MEDICAL: PHARMACY PHARMACEUTICAL PHARMACOLOGY: DRUG: SIDE EFFECTS : BIBLIOGRAPHIES : WEBLIOGRAPHIES: Prescription Drugs Side Effects and Adverse Events: Selected Sources

[David P. Dillard]

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MEDICAL: PHARMACY PHARMACEUTICAL PHARMACOLOGY: DRUG: SIDE EFFECTS :
BIBLIOGRAPHIES :
WEBLIOGRAPHIES:
Prescription Drugs Side Effects and Adverse Events: Selected Sources

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WEBBIB1011

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Prescription Drugs Side Effects and Adverse Events: Selected Sources

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WEBBIB1011

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MedWatch:
The FDA Safety Information and Adverse Event Reporting Program
Home > Safety > MedWatch
The FDA Safety Information and Adverse Event Reporting Program
United States. Food and Drug Administration
http://www.fda.gov/Safety/MedWatch/default.htm

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Worst Pills / Best Pills
http://www.worstpills.org/public/page.cfm?op_id=4
"Although some adverse drug reactions (ADR) are not very serious, others
cause the death, hospitalization, or serious injury of more than 2 million
people in the United States each year, including more than 100,000
fatalities. In fact, adverse drug reactions are one of the leading causes
of death in the United States.1 Most of the time, these dangerous events
could and should have been avoided. Even the less drastic reactions, such
as change in mood, loss of appetite, and nausea, may seriously diminish
the quality of life."
This is a searchable database of information regarding specific drugs.

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Drug Reactions
Family Doctor.org
http://familydoctor.org/online/famdocen/home/seniors/seniors-meds/231.html

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Are prescription drugs safe? Not necessarily
Last reviewed: November 2009
Consumer Reports
http://www.consumerreports.org/health/best-buy-drugs/
drug-safety-overview/overview/drug-safety-overview-ov.htm

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A shorter URL for the above link:

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http://tinyurl.com/yj684ta

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Safety Issues with Herbal Medicine:
Approaches to Adverse Effects
Medscape Today
http://www.medscape.com/viewarticle/409518_5

"All medicinal agents have potentially unexpected effects including
toxicity, and herbals are no different. As with other drugs, the risk of
unexpected effects may be influenced by a user's age, gender, genetics,
nutrition status, and concurrent disease states and treatments. Unexpected
effects of herbal medicines may be classified as intrinsic or extrinsic to
the compound.[31]

Intrinsic effects are due to inherent phyto-chemicals in the given
product, such as predictable dose-related toxicity and interactions, as
well as idiosyncratic reactions.[31] Predictable, dose-dependent adverse
effects are easier to identify than idiosyncratic reactions but are poorly
documented."

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Drugs.com
http://www.drugs.com/

Articles regarding specific drugs.
Searchable database provides this content sample for a search of the word
adverse:

adverse event definition
Definition of adverse event. Provided by Stedman's medical dictionary and
Drugs.com. Includes medical terms and definitions.
Medical Dictionary (Stedman's)

adverse drug event definition
Definition of adverse drug event. Provided by Stedman's medical dictionary
and Drugs.com. Includes medical terms and definitions.
Medical Dictionary (Stedman's)

Clinical Trials: Depomed's Gralise Shown To Have Similar Efficacy and
Adverse Event ...
Depomed's Gralise Shown To Have Similar Efficacy and Adverse Event
Profiles in Patients At Least 65 Years Old Compared With Patients Overall

Clinical Trial Results (FDA)
FDA Alert: Yervoy (ipilimumab): Risk Evaluation and Mitigation ...
Yervoy (ipilimumab): Risk Evaluation and Mitigation Strategy (REMS) -
Severe Immune-Mediated Adverse Reactions

Drug Alerts (FDA)
Pravastatin Prescribing Information
Generic Name: Pravastatin sodium Dosage Form: tablet Pravastatin Sodium
Tablets Rx only Pravastatin Description Pravastatin sodium tablets are one
of a class of lipid-lowering compounds, the HMG-CoA reductase inhibitors,
which reduce cholesterol biosynthesis. These agents are competitive
inhibitors of...
Professional Monograph (FDA)

A-Z Drug Facts (Facts & Comparisons) Professional Information (A-Z Drug
Facts)
A-Z Drug Facts for the Professional. A-Z Drug Facts for the professional
provided by Wolters Kluwer Health. Search A-Z Drug Facts for the
Professional
A-Z Drug Facts (Facts & Comparisons)

Sodium Sulfate Information
Sodium Sulfate information from Drugs.com, includes Sodium Sulfate side
effects, interactions, indications
Professional Information (Drugs.com)

