Consumer Health Information
`www.fda.gov/consumer
`
`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.
`
`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.
`
` 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.
`
`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 effec-
`tiveness 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
`
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`Consumer Health Information
`www.fda.gov/consumer
`
`cause disability, are life-threatening,
`result in hospitalization or death, or
`are birth defects.
`
`TAKING MEDICATION
`
`
`
`Medication Guides
`Medication Guides are paper hand-
`outs/pamphlets that are required to
`be distributed to patients with cer-
`tain medications by the pharmacist.
`Medication Guides convey risk infor-
`mation 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 pre-
`scription drugs. CMI sheets are not
`available on the FDA Web site. The
`sheets help consumers understand
`key information about their prescrip-
`tion medicine, including how to take
`it, how to store it, and how to moni-
`tor 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 pre-
`scription 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 informa-
`tion from the clinical trials of the
`drug. Some prescription drug label-
`ing 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, informa-
`tion 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 sup-
`posed 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 seri-
`ous or life-threatening risks.
`
`MONITORING AFTER APPROVAL
`
`to health care professionals, including
`information on prescription and over-
`the-counter drugs, biologics, medi-
`cal devices, and special nutritional
`products. Health care professionals
`and consumers can also report seri-
`ous problems they suspect are related
`to certain FDA-regulated products.
`www.fda.gov/medwatch/safety.htm
`
`REMOVAL FROM THE MARKET
`
`Drug Recall
`A drug recall is an action taken by a
`firm to remove a product from the mar-
`ket 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 viola-
`tive product, will cause serious adverse
`health consequences or death. A drug
`may be recalled due to factors such as
`problems with packaging, manufactur-
`ing, or contamination.
`
`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.
`
`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 manufac-
`turer to withdraw the drug.
`
`FDA Adverse Event Reporting
`System (FAERS)
`FAERS 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 informa-
`tion and adverse event reporting
`program. It provides important and
`timely medical product information
`
`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.
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`Public Health Advisories
`These advisories provide important
`drug safety information and recom-
`mendations 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 devel-
`oped 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 Pro-
`fessional Information sheet, this
`information from FDA is for doc-
`tors, pharmacists, nurses, and other
`health care professionals. It contains
`an “alert” (a summary of the new
`safety information), detailed infor-
`mation 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.
`
`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 Informa-
`tion 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 informa-
`tion, 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 liv-
`ing 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 publish-
`ing 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 report-
`ing 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 informa-
`tion. 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
`
`Drug Product Recalls
`FDA provides information on drug
`products that have been recalled due
`to manufacturing problems and/or
`safety concerns. In addition to infor-
`mation 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.
`
`Patient Safety News
`This is a televised series for health
`care professionals, carried on sat-
`ellite broadcast networks aimed at
`hospitals and other medical facilities
`across the country. It features safety
`information on new drugs, biologics,
`and medical devices.
`www.accessdata.fda.gov/scripts/cdrh/
`cfdocs/psn/index.cfm
`
`Find this and other Consumer
`Updates at www.fda.gov/
`ForConsumers/ConsumerUpdates
`
` Sign up for free e-mail
`subscriptions at www.fda.gov/
`consumer/consumerenews.html
`
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