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Encyclopedia > Adverse drug reaction

An adverse drug reaction (abbreviated ADR) or adverse drug event (abbreviated ADE) is an expression that describes the unwanted, negative consequences associated with the use of given medications. An ADR is a particular type of adverse effect. The meaning of this expression differs from the meaning of "side effect", as this last expression Preeya is Gay! also imply that the effects can be beneficial.[1] The study of ADRs is the concern of the field known as pharmacovigilance. This article does not cite any references or sources. ... Adverse effect, in medicine, is an abnormal, harmful, undesired and/or unintended side-effect, although not necessarily unexpected, which is obtained as the result of a therapy or other medical intervention, such as drug/chemotherapy, physical therapy, surgery, medical procedure, use of a medical device, etc. ... Pharmacovigilance the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effect, of medicines (Source: The Importance of Pharmacovigilance, WHO 2002). ...

Contents

Classification

ADRs may be classified by e.g. cause and severity.


Cause

  • Type A: Augmented pharmacologic effects
  • Type B: Bizarre effects (or idiosyncratic)
  • Type C: Chronic effects
  • Type D: Delayed effects
  • Type E: End-of-treatment effects
  • Type F: Failure of therapy

Types A and B were proposed in the 1970s,[2] and the other types were proposed subsequently when the first two proved insufficient to classify ADRs.[3] Idiosyncratic drug reactions, also known as type B reactions, are drug reactions which occur rarely and unpredictably amongst the population. ...


Severity

The American Food and Drug Administration defines severe effects as:[4]: “FDA” redirects here. ...

  • Death
  • Life-Threatening
  • Hospitalization (initial or prolonged)
  • Disability - significant, persistent, or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities or quality of life.
  • Congenital Anomaly
  • - or -
  • Requires Intervention to Prevent Permanent Impairment or Damage

Overall Drug Risk

While no official scale exists yet to communicate overall drug risk, the iGuard Drug Risk Rating System is a five color rating scale similar to the Homeland Security Advisory System[5]: iGuard is the holding company for iGuard. ... HSAS redirects here. ...

  • Red (High Risk)
  • Orange (Elevated Risk)
  • Yellow (Guarded Risk)
  • Blue (General Risk)
  • Green (Low Risk)

Location

Adverse effects may be local, i.e. limited to a certain location, or systemic, where a medication has caused adverse effects throughout the systemic circulation. Systemic circulation is the portion of the cardiovascular system which carries oxygenated blood away from the heart, to the body, and returns deoxygenated blood back to the heart. ...


For instance, some ocular antihypertensives cause systemic effects[6], although they are administered locally as eye drops, since a fraction escapes to the systemic circulation. Eye drops are saline-containing drops used as a vector to administer medication in the eye. ...


Mechanisms

As research better explains the biochemistry of drug use, less ADRs are Type B and more are Type A. Common mechanisms are:

  • Abnormal pharmacokinetics due to
    • genetic factors
    • comorbid disease states
  • Synergistic effects between either
    • a drug and a disease
    • two drugs

Abnormal pharmacokinetics

Comorbid disease states

Various diseases, especially those that cause renal or hepatic insufficiency, may alter drug metabolism. Resources are available that report changes in a drug's metabolism due to disease states.[7] Renal failure or kidney failure is a situation in which the kidneys fail to function adequately. ... Liver failure is the final stage of liver disease. ...


Genetic factors

Abnormal drug metabolism may be due to inherited factors of either Phase I oxidation or Phase II conjugation.[8][9] Pharmacogenomics is the study of the inherited basis for abnormal drug reactions.


Phase I reactions

Inheriting abnormal alleles of cytochrome P450can alter drug metabolism. Tables are available to check for drug interactions due to P450 interactions.[10].[11] An allele (pronounced , ) (from the Greek αλληλος, meaning each other) is one member of a pair or series of different forms of a gene. ... Cytochromes are generally membrane-bound proteins that contain heme groups and carry out electron transport or catalyse reductive/oxidative reactions. ... Cytochrome P450 Oxidase (CYP2E1) Cytochrome P450 oxidase (commonly abbreviated CYP) is a generic term for a large number of related, but distinct, oxidative enzymes (EC 1. ...


Inheriting abnormal butyrylcholinesterase (pseudocholinesterase) may affect metabolism of drugs such as succinylcholine[12] In biochemistry, cholinesterase is an enzyme which catalyzes the hydrolysis of the neurotransmitter acetylcholine into choline and acetic acid, a reaction necessary to allow a cholinergic neuron to return to its resting state after activation. ... In biochemistry, cholinesterase is an enzyme which catalyzes the hydrolysis of the neurotransmitter acetylcholine into choline and acetic acid, a reaction necessary to allow a cholinergic neuron to return to its resting state after activation. ... Suxamethonium chloride (also known as succinylcholine, or scoline) is a white crystalline substance, it is odourless and highly soluble in water. ...


