Videnskabelige artikler & advarsler om bivirkninger ved lykkepiller
En ny undersøgelse fra USA viser at lykkepillers virkning overvurderes fordi man kun publicere de positive sider af medicinen, flere forskere mener efterhånden at medicinen er virkningsløs, men bivirkninger er der mange af. Her er samlet forskellige videnskabelige rapporter om bivirkningerne samt advarsler fra lægemiddelstyrelsen. Der foreligger langt mere dokumentation i udlandet derfor er mange af disse links på engelsk.
Citat Dr. David Healy
"Knowing the full picture could mean the difference between life and death", Dr. David Healy said. If we are informed what the risks are, then we don't say, 'it couldn't be the drug,' and increase the dose, which is just the wrong thing to do," he said
Danmark :
Negative resultater bliver ikke publiceret- IRF 22/2-08. Nyt amerikansk studie viser, at den videnskabelige litteratur om moderne antidepressiva er misvisende pga. selektiv publicering af positive fund, så lægemidlernes effekt overvurderes.
Almindelige lægemidler giver selvsmordtanker - FDA 31/1-08. Et nyt studie viser at elleve almindelige mediciner mod epilepsi og bipolare lidelser kan øge risikoen for selvmord og selvmordstanker. De amerikanske (FDA) går frem og advare i mod medikamentene.
Genetiske variationers betydning for effekten af selektive serotoningenoptagelseshæmmere - Ugeskrift for læger 16/4-07 Der er udbredt praksis og god evidens for medicinsk behandling af depressiv sindslidelse. 30-40% af patienterne har dog ikke tilfredsstillende terapeutisk udbytte af en given behandling, og hverken demografiske, kliniske eller biologiske parametre er tilstrækkelige til at forudsige det individuelle behandlingsrespons.
Er brug af selektive serotoningenoptagelseshæmmere associeret med en øget risiko for blødning? - Ugeskrift for læger 25/9-05. I nyere studier er der blevet rejst mistanke om en øget risiko for blødning ved indtagelse af selektive serotoningenoptagelseshæmmer (SSRI)-præparater. I denne oversigtsartikel gennemgås de foreliggende epidemiologiske arbejder. Ved brug af SSRI er der fundet en overhyppighed af flere forskellige klinisk betydende blødningsmanifestationer. I to studier er der fundet en multiplikativ interaktion ved kombineret brug af nonsteroide antiinflammatoriske stoffer (NSAID) og SSRI-præparater. Der er også i Danmark et stort forbrug af denne gruppe antidepressiva. Vi mener, at man bør undgå at ordinere SSRI til personer, der har en høj risiko for at få blødningskomplikationer.
GlaxoSmithkline - GSK egne analyser om selvsmordfare pdf. 2006
Den danske lægemiddelstyrelse - Antidepressiv og risiko for misdannelser - 6/9-05
Alle antidepressiver er farlige - Ekstrabladet d. 24/8 2005. Det kan være direkte livsfarligt at spise lykkepiller! lægemiddelstyrelsen advare.
Den danske lægemiddelstyrelse - Risiko for selvmordstanker og selvmordsadfærd samt risikoen for fjendtlig adfærd såsom udtalt vrede og aggressivitet - 25/4-05
Psykofarmakologi i et genomisk perspektiv - Ugeskrift for læger 21/1-05 Behandlingssvigt eller forekomst af bivirkninger udgør væsentlige problemer ved behandling af psykiatriske sygdomsforløb og påvirker såvel komplians som patientens somatiske helbredssituation.
For meget serotonin og for lidt serotonin - Psykiatri information, oktober 1997, overlæge, dr. Med. Jes Gerlach
Drik aldrig alkohol når du får lykkepiller - Lykkepiller.info
Advarsler udlandet :
Initial severity and Antidepressant Benefits: Ameta-Analysis af data submitted to the FDA. 26/02-08 Plos Medicine - The conclusion: "compared with placebo, the new-generation antidepressants do not produce clinically significant improvements in depression in patients who initially have moderate or even very severe depression."
Journal of Medicin 17/1-2008. - Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy - Background Evidence-based medicine is valuable to the extent that the evidence base is complete and unbiased. Selective publication of clinical trials — and the outcomes within those trials — can lead to unrealistic estimates of drug effectiveness and alter the apparent risk–benefit ratio. Methods We obtained reviews from the Food and Drug Administration (FDA) for studies of 12 antidepressant agents involving 12,564 patients. We conducted a systematic literature search to identify matching publications. For trials that were reported in the literature, we compared the published outcomes with the FDA outcomes. We also compared the effect size derived from the published reports with the effect size derived from the entire FDA data set.
