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Drugs and Medicines Information Resources

2008-03-29: We appreciate your patience while we organize our Drug Information page.

Drug Safety Background   ||   Drug Safety Definitions   ||   Drug Safety Background Reading
FDA Drug Information   ||   FDA Drug Safety and Adverse Events   ||   FDA MedWatch Online Complaint Form
FDA Children's Drugs   ||   FDA Medication Errors   ||   Complain About Problems in FDA-Regulated Clinical Trials
FDA Biologics and Vaccines   ||   Drug Interactions   ||   General Information (Non-FDA)
Patient Assistance Programs   ||   International Drug Safety Reporting   ||   Off Label: On Target or Off the Wall?

To be indexed:

FDA Postmarketing Study Database: http://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm

United States National Library of Medicine Specialized Information Services, Dietary Supplements Labels Database, U.S. Food & Drug Administration Actions: Recalls and Field Corrections Dietary Supplements (2002–): http://dietarysupplements.nlm.nih.gov/dietary/FDA2002.jsp (NB search by brands, active ingredients, and manufacturers)

There are several very important things to keep in mind about the information on this web page:

This information is not medical advice. CIRCARE officers and board members do not offer medical advice. Those CIRCARE officers or board members licensed to practice medicine are not offering you medical advice here. We firmly believe that medical decisions should be made by you and your primary care physician.

Don't make medical decisions based upon what you read here or anywhere else on the internet.

Don't stop, start, or change medicines without consulting a licensed physician.

The web sites in this section are either run by federal agencies (FDA) or professional healthcare associations, and identified as such. Following sections, e.g., General Information Resources, provide links to university and commercial information providers: identification and brief descriptions are included, generally in an explanation under the heading, and specifically with each link. Comments on utility, size of collection, or accessibility reflect nonprofessional opinion based on experience in use.

A useful glossary for terms used in drugs research is Bandolier's EBM Glossary. Bandolier will open in a new popup window so you can maintain your place on this page. If you'd prefer it didn't, follow this link instead: http://www.jr2.ox.ac.uk/bandolier/glossary.html You can also use the On-Line Medical Dictionary (search form at upper right of this page) or follow this URL to find a list of links to online glossaries of medical terminology.

United States Food and Drug Administration (FDA) General Drug Information

Contact Information FDA Division of Drug Information:

Telephone: 1-888 INFO-FDA; 1-888 463-6332 or (301) 827-4570
Correspondence: Division of Drug Information
5600 Fishers Lane, HFD-240
Rockville, MD 20857

The searchable drug information database Drugs@FDA is the most comprehensive information source. Each drug entry lists manufacturers, approval and labeling history, drug dosages and forms (IV, capsule, tablets, etc.), and in most cases provides a link to the Professional Prescribing Information (PPI), also confusingly enough called the Package Insert, or simply the Drug Label.

To find absolutely everything available from FDA, select Approval History and Related Documents and then select Review to access the Drug Approval Package. The Drug Approval Package contains FDA reviews of all the studies submitted for the drug's marketing application, together with biochemistry, pharmacology, statistics, and medical reviews. As you might expect, proprietary manufacturing information is redacted. Drug approval packages are not written for consumers and often exceed many hundreds of pages.

If the drug has been on the market for long enough there are likely to be generic drug approvals, which can make locating the original Drug Approval Package difficult. Start with the link with an NDA number or look for the drug identified as the RLD (Reference Listed Drug). Keep in mind that Professional Prescribing Information and Drug Approval Packages are less likely to be available for drugs that have been on the market for many years. You can write to the manufacturer and ask for a copy of the Professional Prescribing Information or ask your pharmacist or photocopy the relevant entry from the most recent edition of the Physician's Desk Reference, which is likely available in the reference section of your local public library. Drug Approval Packages can also be retrieved by making a request under the Freedom of Information Act. Follow this link for tips and suggestions on how and where to send FDA FOIA requests.

Though it's usually complete, on the chance that a Drug Approval Package hasn't been incorporated into the database, you can use the annual drug approval indices.