Phase II reactions

Inheriting abnormal N-acetyltransferase which conjugated some drugs to facilitate excretion may affect the metabolism of drugs such as isoniazid, hydralazine, and procainamide.[12][11] Chemical structure of an acetyl group bound to the remainder R of a molecule. ... Isoniazid (also called isonicotinyl hydrazine or isonicotinic acid hydrazide); abbreviated INH or just H. Isoniazid is a first-line antituberculous medication used in the prevention and treatment of tuberculosis. ... Hydralazine hydrochloride (1 -hydrazinophthalazine monohydrochloride; Apresoline®) is a medication used to treat high blood pressure. ... Procainamide (trade name Pronestyl®) is a pharmaceutical antiarrhythmic agent used for the medical treatment of cardiac arrhythmias, classified by the Vaughan Williams classification system as class Ia. ...


Inheriting abnormal thiopurine S-methyltransferase may affect the metabolism of the thiopurine drugs mercaptopurine and azathioprine.[11] Thiopurine methyltransferase, drawn from PDB 2BZG. Thiopurine methyltransferase or thiopurine S-methyltransferase (TPMT) is an enzyme (EC 2. ... Mercaptopurine: chemical structure Mercaptopurine (also called 6-MP or by its brand name Purinethol®) is an immunosuppressive drug used to treat leukemia. ... Azathioprine is a chemotherapy drug, now rarely used for chemotherapy but more for immunosuppression in organ transplantation, autoimmune disease such as rheumatoid arthritis or inflammatory bowel disease such as Crohns disease. ...


Interactions with other drugs

The risk of drug interactions are increased with polypharmacy. A drug interaction is a situation in which a substance affects the activity of a drug, i. ... The term polypharmacy generally refers to the use of multiple-medications by a patient. ...


Protein binding

These interactions are usually transient and mild until a new steady state is achieved.[13][14] These are mainly for drugs without much first-pass liver metabolism. The prinicple plasma proteins for drug binding are:[15]

  1. albumin
  2. α1-acid glycoprotein
  3. lipoproteins

Some drug interactions with warfarin are due to changes in protein binding.[15] Albumin can refer to ovalbumin, the principal protein in egg white albumins, a group of proteins including serum albumin and together constituting roughly 60% of the protein in blood plasma. ... Warfarin (also known under the brand names of Coumadin, Jantoven, Marevan, and Waran) is an anticoagulant medication that is administered orally or, very rarely, by injection. ...


Cytochrome P450

Patients have abnormal metabolism by cytochrome P450 due to either inheriting abnormal alleles or due to drug interactions. Tables are available to check for drug interactions due to P450 interactions.[16]. Cytochromes are generally membrane-bound proteins that contain heme groups and carry out electron transport or catalyse reductive/oxidative reactions. ... Cytochrome P450 Oxidase (CYP2E1) Cytochrome P450 oxidase (commonly abbreviated CYP) is a generic term for a large number of related, but distinct, oxidative enzymes (EC 1. ... An allele (pronounced , ) (from the Greek αλληλος, meaning each other) is one member of a pair or series of different forms of a gene. ...


Synergistic effects

An example of synergism is two drugs that both prolong the QT interval. Schematic representation of normal ECG trace (sinus rhythm), with waves, segments, and intervals labeled. ...


Assessing causality

A simple scale is available at http://annals.org/cgi/content/full/140/10/795.[1]


An ADR should not be labeled as 'certain' unless the ADR abates with a challenge-dechallenge-rechallenge protocol.


A more complicated scale is the Naranjo algorithm.


Monitoring bodies

Many countries have official bodies that monitor drug safety and reactions. On an international level, the WHO runs the Uppsala Monitoring Centre, and the European Union runs the European Medicines Agency (EMEA). In the United States, the Food and Drug Administration (FDA) is responsible for monitoring post-marketing studies. Look up who in Wiktionary, the free dictionary. ... The Uppsala Monitoring Centre (the UMC), located in Uppsala, Sweden, is the field name for the World Health Organization Collaborating Centre for International Drug Monitoring. ... The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. ... “FDA” redirects here. ...


See also

EudraVigilance is the European data processing network and management system for reporting and evaluation of suspected adverse reactions during the development of new drugs and also for following the marketing authorisation of medicinal products in the European Economic Area (EEA). ... A paradoxical reaction is the result of a medical treatment that yields the exact opposite of normally-expected results. ... The term polypharmacy generally refers to the use of multiple-medications by a patient. ... Toxicology (from the Greek words toxicos and logos [1]) is the study of the adverse effects of chemicals on living organisms [2]. It is the study of symptoms, mechanisms, treatments and detection of poisoning, especially the poisoning of people. ... The Medical Letter on Drugs and Therapeutics, commonly referred to simply as The Medical Letter, provides independent, unbiased critical evaluations of new drugs and sometimes older drugs when important new information becomes available. ... The Yellow Card Scheme is a UK initiative run by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM) to gather information on Adverse Drug Reactions (ADRs) to medicines. ...

