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The
Food and Drug Administration (FDA) approves a drug for marketing after
determining that the drug's benefits of use outweigh the risks for the
condition that the drug will treat. But even with a rigorous evaluation
process, some safety problems surface only after a drug has been on the
market and has been used in a broader population. This guide offers
descriptions of some of the drug safety terms commonly used by FDA
throughout the life cycle of a drug.
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FDA REVIEW
Pre-Clinical Data:
Before a drug can be tested in people in the United States, sponsors
(drug manufacturers, research institutions, and other organizations
that develop drugs) must show FDA results of testing they have done in
laboratory animals and what they propose to do for human testing.
New Drug Approval Process:
After the animal testing stage, FDA decides whether it is reasonably
safe for the company to move forward with clinical trials—studies that
evaluate the safety and effectiveness of a drug in healthy people and
in patients. The drug company submits the results of such studies to
FDA for review. The agency conducts a thorough review of the safety and
effectiveness data, and considers how the benefits compare to the risks
when making a decision of whether or not to approve a drug.
Adverse Drug Reaction:
An adverse drug reaction, also called a side effect, is any undesirable
experience associated with the use of a medicine in a patient. Adverse
events can range from mild to severe. Serious adverse events are those
that can cause disability, are life-threatening, result in
hospitalization or death, or are birth defects.
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TAKING MEDICATION
Medication Guides:
Medication Guides are paper handouts/pamphlets that are required to be
distributed to patients with certain medications by the pharmacist.
Medication Guides convey risk information that is specific to
particular drugs and drug classes, and they contain FDA-approved
information that can help patients avoid serious adverse events. www.fda.gov/cder/Offices/ODS/medication_guides.htm
Consumer Medication Information (CMI):
Compared to a Medication Guide, a Consumer Medication Information sheet
offers broader information on how to use a medicine. CMI sheets are not
developed or regulated by FDA. These information sheets are prepared by
pharmacies and given out with prescription drugs. CMI sheets are not
available on the FDA Web site. The sheets help consumers understand key
information about their prescription medicine, including how to take
it, how to store it, and how to monitor their treatment. The sheets
also include information on precautions and warnings, as well as
symptoms of serious or frequent adverse events and what to do if you
experience one.
Prescription Drug Labeling:
Drug labeling, commonly called the package insert or the prescribing
information, provides information to the physician about what a
prescription medication is supposed to do, who should and should not
take it, and how to use it. Labeling also includes information on a
drug's side effects and warnings, and information from the clinical
trials of the drug. Some prescription drug labeling also includes a
part that describes the prescribing information in words that consumers
will understand.
Nonprescription Drug Label ("Drug Facts"):
For an over-the-counter (OTC), or nonprescription medicine, information
printed on the medication bottle or package under the heading Drug
Facts is important for taking care of yourself and your family. The
Drug Facts tell you what a medicine is supposed to do, who should or
should not take it, and how to use it. Safety information and
instructions for use are displayed in a uniform and easy-to-read
format.
Boxed Warning: This type of
warning is also commonly referred to as a "black box warning." It
appears on a prescription drug's label and is designed to call
attention to serious or life-threatening risks.
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MONITORING AFTER APPROVAL
Post-Market Surveillance:
Post-market surveillance is the process by which a drug's safety is
monitored on an ongoing basis after a drug is approved by FDA.
Post-market surveillance seeks to identify problems that were not
observed or recognized before approval and any problems that may arise
because a drug may not be used as described in the drug labeling, or
because a drug is being manufactured incorrectly.
Adverse Event Reporting System (AERS):
AERS is a computerized database containing reports of adverse events.
It supports FDA's post-market safety surveillance program for all
approved drugs and therapeutic biologics. www.fda.gov/cder/aers/default.htm
MedWatch:
MedWatch is FDA's safety information and adverse event reporting
program. It provides important and timely medical product information
to health care professionals, including information on prescription and
over-the-counter drugs, biologics, medical devices, and special
nutritional products. Health care professionals and consumers can also
report serious problems they suspect are related to certain
FDA-regulated products. www.fda.gov/medwatch/safety.htm
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REMOVAL FROM THE MARKET
Drug Recall:
A drug recall is an action taken by a firm to remove a product from the
market that FDA considers to be in violation of the law. Recalls are
classified as Class I, Class II, or Class III. Class I recalls are the
most serious and involve situations where there is a reasonable
probability that the use of or exposure to a violative product, will
cause serious adverse health consequences or death. A drug may be
recalled due to factors such as problems with packaging, manufacturing,
or contamination.
Drug Withdrawal: In
rare cases, FDA may need to reassess and change its approval decision
on a drug. A conclusion that a drug should no longer be marketed is
based on the nature and frequency of the adverse events and how the
drug's benefit and risk balance compares with treatment alternatives.
When FDA believes that a drug's benefits no longer outweigh its risks,
the agency will ask the manufacturer to withdraw the drug.
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TYPES OF SAFETY ANNOUNCEMENTS
Early Communication About an Ongoing Safety Review:
This type of communication is part of FDA's effort to communicate early
with the public when the agency is still evaluating data and has not
reached a conclusion. FDA shares information in the interest of
informing doctors and patients about the issues that are under review
and when FDA experts anticipate completing their review.
Public Health Advisories:
These advisories provide important drug safety information and
recommendations of actions that can be taken by patients or caregivers
to avoid or minimize harm from a drug. They are issued when FDA has
information that would help doctors and patients make better treatment
choices. www.fda.gov/cder/news/pubpress.htm
Letters to Health Care Professionals:
These are letters—often referred to as "Dear Doctor" letters—that are
developed by drug companies often with input from FDA. The letters
educate health care professionals about new and important drug
information.
Information for Health Care Professionals:
Also referred to as a Healthcare Professional Information sheet, this
information from FDA is for doctors, pharmacists, nurses, and other
health care professionals. It contains an "alert" (a summary of the new
safety information), detailed information about the safety issue,
factors to consider when making treatment decisions, information for
health care professionals to discuss with patients about their roles in
reducing the risks from the drug, and a summary of the facts or data
that serve as the basis for the information in the sheet.
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FIND THE LATEST INFORMATION
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
Review, or other important information. www.fda.gov/cder/drug/drugsafety/DrugIndex.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 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.
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For More Information
FDA's Center for Drug Evaluation and Research
www.fda.gov/cder/index.html
FDA's Drug Safety Initiative
www.fda.gov/cder/drugSafety.htm
Date Posted: April 11, 2008
