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, symptomer og skader foråsaget af pillerne, 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.
Ny rapport på dansk.
Nærværende rapport redegør detaljeret for konsekvenserne af flere års umådeholdende udskrivning af psykofarmaka, som har medført, at 548.302 danskere, heriblandt 25.000 børn, lige nu er på psykofarmaka.
Hvert år dør et ukendt antal mennesker af behandlingen, da alle regler om påpasselighed for det meste tilsidesættes, og der kastes røgslør ud i statistikkerne, så disse er svære at blive kloge på.
Selv om psykofarmaka er forbeholdt mennesker med psykiske problemer, er disse blevet udskrevet til hvem som helst mod hvad som helst under paroler fra Dansk Psykiatrisk Selskab om, at det er ”helt harmløse midler omtrent uden bivirkninger”.
Tryk her for at hente rapporten i PDF.
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.
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
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.
Drik aldrig alkohol når du får lykkepiller - Lykkepiller.info
Advarsler udlandet :
Manglende dokumentation for serotonin teorien.
Serotonin og Depression, En teori : Dec. 2005. A Disconnect between the Advertisements and the Scientific Literature.
Serotoninsyndrom
The Serotonin Syndrome is a potentially lethal condition caused by excessive serotonergic activity. It is a very dangerous and a potentially fatal side effect of the serotonergic enhancing drugs such as SSRI & SSNRI antidepressants and is diagnosed by the presence of at least 3 of 10 symptoms: mental status changes (confusion, hypomania), agitation, myoclonus, hyperreflexia, diaphoresis, shivering, tremor, diarrhea, incoordination, and fever. This "hyperserotonergic" toxic condition requires heightened clinical awareness in order to prevent, recognize, and treat the condition promptly. Promptness is vital because, as we just mentioned, the serotonin syndrome can be fatal and death from this side effect can come very rapidly. The Serotonin syndrome is brought on by excessive levels of serotonin and is difficult to distinguish from the "Neuroleptic Malignant Syndrome" because the symptoms are so similar. The "Neuroleptic Malignant Syndrome" is a serious condition brought on by the use of neuroleptic drugs (anti-psychotics).
Source: Prozac: Panacea or Pandora? by Dr Ann Blake Tracy http://www.outlookcities.com/psych/
Source: Journal of Clinical Psychiatry.
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.
Selective Serotonin/Norepinephrine Reuptake Inhibitors (SNRIs) FDA. - Serotonin syndrome occurs when the body has too much of a chemical found in the nervous system (serotonin). Each of the above medications (triptans, SSRIs, and SNRIs), cause an increase in serotonin levels. Symptoms of serotonin syndrome may include restlessness, hallucinations, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhea.
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.
Parkinsonisme
Must We Now Consider SRIs Neuroleptics? The bad news is, the SRIs are clearly capable of causing parkinsonian side effects, akathisia, and-perhaps most worrisome-dyskinetic movements that may resemble tardive dyskinesia. I suspect that very few clinicians prescribing SRIs routinely inform their patients of possible EPS, although I have not seen data on this issue. Although we may be encouraged by the low numbers of spontaneous reports of SRI-related EPS-relative to the population at risk-we simply do not know how many cases are being overlooked. Neither do we know how many cases will develop in patients taking these agents for 5, 10, 15, or more years.
Træthedssyndrom
SSRI- Præparater og kronisk træthedssyndrom
The adverse effect most frequently reported as the reason for early discontinuation or switching was drowsiness/fatigue (10.2%), followed by anxiety, headache, and nausea - all at just over 5%.
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.
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".
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.
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.
Aggression, selvskade, selvmord, selvmordstanker og adfærd.
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.
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.
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.
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
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.
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.
Manglende effekt af ssri
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."
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.
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".
Hjerneatrofi
Vigtigt at granske alarmerende fund om neuroleptika og hjernetrofi. Uppgifter om alarmerande biverkningar bör leda till att en producentobunden panel omgående granskar eventuella risker vid neuroleptikabehandling.
Neurologiske skader
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.
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.
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".