References

  1. ^ a b Nebeker JR, Barach P, Samore MH (2004). "Clarifying adverse drug events: a clinician's guide to terminology, documentation, and reporting". Ann. Intern. Med. 140 (10): 795-801. PMID 15148066. 
  2. ^ Rawlins MD, Thompson JW. Pathogenesis of adverse drug reactions. In: Davies DM, ed. Textbook of adverse drug reactions. Oxford: Oxford University Press, 1977:10.
  3. ^ Aronson JK. Drug therapy. In: Haslett C, Chilvers ER, Boon NA, Colledge NR, Hunter JAA, eds. Davidson's principles and practice of medicine 19th ed. Edinburgh: Elsevier Science, 2002:147-63. ISBN 0-44307-035-0.
  4. ^ MedWatch - What Is A Serious Adverse Event?. Retrieved on 2007-09-18.
  5. ^ "'Traffic-light' medicine risk website to launch", The Guardian, 2007-10-02. 
  6. ^ Rang, H. P. (2003). Pharmacology. Edinburgh: Churchill Livingstone. ISBN 0-443-07145-4.  Page 146
  7. ^ Clinical Drug Use. Retrieved on 2007-09-18.
  8. ^ Phillips KA, Veenstra DL, Oren E, Lee JK, Sadee W (2001). "Potential role of pharmacogenomics in reducing adverse drug reactions: a systematic review". JAMA 286 (18): 2270–9. PMID 11710893. 
  9. ^ Goldstein DB (2003). "Pharmacogenetics in the laboratory and the clinic". N. Engl. J. Med. 348 (6): 553–6. doi:10.1056/NEJMe020173. PMID 12571264. 
  10. ^ Drug-Interactions.com. Retrieved on 2007-09-18.
  11. ^ a b c Weinshilboum R (2003). "Inheritance and drug response". N. Engl. J. Med. 348 (6): 529–37. doi:10.1056/NEJMra020021. PMID 12571261. 
  12. ^ a b Evans WE, McLeod HL (2003). "Pharmacogenomics--drug disposition, drug targets, and side effects". N. Engl. J. Med. 348 (6): 538–49. doi:10.1056/NEJMra020526. PMID 12571262. 
  13. ^ DeVane CL (2002). "Clinical significance of drug binding, protein binding, and binding displacement drug interactions". Psychopharmacology bulletin. 36 (3): 5–21. PMID 12473961. 
  14. ^ Benet LZ, Hoener BA (2002). "Changes in plasma protein binding have little clinical relevance". Clin. Pharmacol. Ther. 71 (3): 115–21. doi:10.1067/mcp.2002.121829. PMID 11907485. OVID full text summary table at OVID
  15. ^ a b Sands CD, Chan ES, Welty TE (2002). "Revisiting the significance of warfarin protein-binding displacement interactions". The Annals of pharmacotherapy 36 (10): 1642–4. PMID 12369572. 
  16. ^ Drug-Interactions.com. Retrieved on 2007-09-18.

Year 2007 (MMVII) was a common year starting on Monday of the Gregorian calendar in the 21st century. ... is the 261st day of the year (262nd in leap years) in the Gregorian calendar. ... For other uses, see Guardian. ... Year 2007 (MMVII) was a common year starting on Monday of the Gregorian calendar in the 21st century. ... is the 275th day of the year (276th in leap years) in the Gregorian calendar. ... Year 2007 (MMVII) was a common year starting on Monday of the Gregorian calendar in the 21st century. ... is the 261st day of the year (262nd in leap years) in the Gregorian calendar. ... A digital object identifier (or DOI) is a standard for persistently identifying a piece of intellectual property on a digital network and associating it with related data, the metadata, in a structured extensible way. ... Year 2007 (MMVII) was a common year starting on Monday of the Gregorian calendar in the 21st century. ... is the 261st day of the year (262nd in leap years) in the Gregorian calendar. ... A digital object identifier (or DOI) is a standard for persistently identifying a piece of intellectual property on a digital network and associating it with related data, the metadata, in a structured extensible way. ... A digital object identifier (or DOI) is a standard for persistently identifying a piece of intellectual property on a digital network and associating it with related data, the metadata, in a structured extensible way. ... A digital object identifier (or DOI) is a standard for persistently identifying a piece of intellectual property on a digital network and associating it with related data, the metadata, in a structured extensible way. ... Year 2007 (MMVII) was a common year starting on Monday of the Gregorian calendar in the 21st century. ... is the 261st day of the year (262nd in leap years) in the Gregorian calendar. ...

External link

Image File history File links This is a lossless scalable vector image. ...

  Results from FactBites:
 
Adverse drug reaction - Wikipedia, the free encyclopedia (175 words)
An adverse drug reaction (abbreviated ADR) is a term to describe the unwanted, negative consequences sometimes associated with the use of different medications.
The focused study of ADRs is the concern of the field known as pharmacovigilance.
While ADR is probably the most precise term to describe the concept, it is not widely used in the community since it may be perceived as jargon and because of the negative-associations with the term "drug".
AER: Info for Health Profs - Adverse Drug Reactions (516 words)
Drug reaction mechanisms may either be non-specific or specific to the patient.
Drug interactions - where the action of a drug alters the efficacy or toxicity of another drug e.g.
Where there is suspicion of a drug allergy and a need to confirm the diagnosis in the setting of negative skin or in-vitro tests, then controlled challenge with the drug is a useful diagnostic tool.
  More results at FactBites »

 
 

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