Contraceptives, Oral (Combination Products) ... Professional Information
(A-Z Drug Facts)
Pronunciation: (kan-tra-SEP-tiv) Class: Hormone, Contraceptive Trade
Names: Apri - Tablets ethinyl estradiol 30 mcg/desogestrel 0.15 mg Trade
Names: Aranelle - Tablets ethinyl estradiol 35 mcg/norethindrone 0.5 mg
Trade Names: Aviane - Tablets ethinyl estradiol 20 mcg/levonorgestrel 0.1
mg Trade Names:...
A-Z Drug Facts (Facts & Comparisons)

Adverse reactions to stopping Lexapro?
1 Answer - Posted in: lexapro, weight - Answer: It is very common to have
all of the side effects that you've listed off. ...
Drugs Questions & Answers (Drugs.com)

Clinical Trials: Increased SVR and Decreased Adverse Events Reported in
Final ...
Presented Tuesday, 2 November 2010, 8 00 am The Phase 3 results from the
ADVANCE study confirm the clinical benefits of telaprevir-based
combination therapy reg
Clinical Trial Results (FDA)

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RX List
http://www.rxlist.com/script/main/hp.asp
Articles regarding specific drugs and a searchable database of drug
information.

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Adverse Drug Experience Reporting
United States Food and Drug Administration
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm082056.htm

On December 23, 2007 a significant change to the postmarketing reporting
requirements for drug products goes into effect. Chapter VII, SubChapter
H, Section 760 of the Food, Drug, and Cosmetic (FD&C) Act establishes new
adverse event reporting requirements which apply to the manufacturers,
packers, and distributors whose names appear on the labels of
over-the-counter (OTC) or behind-the-counter (BTC) drugs marketed in the
United States. Please see links below for reference documents related to
these new requirements.

To ensure consumer safety, the FDA collects information on adverse drug
experiences that occur after a prescription medication is approved or
marketed. The Division of Compliance Risk Management and Surveillance
enforces the Postmarketing Adverse Drug Experience (PADE) Reporting
Requirements in an effort to ensure that the FDA is receiving data on
rare, latent, or long-term drug effects not identified in premarket
testing. The division also ensures that PADE reports are accurate,
complete, and submitted in a timely manner. The division communicates the
agency's compliance expectations to the pharmaceutical industry through
outreach efforts, including presentations to various industry associations
and agency counterparts and training sessions at the FDA's Basic Drug
School for investigators.

Drug firms, health care professionals, and consumers submit PADE reports
to FDA for domestic and foreign adverse events associated with
FDA-regulated drug products. Based on these reports, the division
identifies domestic and foreign firms, including New Drug Application
holders and drug manufacturers, packers, and private-label distributors,
for inspection. The division uses a risk-based approach to identify firms
for inspection that focuses on drugs that pose a significant health risk
to consumers and other priority issues affecting the public's health. The
findings of the inspections are evaluated to determine if regulatory
action is necessary.

Drug application holders and certain manufacturers, packers, and
distributors for prescription and non-prescription drugs are required to
submit specific adverse event and drug safety information to FDA. These
requirements are set forth in the Federal Food, Drug, and Cosmetic Act
(FD&C Act) and Title 21 of the Code of Federal Regulations (CFR). Final
and draft guidances are available which clarify the FDA's expectations for
meeting the regulatory requirements.

Related Resources

Dietary Supplement and Non-prescription Drug Consumer Protection Act1. The
legislation establishing the new requirements for reporting adverse events
associated with the use of dietary supplements and non-prescription (OTC)
drug products.

Postmarketing Adverse Event Reporting for Nonprescription Human Drug
Products Marketed without an Approved Application (PDF - 66KB)2. The draft
guidance clarifying how to submit reports of serious adverse events
associated with unapproved over the counter drug products.

Adverse Event Reporting System web site3. The Adverse Event Reporting
System (AERS) is a computerized information database designed to support
the FDA's post-marketing safety surveillance program for all approved drug
and therapeutic biologic products.

AERS Electronic System for Submitting Adverse Drug Reaction Reports4. This
site provides information on submitting AERS reports using electronic
files, not paper report forms.

MedWatch Site - Mandatory Reporting by Manufacturers, Packers, and
Distributors5. This site provides reporting forms and instructions,
applicable regulations, and guidance for industry and Agency field staff
for MedWatch, the FDA's Safety Information and Adverse Event Reporting
Program.

CFR Part 310, Sec. 310.305 - Records and Reports Concerning Adverse Drug
Experiences6. Links to the applicable section of the Code of Federal
Regulations regarding records and reports concerning adverse drug
experiences on marketed prescription drugs for human use without approved
new drug applications.

