Side effect
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Inmedicine,aside effectis an effect of the use of a medicinaldrugor other treatment, usuallyadversebut sometimes beneficial, that is unintended. Herbal andtraditional medicinesalso have side effects.
A drug or procedure usually used for a specific effect may be used specifically because of a beneficial side-effect; this is termed "off-label use"until such use is approved.[1]For instance,X-rayshave long been used asan imaging technique;the discovery of their oncolytic capability led to their use inradiotherapyfor ablation ofmalignanttumours.
Frequency of side effects
[edit]
TheWorld Health Organizationand other health organisations characterise the probability of experiencing side effects as:[4][5]
- Very common, ≥1⁄10
- Common (frequent),1⁄10to1⁄100
- Uncommon (infrequent),1⁄100to1⁄1000
- Rare,1⁄1000to1⁄10000
- Very rare, <1⁄10000
TheEuropean Commissionrecommends that the list should contain only effects where there is "at least a reasonable possibility" that they are caused by the drug and the frequency "should represent crude incidence rates (and not differences or relative risks calculated against placebo or other comparator)".[6]The frequency describes how often symptoms appearaftertaking the drug, without assuming that they were necessarilycaused bythe drug. Both healthcare providers[7]and lay people[8]misinterpret the frequency of side effects as describing the increase in frequency caused by the drug.
Examples of therapeutic side effects
[edit]Most drugs and procedures have a multitude of reported adverse side effects; the information leaflets provided with virtually all drugs list possible side effects. Beneficial side effects are less common; some examples, in many cases of side-effects that ultimately gained regulatory approval as intended effects, are:
- Bevacizumab(Avastin), used to slow the growth of blood vessels, has been used against dry age-relatedmacular degeneration,as well asmacular edemafrom diseases such asdiabetic retinopathyandcentral retinal vein occlusion.[9]
- Buprenorphinehas been shown experimentally (1982–1995) to be effective against severe, refractory depression.[10][11]
- Bupropion(Wellbutrin), ananti-depressant,also helps smoking cessation; this indication was later approved, and the name of the drug as sold for smoking cessation is Zyban. Bupropion branded as Zyban may be sold at a higher price than as Wellbutrin, so some physicians prescribe Wellbutrin for smoking cessation.[citation needed]
- Carbamazepineis an approved treatment forbipolar disorderandepileptic seizures,but it has side effects useful in treatingattention-deficit hyperactivity disorder(ADHD),schizophrenia,phantom limbsyndrome,paroxysmal extreme pain disorder,neuromyotonia,andpost-traumatic stress disorder.[12]
- Dexamethasoneandbetamethasoneinpremature labor,to enhance pulmonary maturation of the fetus.[13]
- Doxepinhas been used to treatangioedemaand severe allergic reactions due to its strongantihistamineproperties.[14]
- Gabapentin,approved for treatment ofseizuresandpostherpetic neuralgiain adults, has side effects which are useful in treating bipolar disorder,essential tremor,hot flashes,migraineprophylaxis,neuropathic painsyndromes, phantom limb syndrome, andrestless leg syndrome.[15]
- Hydroxyzine,an antihistamine, is also used as ananxiolytic.[citation needed]
- Magnesium sulfatein obstetrics forpremature laborandpreeclampsia.[13]
- Methotrexate(MTX), approved for the treatment ofchoriocarcinoma,is frequently used for the medical treatment of an unrupturedectopic pregnancy.[16]
- TheSSRImedicationsertralineis approved as an antidepressant but delayssexual climaxin men, and can be used to treatpremature ejaculation.[17]
- Sildenafilwas originally intended forpulmonary hypertension;subsequently, it was discovered that it also produceserections,for which it was later approved.[citation needed]
- Terazosin,anα1-adrenergic antagonistapproved to treat benign prostatic hyperplasia (enlarged prostate) and hypertension, is (one of several drugs) used off-label to treat drug induceddiaphoresisandhyperhidrosis(excessive sweating).[18][19]
- Thalidomide,a drug soldover the counterfrom 1957 to 1961 as atranquiliserand treatment formorning sicknessof pregnancy, became notorious for causing tens of thousands of babies to beborn without limbsand with other conditions, orstillborn.The drug, though stillsubject to other adverse side-effects,is now used to treatcancersandskin disorders,and is on theWorld Health Organization's List of Essential Medicines.[20]
See also
[edit]- Adverse drug reaction(ADR), a harmful unintended result caused by taking medication
- Combined drug intoxication
- Conservative management
- Drug-drug interaction(DDI), an alteration of the action of a drug caused by the administration of other drugs
- Paradoxical reaction,an effect of a substance opposite to what would usually be expected
- Pharmacogenetics,the use of genetic information to determine which type of drugs will work best for a patient
- Unintended consequences
References
[edit]- ^Due A (2023)."What are side effects?".European Journal for Philosophy of Science.13(1): 16.doi:10.1007/s13194-023-00519-8.PMC10006551.PMID36936702.