Adverse Events and Drug Safety Reporting

FDA collects safety information on marketed drugs through voluntary reports to the MedWatch system and by mandatory reporting from manufacturers, distributors, and clinical investigators.


FDA encourages MedWatch reports from both consumers and health professionals. Although the agency prefers that health professionals make these reports, essentially because they are more likely to use the reporting terms correctly, consumers should never feel as if they cannot or should not make MedWatch reports. Fill out the form as accurately as possible, and in the event you don't have one or more pieces of information, or cannot answer a specific question, just indicate this. Your report will go into the AERS database after examination by an FDA employee. If you want them to be able to contact you, provide the appropriate information in the MedWatch form, but keep in mind you may or may not be contacted.

The MedWatch system is voluntary: while we hope licensed healthcare professionals would report all data likely to help FDA evaluate marketed products, there is no requirement to report, either for them or for patients. This is very different from the mandatory reporting requirements imposed on drug and biologics manufacturers, distributors, packers, and sponsors and investigators with studies under IND.

If you're curious about the regulations that govern industry, look at the regulations for mandatory reporting:
Mandatory Reporting by Drug/Biologics Manufacturers, Distributors, and Packers and Studies under IND.

The AERS database functions like a sentinel system for the agency and others in the drug and healthcare industry.

On the one hand, FDA is relatively uninterested in AEs that are already known simply because the information is known and isn't terrifically useful. People might suppose FDA could calculate AE rates or the like, but without some way of knowing how many people take drug X or Y, there is no denominator with which to calculate anything. The difficulty is compounded by voluntary reporting: this means the available data is a small subset of the total and reported under uncontrolled conditions. For rate calculation to be meaningful, each AE would have to be analyzed to see whether or not it met the criteria for an ADR, since rates are, by definition, informative when based on a cause and effect relationship. If they got around this problem, an obvious one remains: how often something happens isn't the same as how likely something is to happen. People would arguably be interested in knowing how likely something is to happen, or the odds ratio for example, of experiencing a good outcome with a drug versus a bad outcome. Here again, we need cause and effect, but in addition we'd need a control group that wasn't taking the drug with which we could compare the group that was.

On the other hand, FDA and everyone else is interested in new unexpected AEs ; these get the lion's share of attention, and rightly so because if it's judged to be ADR, since it's new information, it wasn't considered in the risk-benefit assessment of one or more labeled indications, and it might turn out that the assessment needs to be reviewed or or the indications required modification. In some cases, the outcome leads to a change in the labeling. These assessments, along with ADRs reported by manufacturers, distributors, and packers, are published as Drug Safety Reports through the MedWatch system.

You can subscribe to an email list that will send you each MedWatch report published by FDA (which puts a lot of mail in your inbox, and which you may begin to ignore over time): http://www.fda.gov/medwatch/elist.htm

You can browse the archive (by date) or use the search form at the upper right of the Medwatch page: http://www.fda.gov/medwatch/safety.htm

FDA also maintains several specialized databases:

Human Liver Adverse Effects Database. (Not terrifically useful for non-professionals.)

Maximum Recommended Therapeutic Dose (MRTD) Database (For professionals.)

The email list is especially useful for keeping track of information sections on the FDA web site during upgrades and re-organization, as has been the case (to the agency's credit) over the past two years.

Complaints About FDA-Approved Drugs: MedWatch

Strange as it seems, few consumers seem to know how or when to complain to FDA. Consumers (yes, people without medical training … ) can report adverse events and problems with medical devices, drugs, dietary supplements, and vaccines.

How to Complain About FDA-Regulated Drugs, Medical Devices, and Dietary Supplements: http://www.circare.org/info/productcomplaint.htm

FDA Adverse Event Reporting System (AERS)

To obtain the FDA Quarterly Data Extract from the Adverse Event Reporting System (AERS): go to the National Technical Information Service (NTIS) Search page at: http://www.ntis.gov/search/index.asp?loc=3-0-0, and enter AERS as the search term.