CFR Part 310, Sec. 314.80 - Postmarketing Reporting of Adverse Drug
Experiences [Products with NDA approvals]7. Links to the applicable
section of the Code of Federal Regulations regarding postmarketing
reporting of adverse drug experiences, including definitions and
submission and review of reports.

CFR Part 310, Sec. 314.98 - Postmarketing Reporting of Adverse Drug
Experiences [Products with A(NDA) approvals]8. Links to the applicable
section of the Code of Federal Regulations regarding postmarketing
reporting for drug products with abbreviated new drug approvals (A(NDA)s).

CFR Part 310, Sec. 314.81 - Other Postmarketing Reports9. Links to the
applicable section of the Code of Federal Regulations regarding other
postmarketing reports, including the Annual Report.

CFR Part 211, Sec. 211.198 - Complaint Files10. Links to the applicable
section of the Code of Federal Regulations regarding written and oral
complaints about a drug product.

CFR Part 310, Sec. 314.90 - Waivers11. Links to the applicable section of
the Code of Federal Regulations regarding obaining a waiver from the CDER
Office of Surveillance and Epidemiology for postmarketing reporting
requirements.

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Drug Saf. 2008;31(12):1083-96. doi: 10.2165/0002018-200831120-00005.
Long-term consequences of drugs on the paediatric cardiovascular system.
Hausner E, Fiszman ML, Hanig J, Harlow P, Zornberg G, Sobel S.
Source Food and Drug Administration, Silver Spring, Maryland, USA.
http://www.ncbi.nlm.nih.gov/pubmed/19026026

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Adverse Reaction Database
Canada Vigilance Adverse Reaction Online Database
http://www.hc-sc.gc.ca/dhp-mps/medeff/databasdon/index-eng.php

"The Canada Vigilance Adverse Reaction Online Database contains
information about suspected adverse reactions (also known as side effects)
to health products, captured from adverse reaction reports submitted to
Health Canada by consumers and health professionals, who submit reports
voluntarily, as well as by market authorization holders (manufacturers and
distributors), who are required to submit reports according to the Food
and Drugs Regulations. Information concerning vaccines used for
immunization is provided in the Vaccine Safety section of the Public
Health Agency of Canada Web site."

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NIDA InfoFacts:
Prescription and Over-the-Counter Medications
The National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)
U.S. Department of Health and Human Services.
http://www.drugabuse.gov/infofacts/PainMed.html

Prescription medications such as pain relievers, central nervous system
(CNS) depressants (tranquilizers and sedatives), and stimulants are highly
beneficial treatments for a variety of health conditions. Pain relievers
enable individuals with chronic pain to lead productive lives;
tranquilizers can reduce anxiety and help patients with sleep disorders;
and stimulants help people with attention-deficit hyperactivity disorder
(ADHD) focus their attention. Most people who take prescription
medications use them responsibly. But when abused-that is, taken by
someone other than the patient for whom the medication was prescribed, or
taken in a manner or dosage other than what was prescribed-prescription
medications can produce serious adverse health effects, including
addiction.

Patients, health care professionals, and pharmacists all have roles in
preventing the abuse1 of and addiction to prescription medications. For
example, patients should follow the directions for use carefully; learn
what effects and side effects the medication could have; and inform their
doctor/pharmacist whether they are taking other medications [including
over-the-counter (OTC) medications or health supplements], since these
could potentially interact with the prescribed medication. The patient
should read all information provided by the pharmacist. Physicians and
other health care providers should screen for past or current substance
abuse in the patient during routine examination, including asking
questions about what other medications the patient is taking and why.
Providers should note any rapid increases in the amount of a medication
needed or frequent requests for refills before the quantity prescribed
should have been finished, as these may be indicators of abuse.1

Similarly, some OTC medications, such as cough and cold medicines
containing dextromethorphan, have beneficial effects when taken as
recommended; but they can also be abused and lead to serious adverse
health consequences. Parents should be aware of the potential for abuse of
these medications, especially when consumed in large quantities, which
should signal concern and the possible need for intervention.

Commonly Abused Prescription Medications
Although many prescription medications can be abused, the following three
classes are most commonly abused:

Opioids-usually prescribed to treat pain.

CNS depressants-used to treat anxiety and sleep disorders.

Stimulants-prescribed to treat ADHD and narcolepsy.

