SEROXAT AND OTHER SSRIs

News and Views on the SSRI Group of Drugs

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Posts Tagged ‘SSRIs’

2011 SSRI Related Deaths

Posted by shutah on February 20, 2011

It’s Sunday, 20 February 2011

51 days into the year

43 incidents listed already

 

SSRI Related Deaths 2011

 

Does anyone care?

HOW LONG MUST THIS LIST GET BEFORE GOVERNMENTS AND PHARMACEUTICAL COMPANIES ACKNOWLEDGE THE GLOBAL PROBLEMS SURROUNDING SSRIs?

IT’S NOT ABOUT MONEY, STOCKS, SHARES!

IT’S ABOUT HUMAN LIFE

STOP * LOOK * LISTEN

DO SOMETHING!

 

 


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Posted in GlaxoSmithKline, GSK, MHRA, SSRIs | Tagged: , , , , , , , , , , , , | Leave a Comment »

Crusader’s highly deserved recognition

Posted by shutah on February 19, 2011

Surely, one of the proudest moment’s in Bob Fiddaman’s quest for justice in the eternal fight against SSRI’s .

As Bob writes in his blog “What could piss off GlaxoSmithKline more than Bob Fiddaman getting an award for basically highlighting their dark history?”

Way to go Fiddy!!!!!!

[Click the pic to read the full story]

Posted in Blogroll, Depression, GlaxoSmithKline, GSK, Health, Paroxetine, Paxil, Seroxat, SSRIs | Tagged: , , , , , , | 1 Comment »

SSRI Comparison Facts

Posted by shutah on February 14, 2011

Comparison of Selective Serotonin Reuptake Inhibitors (SSRIs)

Efficacy and effectiveness

Clinical trials comparing one SSRI with another indicate that drugs in this class are equally efficacious. Each antidepressant produces approximately a 60% overall response rate (ie, at least a 50% reduction in symptoms as a result of treatment). However, some differences in the SSRIs efficacy exist.

Escitalopram may be superior in efficacy compared with other SSRIs in the treatment of major depressive disorder2. Also escitalopram has better efficacy in the treatment of severe depression than citalopram4.  A major consideration with escitalopram is that it is not yet available in lower-cost generic form. The drug is still under patent. In 2006 Forest Laboratories was granted an 828 day (2 years and 3 months) extension on its patent for escitalopram31. This pushed the patent expiry from December 7, 2009 to March 14, 2012.

Paroxetine, fluoxetine, and sertraline are similar in effectiveness for major depression and depression with high levels of anxiety3,5.

Paroxetine is the only SSRI indicated for all five anxiety disorders in addition to major depressive disorder.

Fluoxetine has a slower onset of antidepressants effect than other SSRIs4. Also, fluoxetine appears to be somewhat less effective, than other drugs in this class24,25.

Sertraline may have a slightly higher rate of response than fluoxetine and paroxetine26. Sertraline has advantages over paroxetine in the treatment of panic disorder27.

Interesting and important fact is that SSRI antidepressants are not interchangeable. Persons who discontinue one SSRI for lack of tolerability or response can be effectively treated with another19.

Discontinuation symptoms (withdrawal)

SSRIs aren’t considered addictive.  YET !! However, stopping treatment abruptly or missing several doses can cause withdrawal-like symptoms, including nausea, headache, dizziness, lethargy and flu-like symptoms. This is sometimes called discontinuation syndrome.

All antidepressants do not have the same type or severity of withdrawal symptoms. Discontinuation syndrome is more common with the SSRIs with shorter half lives and inactive metabolites, such as paroxetine, sertraline, and fluvoxamine. The incidence of discontinuation syndrome is highest with paroxetine followed by fluvoxamine and sertraline. Citalopram and fluoxetine have a lower occurrence of withdrawal symptoms10.

Abrupt interruption of antidepressant therapy for 5-8 days was associated with the emergence of new somatic and psychological symptoms in patients treated with paroxetine and to a lesser degree sertraline, with few symptoms seen with fluoxetine12.

Pregnancy category

All SSRIs (except paroxetine) are classified as pregnancy Category C, meaning that they may not be safe for use during pregnancy.

Paroxetine (Paxil, Paxil CR) is pregnancy Category D medication. Paroxetine may cause heart defects or serious, life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy.

Pharmacology

Selective serotonin reuptake inhibitors differ in their potency and selectivity in inhibiting serotonin reuptake and there may be important effects on other transporters and receptors, indicating that they are not as selective as their manufacturers suggest. It has been proposed, for example, that fluoxetine’s effects on 5-HT2C receptors may underlie a propensity to cause agitation; paroxetine’s affinity for muscarinic receptors causes its increased tendency to produce discontinuation effects; sertraline’s affinity for the dopamine transporter results in a greater efficacy in severe depression; and sertraline’s and fluvoxamine’s affinity for sigma1 opioid receptors is responsible for their efficacy in psychotic depression (Goodnick & Goldstein, 1998a).