Update 2005-02-03: although AERS data is still distributed as described above, FDA has posted recent quarterly AERS data on their web site at: http://www.fda.gov/cder/aers/extract.htm. Quarterly data files for the periods April 2004 to the present are available for downloading in ASCII or SGML formats. Keep in mind these are enormous files and must be imported into a database. Attempting to open files of this size with a text program like NotePad or TextEdit is suicidal and will probably crash your computer.

If you're looking for information on adverse drug reactions, this data is not the most sensible way to find it. The cost is relatively high: to access this data, you're required to purchase an annual subscription for $495, and then you must supply your own database program to organize and search the data. While FDA redacts identifying personal medical information, they do no other editing. Since there is no restriction on who can file a MedWatch Report or what information they can file, AERS data is anything but indicative of cause and effect relationships, meaning the data cannot be interpreted as ADRs without evaluation.

Before an AE can be interpreted as an ADR, it needs to be tracked down, investigated, and judged by professionals. What's more, these professionals need to use standardized reporting terms consistently. These reports, and ADRs in general, can be found in a number of ways. Drug safety publications follow below this list.

Drug Safety Publications

FDA Medical Bulletin

Before the advent of the internet, FDA published an outstanding periodical to keep the medical community up to date on drug safety and other developments.

In the UK, drug safety information from the Medicines and Healthcare products Regulatory Agency is published in:

Monitoring safety and quality of medicines: Current Problems in Pharmacovigilance. Available from http://medicines.mhra.gov.uk/ourwork/monitorsafequalmed/currentproblems/currentproblems.htm

Mandatory Reporting Requirements for Industry

If you're curious about the regulations that govern industry, look at the regulations for mandatory reporting:

Mandatory Reporting by Drug/Biologics Manufacturers, Distributors, and Packers and Studies under IND. Available from http://www.fda.gov/medwatch/report/mfg.htm

International Drug Safety Programs

People in the United Kingdom can try out the new Yellow Card system online, which accepts AE and ADR reports from both professionals and consumers:
URL: http://www.yellowcard.gov.uk/

Canada: Canadian Adverse Drug Reaction Monitoring Program (CADRMP) (Information and Terms of Use; link to the online query is at the bottom of the page.) Available from http://www.hc-sc.gc.ca/dhp-mps/medeff/databasdon/agreement_accord_e.html

Off Label Drug Use

Many drugs are prescribed for so-called off label uses, and this can be a source of great confusion for consumers. One reason many drugs are prescribed off label is a direct result of the way in which drugs are approved. In order to market a drug in the US, FDA requires the manufacturer to provide competent scientific evidence that the drug is safe and effective for the claimed indication(s) for use. Practically speaking, this means data from clinical trials. If or when the drug is approved for marketing, the illness or disorder for which the drug was tested becomes the indicated use on the label. Once a drug has marketing approval, however, FDA does not regulate the uses for which it can be prescribed by physicians. Off label use requires the physician to base his or her recommendation on sound medical judgment and reliable evidence that the drug is likely to work as intended for the patient.

Good evidence exists for a number of off label indications while evidence is absent or equivocal in other instances. For this reason, it's difficult for patients to evaluate off label use. We hold physicians responsible for their judgment, and we expect them to keep up with the literature, obtain Continuing Medical Education (CME) credits, and otherwise know what they're doing. Nearly all state medical practice acts require licensees to document a specified number of CME credits over a one or two-year period. While this is all to the good, Continuing Medical Education programs are subject to voluntary regulation through the Accreditation Council for Continuing Medical Education (ACCME). This organization has come under fire for fussing over pedagogical issues while giving short shrift to content. The fact that it was not until quite recently that ACCME began to require CME courses demonstrate scientific validity suggests past criticism may have had merit.

People often wonder why some drug indications are not on the label if there is clinical trial data suggesting or demonstrating safety and efficacy. The answer is complicated but economic interest plays an important part. Even if clinical trial data exists, if the drug's patent has expired, manufacturers aren't terribly motivated to spend the money for a New Drug Application (necessary to change the indications on the label) if, once they've been granted the new indication, all their competitors producing the same drug can immediately receive (expected) increased revenue without spending a dime. In the cases in which clinical trial data exists, such data may not meet FDA's requirements, which tend to be specific to the class of drug and disease or disorder.