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snip

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Title Postmarketing surveillance of prescription drugs.
Publisher DIANE Publishing
ISBN 1428924256, 9781428924253

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Title The guide to off-label prescription drugs: new uses for FDA-approved
prescription drugs
Authors Kevin Loughlin, Joyce Generali
Editors Kevin Loughlin, Joyce Generali
Edition illustrated
Publisher Simon and Schuster, 2006
ISBN 0743286677, 9780743286671
Length 1179 pages

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Title Safety and efficacy of non-prescription (OTC) analgesics and NSAIDs:
proceedings of the International Conference held at the South San
Francisco Conference Center, San Francisco, CA, USA on Monday 17th March
1997
Authors K. D. Rainsford, Michael C Powanda
Editors K. D. Rainsford, Michael C Powanda
Edition illustrated
Publisher Springer, 1997
ISBN 0792387376, 9780792387374
Length 150 pages

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Title Prescription Drugs: Alternative Uses, Alternative Cures: Over 1,500
New Uses for FDA-Approved Drugs
Authors Kevin Loughlin, Joyce Generali
Editors Kevin Loughlin, Joyce Generali
Publisher Simon and Schuster, 2007
ISBN 0743286715, 9780743286718
Length 1712 pages

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Title Worst pills, best pills: a consumer's guide to avoiding drug-induced
death or illness
Author Sidney M. Wolfe
Edition revised
Publisher Simon and Schuster, 2005
ISBN 0743492560, 9780743492560
Length 960 pages

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Title Drug Therapy in Nursing
M - Medicine Series
Authors Diane S. Aschenbrenner, Samantha J. Venable
Edition 3, illustrated, revised
Publisher Lippincott Williams & Wilkins, 2008
ISBN 0781765870, 9780781765879
Length 1344 pages

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Title Textbook of pharmacoepidemiology
Author Stephen E. Kimmel
Editors Brian L. Strom, Stephen E. Kimmel
Edition illustrated, abridged
Publisher John Wiley and Sons, 2006
ISBN 0470029250, 9780470029251
Length 498 pages

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Title Melmon and Morrelli's clinical pharmacology: basic principles in
therapeutics
Authors Kenneth L. Melmon, S. George Carruthers
Editors Kenneth L. Melmon, S. George Carruthers, Howard F. Morrelli
Edition 4, illustrated
Publisher McGraw-Hill Professional, 2000
ISBN 0071054065, 9780071054065
Length 1433 pages

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Title Our Daily Meds: How the Pharmaceutical Companies Transformed
Themselves Into Slick Marketing Machines and Hooked the Nation on
Prescription Drugs
Author Melody Petersen
Edition illustrated
Publisher Macmillan, 2009
ISBN 0312428251, 9780312428259
Length 448 pages

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Title Prescription Drugs 2007
The Johns Hopkins White Papers
Author Brent G. Petty
Publisher Johns Hopkins Health, 2007
ISBN 1933087528, 9781933087528
Length 49 pages

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Title Dietary supplements review of healthrelated call records for users
of Metabolife 356 : report to the Chairman, Subcommittee on Wellness and
Human Rights, Committee on Government Reform, House of Representatives.
Author United States, General Accounting Office
Publisher DIANE Publishing
ISBN 1428939768, 9781428939769

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Title ADA Quick Guide to Drug-Supplement Interactions
Author Alan P. Agins, PhD
Publisher American Dietetic Association
ISBN 0880914483, 9780880914482

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Title Drug injury: liability, analysis, and prevention
Authors James O'Donnell (Pharm. D.), Gopi Doctor Ahuja
Edition 2, illustrated
Publisher Lawyers & Judges Publishing Company, 2005
ISBN 0913875279, 9780913875278
Length 894 pages

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Title Drug injury: liability, analysis, and prevention
Authors James O'Donnell (Pharm. D.), Gopi Doctor Ahuja
Edition 2, illustrated
Publisher Lawyers & Judges Publishing Company, 2005
ISBN 0913875279, 9780913875278
Length 894 pages

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Title The essential guide to herbal safety
Authors Simon Mills, Kerry Bone
Edition revised
Publisher Elsevier Health Sciences, 2005
ISBN 0443071713, 9780443071713
Length 684 pages

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Title Pharmacovigilance from A to Z: adverse drug event surveillance
Authors Barton L. Cobert, Pierre Biron
Edition 3, illustrated
Publisher Wiley-Blackwell, 2001
ISBN 0632045868, 9780632045860
Length 235 pages

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Title Prescription Drug Abuse
What's the deal?
Author Karla Fitzhugh
Edition illustrated
Publisher Heinemann-Raintree Library, 2005
ISBN 1403470243, 9781403470249
Length 56 pages

