically to U.S. healthcare professionals who subscribe to the Drug Safety Newsletter or to the MedWatch E-list. The Drug Safety Newsletter will be available on the FDA Web site beginning September 2007 and can be accessed at http://www.fda.gov/cder/dsn/default.htm.

How can I subscribe to the Drug Safety Newsletter?

We invite you to subscribe to the Drug Safety Newsletter. Subscribers to the Newsletter will receive a message every time a new issue is available. Healthcare professionals and consumers can also subscribe to the MedWatch E-list to receive concise, timely, and important medical product safety information about the drugs and devices they use, prescribe, or dispense every day at point of care.

1. Subscribe to the Drug Safety Newsletter. Enter your name and e-mail address in the appropriate fields and select the Join the List button.
2. Subscribe to the MedWatch E-list. Enter your name and e-mail address in the appropriate fields and select the Join the List button.

What are the current policies and procedures that govern the production and distribution of the Drug Safety Newsletter?

We invite you to view the current Manual of Policies and Procedures at http://www.fda.gov/cder/mapp/4151.6.pdf .