Off label is confusing precisely because is says nothing.

  1. It doesn't mean a given usage is not approved because this implies such usage in the practice of medicine requires approval. It doesn't.
  2. It doesn't mean a given usage is experimental because there may or may not be data to support a given use.
  3. It does mean just what it says: the usage isn't included among the indications on the drug's label.

Prescribing drugs off label has advantages and disadvantages. If you're concerned about an off label prescription, ask your physician to explain why they prescribed the drug. More information about the off label use of drugs is available below.

Pediatric Drugs

In 2002, the Best Pharmaceuticals for Children Act became law. The law was designed to increase information on drug safety and efficacy in children, which is often lacking because most drugs get marketing approval based upon clinical trials on adults. In typical fashion, the act follows the carrot-and-stick approach: it offers drug manufacturers an extra six months of patent exclusivity if they conduct pediatric trials, and it simultaneously gives FDA a bit more leeway, namely the authority to request certain manufacturers conduct pediatric studies, and the right to disclose the results of studies conducted under the BPCA. All the agency evaluations of the studies concluded to date are available below.

Miscellaneous FDA Information Resources

FDA / CDER Online Training

These are aimed at professionals but consumers may find them useful nonetheless.

Dietary Supplements

FDA/CFSAN Special Nutritionals Adverse Event Monitoring System (SN/AEMS) Web Report. 1998-10-20. Available from http://web.archive.org/web/20020605235541/vm.cfsan.fda.gov/~dms/aemsfull.html

FDA/CFSAN Special Nutritionals Adverse Event Monitoring System (SN/AEMS) Main Page. Available from http://web.archive.org/web/20020607140541/http://vm.cfsan.fda.gov/~dms/aems.html

U. S. Food and Drug Administration Center for Food Safety and Applied Nutrition. Economic Characterization of the Dietary Supplement Industry Final Report. March, 1999. Available from http://www.cfsan.fda.gov/~comm/ds-econt.html. Accessed 2006-02-03.

FDA Resources on Medication Errors

Keep publication dates in mind because reporting regulations change over time. These may be of historical interest only.

Get Information or Complain About Clinical Research With FDA-Regulated Products


Biologics / Vaccines

FDA Vaccine Adverse Event Report System (Search the on-line database for Vaccine Adverse Event Reports and find information on vaccines.)

Post-marketing surveillance for adverse events after vaccination: the national Vaccine Adverse Event Reporting System. FDA Center for Biologics Evaluation and Research (CBER). http://www.fda.gov/medwatch/articles/vaers/vaersce.pdf

Additional Drug Information Resources

The resources that follow are not sponsored by federal agencies so we've identified them and included some idea of what to expect.

Caution: both of the following sites offer Patient Information Literature (PIL). These sheets are designed to overcome the difficulties consumers experience when attempting to extract meaningful information from the Professional Prescribing Insert. It goes without saying this is a great idea. The contents of these information sheets, however, is not subject to FDA approval, and the quality of information depends upon the information provider. The choice of information provider can vary between one location and another because pharmacists and pharmacies are regulated by state laws. Your first choice for Patient Information Literature should be the FDA (see above, FDA Consumer Drug Information Sheets); if FDA hasn't produced Patient Information Literature on the drug prescribed for you, it might be wise to double-check non-FDA Patient Information Literature against the drug's Professional Prescribing Insert, in particular the Contraindications and Indications for Use sections.

Drugs.com (Commercial provider with information for consumers and professionals. Provides FDA-approved Professional Prescribing Information in most cases. Ads.)

Mosby's Drug Consult & Top 200 Drugs (The free section of a subscription-only professional drug information database; includes patient information and FDA-approved Professional Prescribing Information. No ads and lots of information.)