Half-life

The half-life of a drug is the time required to achieve steady-state plasma concentrations (i.e., to metabolize half the dose and lower blood concentrations by 50%). Half-life can be used to estimate how long it will take to clear a drug from the body after treatment is discontinued.

Fluoxetine is unique because of its long half-life and the long half-life of its active metabolite norfluoxetine. Fluoxetine has a half-life of 2-4 days and its active metabolite, norfluoxetine, has a half-life of 4-16 days.

In comparison, citalopram, escitalopram, paroxetine, and sertraline have shorter half-lives in the range of 20-35 hours, and steady-state concentrations (and therapeutic effect) are reached much more rapidly. The long half-life of fluoxetine may blunt the effects of missed doses or treatment discontinuation and makes it easier to discontinue than any of the other SSRIs. On the other hand, fluoxetine requires a much longer washout period than the other SSRIs (several weeks), particularly when switching to monoamine oxidase inhibitors (MAOIs) or TCA.

Antidepressants with relatively short half-lives are desirable for people with multiple comorbidities and complex, multiple-drug regimens because they allow for once-daily dosing. A short half-life enables physicians to switch more rapidly and safely to an alternative antidepressant if treatment fails or if unfavorable drug reactions occur.

Paroxetine and fluvoxamine are more quickly cleared from the body than the other SSRIs.

The possible slower onset of antidepressant action of fluoxetine may be owing to a longer time taken to achieve therapeutic plasma concentrations. In situations where the speed of onset of therapeutic effect is particularly important, such as in severe depression, fluoxetine may not be the SSRI of choice. Patients in whom the long half-life may have advantages (and therefore for whom fluoxetine should be considered) include those who are poorly compliant and those in whom administration less frequent than daily is contemplated.

Sertraline exhibits a sex- and age-dependent half-life. In men, the half-life is approximately 30% shorter (22.4 hr) than in females or the elderly (32.1-36.7 hr).