Almindelige lægemidler giver selvsmordtanker - FDA 31/1-08. Et nyt studie viser at elleve almindelige mediciner mod epilepsi og bipolare lidelser kan øge risikoen for selvmord og selvmordstanker. De amerikanske (FDA) går frem og advare i mod medikamentene.
Adverse Drug Reactions Monitoring Center - The aim of this study was to investigate the pattern of adverse reactions reported on SSRIs in Sweden and assess possible risk factors associated with the occurrence of adverse reactions to these agents. METHODS: A survey was made of 1202 reports describing 1861 adverse reactions to SSRIs submitted to the Swedish Adverse Drug Reactions Advisory Committee. RESULTS: The most often reported adverse reactions were neurological symptoms (22.4%), psychiatric symptoms (19.5%) and gastrointestinal symptoms (18.0%); however, dermatological symptoms (11.4%) and general symptoms (9.8%) were also frequent.
Health Canada - Health Canada is advising Canadians that Selective Serotonin Re-uptake Inhibitors (SSRIs) and other newer anti-depressants, now carry stronger warnings. These new warnings indicate that patients of all ages taking these drugs may experience behavioural and/or emotional changes that may put them at increased risk of self-harm or harm to others.
Post SSRI Sexual Dysfunction (PSSD)- is an iatrogenic type of sexual dysfunction caused directly by the previous use of selective serotonin reuptake inhibitor (SSRI) antidepressants. While apparently uncommon, it can last for months, years, or sometimes indefinitely after the discontinuation of SSRIs. It may represent a specific subtype of SSRI discontinuation syndrome.
Antidepressant Use in Children, Adolescents, and Adults - The U.S. Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months).
FDA Information for Healthcare Professionals - 04-24-2007. The FDA recommends that patients treated concomitantly with a triptan and an SSRI/SNRI be informed of the possibility of serotonin syndrome.
David Healy, Andrew Herxheimer, David B. Menkes - 12/9-06 Forbindelsen mellem behandling med antidepressiver og aggression og vold, som her refereres, kræver flere lægelige undersøgelser, mere tilgængelig epidemiologisk materiale, og god lægelig beskrivelse af uønskede følger af behandlingen. Retssystemet må sandsynligvis instille sig på fortsat at blive mødt med sager om vold i tilknytning til brugen af psykotropisk medicin, og det kan tilfalde domstolene at kræve adgang til materiale, som i øjeblikket ikke er tilgængeligt. Det er et internationalt problem, og det kræver en international respons.
Suicide & Death Can Lurk In Each SSRI Pill
For decades research has shown that impairing serotonin metabolism will produce migraines, hot flashes, pains around the heart, difficulty breathing, a worsening of bronchial complaints, tension and anxiety which appear from out of nowhere, depression, suicide - especially very violent suicide, hostility, violent crime, arson, substance abuse, psychosis, mania, organic brain disease, autism, anorexia, reckless driving, Alzheimer's, impulsive behavior with no concern for punishment, and argumentative behavior.
More than 85% of doctors "unaware of SEROTONIN SYNDROME" which can lead to death - Ms. Zion, who went to the hospital with a fever of 103.5, had been taking a prescribed antidepressant, phenelzine (Nardil). The combination of phenelzine and the narcotic painkiller meperidine (Demerol) given to her at the hospital could raise the level of circulating serotonin to dangerous levels. When she became agitated, a symptom of serotonin toxicity, and tried to pull out her intravenous tubes, she was restrained, and the resulting muscular tension is believed to have sent her fever soaring to lethal heights.
An immense number of patients get worse from new antidepressant drugs, says Vice President of The Swedish Psychiatric Association - 16/11-06 Speaking on antidepressants the Vice President of The Swedish Psychiatric Association, Dr. Christina Spjut, said Sunday that "an immense number of persons get worse from this". She said that many persons take these drugs for years "where the antidepressant drugs make them continue to be depressed".
Serotonin og Depression, En teori : Dec. 2005. A Disconnect between the Advertisements and the Scientific Literature.
Ssri øger risikoen for knogleskørhed - 28/11-05. 400 000 nordmænd bruger i dag de såkalte lykkepiller. Pillene kan give varige skader som knogleskørhed.
Osteoporotic fractures - Med page today - Commonly used antidepressants may increase the risk of osteoporotic fractures among patients 50 and older, researchers here found.