RxList.com (Commercial provider with professional and consumer information. Provides FDA-approved Professional Prescribing Information for most drugs. Ads.)


About: The DrugBank database is a unique bioinformatics and cheminformatics resource that combines detailed drug (i.e. chemical, pharmacological and pharmaceutical) data with comprehensive drug target (i.e. sequence, structure, and pathway) information. The database contains nearly 4300 drug entries including >1,000 FDA-approved small molecule drugs, 113 FDA-approved biotech (protein/peptide) drugs, 62 nutraceuticals and >3,000 experimental drugs. Additionally, more than 6,000 protein (i.e. drug target) sequences are linked to these drug entries. Each DrugCard entry contains more than 80 data fields with half of the information being devoted to drug/chemical data and the other half devoted to drug target or protein data.

Drug Interactions

Drug Interaction Checker. (MicroMedex. Published by Thomson Scientific.)

Cytochrome P450 AKA Flockhart. Indiana University Department of Pharmacology Web-Based Educational Tools (Targeted toward professionals seeking information on drug metabolism in the liver; limited narrative.)

Cytochrome P450 at the University of Colorado Health Sciences Center. (Targeted toward professionals seeking information on drug metabolism in the liver; includes narrative discussion.)

Be extremely cautious about the drug interaction web site run by The Center for Food-Drug Interaction Research and Education at: http://www.druginteractioncenter.org/

The Center for Food-Drug Interaction Research and Education is a collaborative project of academic researchers from Tufts University and the University of Florida, and apparently funded by the Florida Department of Citrus, the otherwise fine people who bring us Florida oranges and grapefruit.

Grapefruit juice (which many people adore) shares the same important metabolic pathway in the liver with a number of drugs. Grapefruit juice can, in some cases, significantly increase or decrease the rate at which these drugs are metabolized, and ultimately influence the amount of the drug (s) in the bloodstream. This can be minor or very serious indeed. As you might imagine this interaction has important financial implications for the citrus industry. The center's research program in grapefruit–drug interactions, however, might strike some people as baffling if they believe the welfare of the public is more important than the welfare of the grapefruit industry.


Center-supported basic and clinical research will address current needs, as well as anticipate longer-range problems and issues. Initial research and educational activities will focus on drug interactions with grapefruit juice and grapefruit. Recognizing that as research begins to define the grapefruit/drug interaction, the Center may move into other food-drug interactions. The immediate tasks of the Center are to develop an overall scientific strategy for exploring the grapefruit/drug interaction phenomena, to establish prioritized areas of research and initiate research efforts. The strategy and resulting research should deal with the issue in a manner that considers both the welfare of the public and the grapefruit industry.

Accessed 2005-01-31 from

Read all the fiddly warning stickers on prescription bottles and always check with your physician or pharmacist if you have questions or concerns. This is a partial list of drugs with which grapefruit juice interacts. Do not rely on this list as it is surely incomplete. Always consult with the prescribing physician.

Source: References for Cytochrome P450 Drug Interaction Table. Part 7 of 7: 3A4,5,7 Isoforms. Accessed 2005-01-31 from: http://medicine.iupui.edu/flockhart/3A457.htm#62grapefruit

Ancillary Information Resources

Consumers are often interested in acquiring some of the skills involved in evaluating published trial results for which some of following resources may be useful.

Summary Statistics For Dichotomous Outcome Data. Cochrane Collaboration Open Learning Material. (Good explanations of risk, odds ratio, and number needed to treat.)

HyperStat Online Textbook. © 1993-2003 David M. Lane

Statistics At Square One. 9th Ed. T. D. V. Swinscow. Revised by M J Campbell University of Southampton. Copyright BMJ Publishing Group 1997

Statistical Evidence. Steve Simon Ph.D (Draft chapters of Statistical Evidence forthcoming from Oxford University Press.


Free or Low-Cost Drug Programs

These web sites provide information about various drug manufacturers' Patient Assistance Programs which supply drugs at low or no cost to patients meeting specific financial qualifications.