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Title The Risks of Prescription Drugs
The Columbia University Press and Social Science Research Council Series
on the Privatization of Risk
A Columbia / SSRC Book (Privatization of Risk) Series
Columbia/SSRC Books on the Privatization of Risk
Columbia/SSRC book
Author Don Light
Editor Don Light
Publisher Columbia University Press, 2009
ISBN 0231146930, 9780231146937
Length 167 pages

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Title Prescription Alternatives:Hundreds of Safe, Natural,
Prescription-Free Remedies to Restore and Maintain Your Health, Fourth
Edition
Prescription Alternatives
Authors Earl Mindell, Virginia Hopkins
Edition 4
Publisher McGraw-Hill Professional, 2009
ISBN 0071600310, 9780071600316
Length 448 pages

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Title PDR Pocket Guide to Prescription Drugs, 9th Edition
PDR POCKET GUIDE TO PRESCRIPTION DRUGS
Physicians' Desk Reference Pocket Guide to Prescription Drugs
Author Thompson PDR
Edition 9, revised
Publisher Simon and Schuster, 2009
ISBN 1439143080, 9781439143087
Length 1574 pages

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Title Neurotoxic side effects of prescription drugs
Author John Calvin M. Brust
Edition 2, illustrated
Publisher Butterworth-Heinemann, 1996
Original from the University of Michigan
Digitized Aug 6, 2008
ISBN 075069663X, 9780750696630
Length 435 pages

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Title Powerful medicines:
the benefits, risks, and costs of prescription drugs
Vintage Series
Author Jerry Avorn
Edition revised
Publisher Random House Digital, Inc., 2005
ISBN 1400030781, 9781400030781
Length 480 pages

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Title 1,001 Prescription Drugs:
Side Effects, Dangerous Combinations, and
Natural Healing Alternatives for Seniors
Author FC&A Publishing
Publisher F C & A Pub, 2001
ISBN 1890957437, 9781890957438
Length 387 pages

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Title PDR guide to drug interactions, side effects, indications,
contraindications: keyed to PDR 51 edition, 1997
Author Mukesh Mehta
Edition 51, illustrated
Publisher Medical Economics Data, 1997
ISBN 1563632063, 9781563632068
Length 1608 pages

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Title Prescription for disaster: the hidden dangers in your medicine
cabinet
Author Thomas J. Moore
Edition illustrated
Publisher Simon & Schuster, 1998
Original from the University of California
Digitized Sep 10, 2010
ISBN 0684829983, 9780684829982
Length 271 pages

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Temple Summon Search

http://temple.summon.serialssolutions.com/search?s.cmd=
setHoldingsOnly(false)&s.pn=1&s.q=%22prescription+drugs%22+
and+(%E2%80%9Cadverse+effects%E2%80%9D+OR+%E2%80%9Cside+
reaction%E2%80%9D+OR+%E2%80%9Cadverse+reaction%E2%80%9D+
OR+%E2%80%9Cadverse+event%22+OR+%22side+effects%E2%80%9D)

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A shorter URL for the above link:

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http://tinyurl.com/3tkdzkn

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Including:

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Adverse drug reactions
Author: Alison Innes
Practice Nurse
Vol: 32 Issue: 4 ISSN: 0953-6612 Date: 09/2006 Start Page: 25

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Adverse drug reactions: reducing the burden of treatment
Author: Jordan, S
Nursing standard (Royal College of Nursing (Great Britain) :
1987) Vol: 21 Issue: 34 ISSN: 0029-6570 Date: 05/2007 Start Page: 35

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Joining the DoTS: new approach to classifying adverse drug reactions
Author: Robin E. Ferner and Jeffrey K. Aronson
BMJ: British Medical Journal
Vol: 327 Issue: 7425 Edition: International
edition ISSN: 0959-8146 Date: 11/2003 Pages: 1222 - 1225

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Adverse drug reactions: definitions, diagnosis, and management
Author: Edwards, I R and Aronson, J K
Lancet
Vol: 356 Issue: 9237 ISSN: 0140-6736 Date: 10/2000 Pages: 1255 - 1259

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Adverse drug reactions
Author: Barrie McCombs
Canadian Journal of Rural Medicine
Vol: 11 Issue: 2 ISSN: 1203-7796 Date: 04/2006 Start Page: 131

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Population-based studies of adverse drug effects
Author: Ray, Wayne A
The New England journal of medicine
Vol: 349 Issue: 17 ISSN: 0028-4793
Date: 10/2003 Pages: 1592 - 1594

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WEBBIB1011

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Sincerely,
David Dillard
Temple University
(215) 204 - 4584
jw...@temple.edu
http://daviddillard.businesscard2.com

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