Antidepressant Use in Children, Adolescents, and Adults - 12/7-05. Food and Drug Administration (FDA) asks manufacturers of all antidepressant drugs to include in their labeling a boxed warning and expanded warning statements that alert health care providers to an increased risk of suicidality (suicidal thinking and behavior) in children and adolescents being treated with these agents, and additional information about the results of pediatric studies.
Selvmordtanker, aggression og voldelig adfærd - FDA June 30, 2005. Several recent scientific publications suggest the possibility of an increased risk for suicidal behavior in adults who are being treated with antidepressant medications.
Analyse af antidepressiver til børn og unge - European medicines agency 25 April 2005.
Selvskade ved Zoloft - Health Canada May 26, 2004. Stronger WARNING for SSRIs and other newer antidepressants regarding the potential for behavioural and emotional changes, including risk of self- harm
Risiko for misdannelser, fosterskader - FDA (GLS) 5/10-05
Symptomer hos voksne bliver værre med antidepressiver - FDA 1/7-05. Several recent scientific publications suggest the possibility of an increased risk for suicidal behavior in adults who are being treated with antidepressant medications.
Expert Calls for Drug Companies to Publish Safety and Efficacy Data - Dr. Breggin
Frigivet hemmeligholdelse om selvmordsrisiko - Dr. Breggin´s Rapport
Review af voldelig adfærd forårsaget af SSRI - Dr. Breggin
Lykkepiller kan skabe selvsmordtanker i voksne - Guardian England August 22, 2005. Commonly used modern antidepressants can cause adults as well as children to attempt suicide, a new study says.
Suicide attempts in clinical trials with paroxetine randomised against placebo - BMC Medicin. August 2005. Suicidality in Children and Adolescents Being
Treated With Antidepressant Medications - October 15, 2004. Today the Food and Drug Administration (FDA) directed manufacturers of all antidepressant drugs to revise the labeling for their products to include a boxed warning and expanded warning statements that alert health care providers to an increased risk of suicidality (suicidal thinking and behavior) in children and adolescents being treated with these agents, and to include additional information about the results of pediatric studies.
DEPARTMENT OF HEALTH AND HUMAN SERVICES - PSYCHOPHARMACOLOGIC DRUGS ADVISORY COMMITTEE
Zoloft produktresumé :
På det amerikanske produktresumé for Zoloft er der konstateret aggressivitet FØR markedsføringen, altså i forsøg.
På side 32-33 defineres 'infrequent adverse effects' som bivirkninger, der forekommer hos mellem 1/100 og 1/1000 patienter. Under Psychiatric Disorders, side 34, nævnes blandt andet aggressive reaktioner, klassificeret som 'infrequent'. I Danmark klassificeres aggressivitet som 'sjælden', defineret som mellem 1/1000 og 1/10.000 patienter. I USA bliver der altså angivet en 10 gange så hyppig forekomst af aggression som i Danmark!!! Eller, sagt på en anden måde, i Danmark nedtones risikoen meget kraftigt i forhold til i USA. - se side 32-33
Efexor´s produktresumé :
Sidste år blev "Homicidal ideation" er listet som (Rare - sjældent), på Efexor´s produktresume altså Wyeth´s egen Web side.
Se at "SUICIDAL IDEATION" er listet som "Infrequent" som er hyppigere end sjældent.- se side 38
Produktresumeer Danmark :
Her er link til Lægemiddelstyrelsen
Her kan man søge oplysninger omkring den medicin, man får ordineret. Nederst er eksempler på de forskellige produktresumeer for antidepressiver i SSRI gruppen. Du kan selv finde din medicin og finde resumeet ved at trykke på linket øverst:
Akarin, filmovertrukne tabletter 10 mg, 20 mg, 30 mg og 40 mg.doc
Cipralex (Abacus), filmovertrukne tabletter 10 mg, 15 mg og 20 mg.doc
Cipramil, filmovertrukne tabletter 10 mg, 20 mg, 30 mg, 40 mg.doc
Efexor Depot, hårde depotkapsler 75 mg og 150 mg.doc
Fevarin, filmovertrukne tabletter 50 mg og 100 mg.doc
Fontex, opløselige tabletter 20 mg.doc
Seroxat, filmovertrukne tabletter 20 mg og 30 mg.doc
Sertralin Nycomed, filmovertrukne tabletter 50 mg og 100 mg.doc
Zoloft, filmovertrukne tabletter 25 mg, 50 mg og 100 mg.doc