Off Label Drug Use Continued

FDA offers little guidance on off label use of prescription drugs but this shouldn't surprise anyone. FDA regulations prohibit promotion of off label indications and it's unlikely the agency would serve as a resource on what it prohibits (sponsors and manufacturers are permitted to provide information about off label indications to physicians at professional meetings). Moreover the term off label is generally applied to the practice of medicine, which FDA does not regulate. This causes confusion if people don't understand the term or the term is mis-applied or otherwise misrepresented. Extracts from a single page article (No.1 below) get trotted out every so often to defend the propriety of physicians' use of drugs for off label indications, but rarely, if ever, is the full article available. Therefore we retrieved the relevant issue of the FDA Drug Bulletin and posted it on our web site.

Item no. 2 clarifies that not every drug can be prescribed for off label indications. Item no. 3 is written by FDA to help clinical investigators distinguish between research and medical practice. Item no. 4 is an extensive professional review of off label use as it pertains to informed consent in the practice of medicine and to medical malpractice litigation.

Item no. 5 is FDA testimony before the Senate Committee on Labor and Human Resources on the promotion of off label uses for marketed drugs. The testimony is instructive because it shows the agency's thinking about the risks and benefits of off label prescribing.

1. US Food and Drug Administration. Use of approved drugs for unlabeled indications. FDA Drug Bulletin. 1982;12(1):4-5. Available from http://www.bioethicswatch.org/pubs/FDA_MedBull.pdf. Accessibility verified 2006-01-14.

Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgment. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects. Use of a marketed product in this manner when the intent is the practice of medicine does not require the submission of an Investigational New Drug Application (IND), Investigational Device Exemption (IDE) or review by an Institutional Review Board (IRB). However, the institution at which the product will be used may, under its own authority, require IRB review or other institutional oversight.

2. Perls TT, Reisman NR, Olshansky SJ. Provision or Distribution of Growth Hormone for Antiaging. Clinical and Legal Issues. JAMA. 2005;294:2086-2090. Available from http://jama.ama-assn.org/cgi/content/extract/294/16/2086 . Accessibility verified 2006-01-14.

3. US Food and Drug Administration. Off-Label and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices. INFORMATION SHEETS Guidance for Institutional Review Boards and Clinical Investigators. 1998 Update. Available from http://www.fda.gov/oc/ohrt/irbs/offlabel.html. Accessibility verified 2004-08-28.

4. Beck JM, Azari E. FDA, Off-Label Use, and Informed Consent: Debunking Myths and Misconceptions. Food and Drug Law Journal. 2001;53:71-104. Available from http://web.archive.org/web/20040623021551/http://library.lp.findlaw.com/articles/00081/001502.pdf. Accessibility verified 2006-01-14.

5. Testimony of William B Schultz Deputy Commissioner for Policy, Food and Drug Administration, Public Health Service, U.S. Department of Health and Human Services, before the Senate Committee on Labor and Human Resources. Unapproved Uses of Prescription Drugs. Available from http://www.os.hhs.gov/asl/testify/t960222a.html. 1996-02-22.


Background Reading on Drug Adverse Events

Bandolier, an independent journal about evidence-based healthcare, written by scientists at Oxford University, offers several short intelligible articles on adverse events.

Understanding risk. Bandolier. October 2004; 128–6. Available from http://www.jr2.ox.ac.uk/bandolier/band128/b128-6.html

When things go wrong. Bandolier. June 1996; 28–1. Available from http://www.jr2.ox.ac.uk/bandolier/band28/b28-1.html

This article defines terms used in reporting adverse drug events and provides examples:

Nebeker JR, Barach P, Samore MH. Clarifying Adverse Drug Events: A Clinician's Guide to Terminology, Documentation, and Reporting. Ann Internal Med. 2004;140:795-801. Available from http://www.annals.org/cgi/reprint/140/10/795.pdf

This comprehensive bibliography includes links to many full-text articles and reports:

Patient Safety Bibliography. National Patient Safety Foundation and AHRQ. (2002-2005). Available from http://npsf.disted.mcw.edu/InfoCenter/Glossary/bibliography.asp


Drug Adverse Event Reporting Definitions

Table 1: Adverse Drug Event Reporting Terms

Term Definition

Adverse Event

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Source: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. (ICH-E2A March 1995). Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. P. 2. Accessed 2005-01-16 from: http://www.fda.gov/cder/guidance/iche2a.pdf

Adverse Drug Reaction

A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function.