Tardive Dyskinesia/Dystonia, Parkinsonism & Akathisia
SSRI & SSNRI antidepressants induced side-effects (Iatrogenic Extrapyramidal Symptoms) are
recognized to be similar to Neuroleptic (anti-psychotic) induced side-effects. These side-effects are known as Tardive Dyskinesia/Dystonia (severe body movement disorder, mostly permanent), Parkinsonism (a sign of future Parkinson's disease) and Akathisia (a Neurological driven severe mania/agitation that can lead to suicidality, suicide attempts, self-harm & suicide). It is well documented in the medical literature that these neuroleptic induced side-effects refer to damage at dopaminergic neurons in the "motor system" of the
"Basal Ganglia", a structure deep in the "Limbic System" of the brain. 1, 2, 3, 4, http://www.emedicine.com/EMERG/topic338.htm (scroll down).
Sexual dysfunktion
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.
Krav om advarseler - "black box warnings"
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).
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.
Knogleskørhed
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.
Antidepressiver til børn
Analyse af antidepressiver til børn og unge - European medicines agency 25 April 2005.
Forgiftninger og Hjerneskader :
SSRI/SSNRI-induced Toxicity & Brain Damage by disrupting the balance of Body & Brain Metabolism
SSRI's are "Selective Serotonin Re-Uptake Inhibitors." In contrast to the deceiving claim of the pharmaceutical companies that SSRI's or SSNRI's may correct some sort of "biochemical imbalance" of serotonin in the brain, all of these serotonergic agents actually cause major and dangerous imbalances in the brain and the body, evidenced by the many medical reports (below) of severe toxic neurological and physical side-effects. Neuronal re-uptake of neurotransmitters is metabolism. What serotonin re-uptake inhibitor actually means is that the SSRI-antidepressant interferes with ones ability to metabolise serotonin, so that can and will build up to toxic amounts after prolonged use. In other words, an SSRI-antidepressant impairs the ability of cells to metabolise serotonin, not only in the brain, but -since serotonin is widely distributed throughout the body- in the body as well! The greatest concentration of serotonin, around 90%, is not found in the brain, but is found in the gastrointestinal or digestive tract (human gut, intestines, bowels).
Originally, the neurotransmitter serotonin -thought to be secreted by the Pineal Gland- is called a neurohormone, because of it's specific regulatory effect on the activity of the Endocrine Glands in the human body. (1),(2) Affecting serotonin thus means also affecting the Glandular Endocrine System. Next to it, serotonin affects the Cardiovascular System and the Respiratory System, under which, the lungs. Serotonin is also found in blood platelets and stimulates platelet aggregation (blood clotting). Furthermore, serotonin is known to affect contraction of smooth muscles (such as those of the gut) and blood vessel elasticity (vasoconstriction and expansion). More information: Serotonin & the Pineal Gland
A recent study (25 sept, 2004) shows us clearly that serotonin toxicity can even appear rapidly in a few hours after taking a single therapeutic dose of SSRI medication. In Bio-Psychiatry it is a common thought that SSRI's are believed to have their effect by inhibiting the re-uptake of serotonin (downregulation of transporters) and thereby gradually increasing serotonin outside the tissue cell wall (extracellular) in the synaptic gap between brain cells (neurons) in the brain. In this important study, Zoloft (Lustral, sertraline) was given to monkeys for 4 weeks to establish how long it would take before Zoloft would have it's effect on serotonergic neurons and thus elevation of serotonin. In contrast with the commonly accepted SSRI theory, it was observed that serotonin levels raised NOT gradually, but rapidly and dramatically and kept on raising during these 4 weeks, an effect that can NOT be ascribed solely to a "re-uptake inhibition" of serotonin!
Antidepressant induced neurological and/or physical toxicity (body and/or brain damage) either as a result of prolonged inhibition of P450-2D6 liver-enzymes, or as a result of impairing serotonin metabolism, can take on many forms as described below. A few examples are: Hyperserotonemia, such as the lifethreatening condition the Serotonin Syndrome, Epileptiform Discharges, Epileptic Seizures and/or Epilepsy, Hypoglycaemia/Hyperglycemia (Low/Elevated Blood Sugar Imbalance), Stroke/Hemorrhagic Syndromes, Frontal Lobe Syndrome, Tardive Dyskinesia/Dystonia, Parkinsonism, Akathisia, Mania, etc...
DEPARTMENT OF HEALTH AND HUMAN SERVICES - PSYCHOPHARMACOLOGIC DRUGS ADVISORY COMMITTEE
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