The
Food and Drug Administration (FDA) takes a comprehensive approach to
making information on potential drug risks available to the public,
says Paul Seligman, M.D., M.P.H., Associate Director of Safety Policy
and Communication in FDA's Center for Drug Evaluation and Research.
When
FDA receives information about the safety of a drug or other problems
such as medication errors, the agency evaluates how best to communicate
this information—depending on how serious and frequent the problem is,
and whether evidence shows that the reported problem is actually
related to the drug.
"Providing timely information
can help health care professionals and patients make better treatment
choices," Seligman says. "We encourage consumers to talk with their
health care professionals and ask questions about the benefits and
risks of the drugs they are taking."
There are many
different types of communications that inform the public about the safe
use of medicines. So how can you find information about a drug you are
taking, whether it's a new warning, an early communication about an
ongoing safety review, or other FDA actions?
Here are some of the resources that can help you stay informed.
Index to Drug-Specific Information
This
index features an alphabetical listing of drugs that have been the
subject of a Public Health Advisory, a Healthcare Professional
Information sheet, an Early Communication About an Ongoing Safety
Issue, or other important information. www.fda.gov/cder/drug/drugsafety/DrugIndex.htm
Public Health Advisories
These
advisories contain important drug safety information and
recommendations of actions that can be taken to avoid or minimize harm
from a drug. You can access a listing of FDA Public Health Advisories
by date at www.fda.gov/cder/news/pubpress.htm
MedWatch Alerts
MedWatch
provides important and timely medical product information, and is also
a venue for reporting adverse events to FDA. You can sign up to receive
MedWatch notices by e-mail. www.fda.gov/medwatch/
DailyMed
Developed
with the National Library of Medicine, DailyMed is a Web site that
gives physicians and patients electronic access to FDA-approved drug
labels. http://dailymed.nlm.nih.gov
Drugs@FDA
This
resource allows you to search for information about FDA approved brand
name and generic drugs and therapeutic biological products. These are
proteins derived from living material (such as cells or tissues) used
to treat or cure disease. You can search in many ways, including by
drug name and active ingredient. www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
FDA Drug Safety Podcasts
Podcasting
is a method of publishing and syndicating audio broadcasts through the
Internet. These podcasts provide emerging safety information about
drugs in conjunction with the release of Public Health Advisories. www.fda.gov/cder/drug/podcast/default.htm
FDA Drug Safety Newsletter
Aimed
at health care professionals, this quarterly publication is designed to
enhance communication of safety information after a drug is marketed.
The newsletter raises awareness of adverse events and stimulates
reporting of adverse events. www.fda.gov/cder/dsn/default.htm
FDA Consumer Health Information
FDA
offers timely and easy-to-read articles on product approvals, safety
warnings, and other health information. Articles cover all
FDA-regulated products, including human drugs, drugs and feed for
animals, medical devices, vaccines, blood, food, dietary supplements,
and cosmetics. To find these articles, visit the Web page at www.fda.gov/consumer/default.htm
You can also sign up to receive notices of new consumer articles at www.fda.gov/consumer/consumerenews.html
Recalls, Market Withdrawals and Safety Alerts
FDA
provides information on drug products that have been recalled due to
manufacturing problems and/or safety concerns. In addition to
information released to the public by a manufacturer using the normal
media channels, FDA posts information about these recalled drug
products at www.fda.gov/opacom/7alerts.html
You can also sign up to receive e-mail notices of product recalls.
For More Information
A Guide to Drug Safety Terms at FDA
www.fda.gov/consumer/updates/drugterms041108.html
FDA 101: Medication Errors
www.fda.gov/consumer/updates/medicationerrors031408.html
Managing Drug Safety Issues
Q and A with Paul Seligman, M.D., M.P.H.
www.fda.gov/consumer/updates/drugsafetyqa053107.html
FDA Launches Drug Safety Newsletter
www.fda.gov/consumer/updates/dns092107.html
Strengthening Drug Safety
www.fda.gov/consumer/features/drugsafety0607.html
Date Posted: April 11, 2008