Source: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. (ICH-E2A March 1995). Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. P. 3. Accessed 2005-01-16 from: http://www.fda.gov/cder/guidance/iche2a.pdf

A Useful Explanation of ADRs:

What is an adverse drug reaction?

An adverse drug reaction (ADR) is an unwanted or harmful reaction experienced following the administration of a drug or combination of drugs and is suspected to be related to the drug. The reaction may be a known side effect of the drug or it may be a new previously unrecognized ADR.

What is the difference between an adverse drug reaction and an adverse event?

Very often the terms adverse reaction and adverse event are used synonymously. This is not always correct. An adverse event is any undesirable experience that has happened to the patient while taking a drug but may or may not be related to the drug. An adverse event is not always the same as an adverse drug reaction as adverse events encompass ADRs but may also include cases where no association has been or can be made between drug administration and the adverse event experienced. An example of an adverse event is a patient being hit by a car while on a specific medication while an ADR could be a patient experiencing anaphylaxis shortly after taking the drug.

Source: Committee on Safety of Medicines. Medicines and Healthcare Products Regulatory Agency. Accessed 2005-01-17 from: http://www.yellowcard.gov.uk/adversereactions.htm

Adverse Drug Experience (FDA)

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; and any failure of expected pharmacological action.

Source: 21 CFR 310.305 (b). Accessed 2005-01-16 from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=310.305

Disability (FDA)

A substantial disruption of a person`s ability to conduct normal life functions.

Source: 21 CFR 310.305 (b). Accessed 2005-01-16 from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=310.305

Life-threatening adverse drug experience (FDA)

Any adverse drug experience that places the patient, in the view of the initial reporter, at immediate risk of death from the adverse drug experience as it occurred, i.e., it does not include an adverse drug experience that, had it occurred in a more severe form, might have caused death.

Source: 21 CFR 310.305 (b). Accessed 2005-01-16 from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=310.305

Serious adverse drug experience (FDA)

Any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.

Source: 21 CFR 310.305 (b). Accessed 2005-01-16 from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=310.305

Unexpected adverse drug experience (FDA)

Any adverse drug experience that is not listed in the current labeling for the drug product. This includes events that may be symptomatically and pathophysiologically related to an event listed in the labeling, but differ from the event because of greater severity or specificity. For example, under this definition, hepatic necrosis would be unexpected (by virtue of greater severity) if the labeling only referred to elevated hepatic enzymes or hepatitis. Similarly, cerebral thromboembolism and cerebral vasculitis would be unexpected (by virtue of greater specificity) if the labeling only listed cerebral vascular accidents. Unexpected, as used in this definition, refers to an adverse drug experience that has not been previously observed (i.e., included in the labeling) rather than from the perspective of such experience not being anticipated from the pharmacological properties of the pharmaceutical product.

Source: 21 CFR 310.305(b). Accessed 2005-01-16 from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=310.305

Side Effect

A usually predictable or dose-dependent effect of a drug that is not the principal effect for which the drug was chosen; the side effect may be desirable, undesirable, or inconsequential.

Source: Cobert BL, Biron P. Pharmacovigilance from A to Z. Malden, MA: Blackwell Science; 2002.