- ^"Nicotine Side Effects".Drugs.com.
- ^Schraufnagel DE, Blasi F, Drummond MB, Lam DC, Latif E, Rosen MJ, et al. (September 2014)."Electronic cigarettes. A position statement of the forum of international respiratory societies".American Journal of Respiratory and Critical Care Medicine.190(6): 611–8.doi:10.1164/rccm.201407-1198PP.PMID25006874.S2CID43763340.
- ^"Common and Rare Side Effects for misoprostol oral".
- ^"Definitions"(PDF).8 May 2007. Archived fromthe original(PDF)on 4 March 2016.
- ^"A Guideline on Summary of Product Characteristics"(PDF).European commission.1 September 2009.
- ^Mühlbauer V, Mühlhauser I (November 2015)."Understanding adverse drug reactions in package leaflets - an exploratory survey among health care professionals".BMC Health Services Research.15(1): 505.doi:10.1186/s12913-015-1160-1.PMC4641349.PMID26554666.
- ^Mühlbauer V, Prinz R, Mühlhauser I, Wegwarth O (13 September 2018)."Alternative package leaflets improve people's understanding of drug side effects-A randomized controlled exploratory survey".PLOS ONE.13(9): e0203800.Bibcode:2018PLoSO..1303800M.doi:10.1371/journal.pone.0203800.PMC6136776.PMID30212555.
- ^Boseley S (17 June 2006)."Drugs firm blocks cheap blindness cure".The Guardian.London.Retrieved20 May2010.
- ^Gracer R (February 2007)."The Buprenorphine Effect on Depression"(PDF).naabt.org.National Alliance of Advocates for Buprenorphine Treatment.Retrieved19 September2015.
- ^Bodkin JA, Zornberg GL, Lukas SE, Cole JO (February 1995). "Buprenorphine treatment of refractory depression".Journal of Clinical Psychopharmacology.15(1): 49–57.doi:10.1097/00004714-199502000-00008.PMID7714228.
- ^Leehey K (1 August 2003)."Mood Stabilizers for Bipolar Disorder (Manic Depressive)".Leeheymd.com.Archived fromthe originalon 13 November 2011.Retrieved17 August2011.
- ^abWing DA, Powers B, Hickok D (April 2010). "U.S. Food and Drug Administration drug approval: slow advances in obstetric care in the United States".Obstetrics and Gynecology.115(4): 825–833.doi:10.1097/AOG.0b013e3181d53843.PMID20308845.
- ^Shen WW, Mahadevan J, Hofstatter L, Sata LS (July 1983)."Doxepin as a potent H2 and H2 antihistamine for epigastric distress".The American Journal of Psychiatry.140(7): 957–8.doi:10.1176/ajp.140.7.957.PMID6859336.Archivedfrom the original on 4 September 2011.
- ^"Off-label Use of Gabapentin"(PDF).Idaho Drug Utilization Review, educational leaflet.2004. Archived fromthe original(PDF)on 9 August 2007.
- ^"Pregnancy".drugs.nmihi.com.(New Medical Information and Health Information). Archived fromthe originalon 11 October 2008.
- ^Deem SG."Premature Ejaculation".Emedicine.com.Archivedfrom the original on 1 December 2008.Retrieved17 August2011.
- ^Gelenberg AJ, Freeman MP, Markowitz JC, et al. (2010)."Practice guideline for the treatment of patients with major depressive disorder"(PDF).Am J Psychiatry.167(Suppl 10): 9–118.
- ^Cheshire WP, Fealey RD (2008). "Drug-induced hyperhidrosis and hypohidrosis: incidence, prevention and management".Drug Safety.31(2): 109–26.doi:10.2165/00002018-200831020-00002.PMID18217788.S2CID23041000.
- ^World Health Organization model list of essential medicines: 22nd list.Geneva:World Health Organization.2021.hdl:10665/345533.WHO/MHP/HPS/EML/2021.02.
External links
[edit]- "MedEffect Canada".Health Canada.13 July 2011.
- "Definitions"(PDF).World Health Organization.