Statistical Significance

Table 3: EU Verbal Descriptors of Harm

EU verbal descriptors of side effect probability
Very common
over 10%
more than 1 in 10
1 in 100 to 1 in 10
1 in 1,000 to 1 in 100
1 in 10,000 to 1 in 1,000
Very rare
less than 0.01%
less than 1 in 10,000

Collected Information By Drug

Human Growth Hormone (HGH)

Perls TT. Anti-Aging Quackery: Human Growth Hormone and Tricks of the Trade More Dangerous Than Ever. Journal of Gerontology: Biological Sciences. 2004;59A(7):682-691. Available from http://www.bumc.bu.edu/www/BUSM/Cen/articles/antiagingquackery.pdf

Hormone Replacement Therapy (HRT). FDA has put together several informational web pages for women considering or using replacement hormone treatment, including summaries of clinical trials, links to published studies, a list of approved drugs with Professional Prescribing Information, and links to find additional sources of reliable information at: http://www.fda.gov/bbs/topics/news/2004/NEW01121.html (Posted on 2004-10-04.)

Also useful is the recent NIH Consensus Statement on menopause:

NIH State-of-the-Science Conference on Management of Menopause-Related Symptoms. 2005-03-23. Available from http://consensus.nih.gov/2005/2005MenopausalSymptomsSOS025PDF.pdf
NIH State-of-the-Science Conference on Management of Menopause-Related Symptoms Program and Abstract Book. 2005-03-23. Available from http://consensus.nih.gov/2005/2005MenopausalSymptomsSOS025Program.pdf

Agency for Healthcare Research and Quality. AHRQ Review: Management of Menopause-Related Symptoms. 2005-03. Available from http://www.ahrq.gov/clinic/tp/menopstp.htm

Bio-Identical Hormones

Boothby LA, Doering PL, Kipersztok S. Bioidentical hormone therapy: a review. Menopause. 2004;11(3):356-67.

(Abstract) OBJECTIVE: The terms natural or bioidentical hormone therapy (NHT) are used to describe hormone treatment with individually compounded recipes of certain steroids in various dosage forms, including dehydroepiandrosterone, pregnenolone, testosterone, progesterone, estrone, estradiol, and estriol. Based on the results of a person's salivary hormone levels, the final composition of the compounded dosage form is individualized to that specific person. Proponents claim that NHT is better tolerated than manufactured products. This paper is intended to review the concept of NHT and to determine whether there is sufficient scientific evidence to support its use. DESIGN: A literature search was performed in Medline using the following MeSH terms and key words: drug combinations; progestational hormones; hormone replacement therapy; endometrium; estrogen replacement therapy; climacteric; menopause; estradiol; estrogens; progesterone; drug monitoring; and drug compounding. Current Contents, International Pharmaceutical Abstracts, Cochrane Database of Systematic Reviews, Lexis Nexis, Google, Medscape, MD Consult, and clinicaltrials.gov were searched with key words. RESULTS: There are a few observational studies and clinical trials comparing conventional hormone therapy with bioidentical hormone therapy. Studies generally lacked adequate study design, including small sample sizes and comparison of inequivalent doses, to prove safety and efficacy. Little evidence was found to support individualized hormone dosing based upon saliva hormone concentrations. CONCLUSION: Evidence suggests that, although individualized hormonal products may decrease some symptoms of menopause, it seems they have no proven advantage over conventional hormone therapies and their use is not supported by evidence regarding pharmacokinetics, safety, and efficacy.

Accessed on 2005-10-26 from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15167316&query_hl=1

Women to whom so called Bioidentical Hormones have been recommended may wish to read the testimony of Adrian Fugh-Berman M.D. before making up their minds.

Balancing Act: The Health Advantages of Naturally Occurring Hormones in Hormone Replacement Therapy. Testimony of Adrian Fugh-Berman M.D. Associate Professor Georgetown University School of Medicine. Before the House Committee on Government Reform Subcommittee on Wellness and Human Rights. 2004-07-22. Available from http://reform.house.gov/UploadedFiles/gtown%20testimony.pdf

FDA-Approved Anti-Virals for the Treatment of HIV/AIDS
FDA Office of Special Health Issues HIV/AIDS Resources

FDA Office of Special Health Issues Cancer Liaison Program

NIH Public Thalidomide Meeting (1997-09-09)
NIH Public Thalidomide Meeting (1997-09-10)

Background Information or Food For Thought on Drug Safety Information

Coming soon :)


Last Updated: 2008-03-29

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