References
  • Celexa Prescribing Information Celexa.com, Forest Pharmaceuticals, Inc.
  • Lexapro Prescribing Information Lexapro.com, Forest Pharmaceuticals, Inc.
  • Paxil Prescribing Information – Paxil.com, GlaxoSmithKline
  • Prozac Prescribing Information Prozac.com, Eli Lilly and Company
  • Zoloft Prescribing Information – Zoloft.com, Pfizer Inc.
  • 1. Side-effect profile of fluoxetine in comparison with other SSRIs, tricyclic and newer antidepressants: a meta-analysis of clinical trial data. Pharmacopsychiatry. 2005 Mar;38(2):69-77 MedLine
  • 2. Efficacy of escitalopram in the treatment of major depressive disorder compared with conventional selective serotonin reuptake inhibitors and venlafaxine XR: a meta-analysis. J Psychiatry Neurosci. 2006 Mar;31(2):122-31. MedLine
  • 3. Similar effectiveness of paroxetine, fluoxetine, and sertraline in primary care: a randomized trial. JAMA. 2001 Dec 19;286(23):2947-55
  • 4. Escitalopram is more effective than citalopram for the treatment of severe major depressive disorder Encephale. 2004 Mar-Apr;30(2):158-66. MedLine
  • 5. Fluoxetine versus sertraline and paroxetine in major depression: tolerability and efficacy in anxious depression. J Affect Disord. 2000 Aug;59(2):119-26.
  • 6. Labbate LA. Sex and serotonin reuptake inhibitor antidepressants. Psychiatr Ann. 1999;29:571–9.
  • 7. Meijer WE, Heerdink ER, van Eijk JT, Leufkens HG. Adverse events in users of sertraline: results from an observational study in psychiatric practice in The Netherlands. Pharmacoepidemiol Drug Saf. 2002;11:655–62. PubMed
  • 8. Fava M. Weight gain and antidepressants. J Clin Psychiatry. 2000;61(Suppl.):37–41. PubMed
  • 9. Fergunson JM. SSRI antidepressant medications: adverse effects and tolerability. Primary Care Companion. J Clin Pschiatry. 2001;3:22–7.
  • 10. Schatzberg AF, Haddad P, Kaplan EM, Lejoyeux M, Rosenbaum JF, Young AH, Zajecka J. Serotonin reuptake inhibitor discontinuation syndrome: a hypothetical definition. Discontinuation Consensus panel. J Clin Psychiatry. 1997;58
  • 11. Westenberg HG, Sandner C. Tolerability and safety of fluvoxamine and other antidepressants. Int J Clin Pract. 2006 Apr;60(4):482-91. PubMed
  • 12. Rosenbaum JF, Fava M, Hoog SL, Ascroft RC, Krebs WB. Selective serotonin reuptake inhibitor discontinuation syndrome: a randomized clinical trial. Biol Psychiatry. 1998 Jul 15;44(2):77-87. PubMed
  • 14. Ian M. Anderson and J. Guy Edwards. Guidelines for choice of selective serotonin reuptake inhibitor in depressive illness Advances in Psychiatric Treatment (2001) 7: 170-180
  • 15. Fava M, Judge R, Hoog SL, Nilsson ME, Koke SC. Fluoxetine versus sertraline and paroxetine in major depressive disorder: changes in weight with long-term treatment. J Clin Psychiatry. 2000 Nov;61(11):863-7.PubMed
  • 16. Montejo-Gonzalez AL, Llorca G, Izquierdo JA, Ledesma A, Bousono M, Calcedo A, Carrasco JL, Ciudad J, Daniel E, De la Gandara J, Derecho J, Franco M, Gomez MJ, Macias JA, Martin T, Perez V, Sanchez JM, Sanchez S, Vicens E. SSRI-induced sexual dysfunction: fluoxetine, paroxetine, sertraline, and fluvoxamine in a prospective, multicenter, and descriptive clinical study of 344 patients. J Sex Marital Ther. 1997 Fall;23(3):176-94.PubMed
  • 17. Maina G, Albert U, Salvi V, Bogetto F. Weight gain during long-term treatment of obsessive-compulsive disorder: a prospective comparison between serotonin reuptake inhibitors. J Clin Psychiatry. 2004 Oct;65(10):1365-71.PubMed
  • 18. Bymaster FP, Zhang W, Carter PA, Shaw J, Chernet E, Phebus L, Wong DT, Perry KW. Fluoxetine, but not other selective serotonin uptake inhibitors, increases norepinephrine and dopamine extracellular levels in prefrontal cortex. Psychopharmacology (Berl). 2002 Apr;160(4):353-61.
  • 19. Nurnberg HG, Thompson PM, Hensley PL. Antidepressant medication change in a clinical treatment setting: a comparison of the effectiveness of selective serotonin reuptake inhibitors. J Clin Psychiatry. 1999 Sep;60(9):574-9.
  • 20. Stahl SM. Not so selective serotonin reuptake inhibitors. J Clin Psychiatry 1998;59:343-4. Psychiatrist
  • 21. Owens JM, Knight DL, Nemeroff CB. Second generation SSRIS: human monoamine transporter binding profile of escitalopram and R-fluoxetine. Encephale. 2002 Jul-Aug;28(4):350-5. PubMed
  • 22. Bolden-Watson C, Richelson E. Blockade by newly-developed antidepressants of biogenic amine uptake into rat brain synaptosomes. Life Sci. 1993;52(12):1023-9. PubMed
  • 23. Edwards JG, Anderson I. Systematic review and guide to selection of selective serotonin reuptake inhibitors. Drugs. 1999 Apr;57(4):507-33. PubMed
  • 24. Geretsegger C, Bo”hmer F, Ludwig M. Paroxetine in the elderly depressed patient: randomized comparison with fluoxetine of efficacy, cognitive and behavioural effects. Int Clin Psychopharmacol. 1994 Spring;9(1):25-9. PubMed
  • 25. Flament MF, Lane RM, Zhu R, Ying Z. Predictors of an acute antidepressant response to fluoxetine and sertraline. PubMed
  • 26. Clinical Pharmacology of SSRI’s. How SSRIs as a Group Are Similar.Sheldon H. Preskorn, M.D.
  • 27. Bandelow B, Behnke K, Lenoir S, Hendriks GJ, Alkin T, Goebel C, Clary CM. Sertraline versus paroxetine in the treatment of panic disorder: an acute, double-blind noninferiority comparison. J Clin Psychiatry. 2004 Mar;65(3):405-13 PubMed
  • 28. Montejo AL, Llorca G, Izquierdo JA, Rico-Villademoros F. Incidence of sexual dysfunction associated with antidepressant agents: a prospective multicenter study of 1022 outpatients. Spanish Working Group for the Study of Psychotropic-Related Sexual Dysfunction. J Clin Psychiatry. 2001;62 Suppl 3:10-21. PubMed
  • 29. Winokur A, Lexon N, Allen K, and et al. Sertraline administered for 8 weeks to depressed patients did not alter sleep architecture: a preliminary report. New Research Program and Abstracts of the 147th Annual Meeting of the American Psychiatric Association; May 24, 1994
  • 30. Cipriani A, Furukawa TA, Salanti G, Geddes JR, Higgins JP, Churchill R, Watanabe N, Nakagawa A, Omori IM, McGuire H, Tansella M, Barbui C. Comparative efficacy and acceptability of 12 new-generation antidepressants: a multiple-treatments meta-analysis. Lancet. 2009 Feb 28;373(9665):746-58.
  • 31. “Forest Laboratories Receives Patent Term Extension for Lexapro” Press release

Published: May 05, 2007
Last updated: August, 2009

Posted in Paroxetine, SSRIs | Tagged: , , , , , | 1 Comment »

GSK gives in – Last-minute deal in Avandia suit

Posted by shutah on January 31, 2011

A federal court in Philadelphia was all set to hear a liability lawsuit against GlaxoSmithKline today, but an 11th-hour settlement took that case right off the docket. GSK made a deal with the family of Avandia patient James Burford to resolve claims that the diabetes drug caused his fatal heart attack. GSK recently took a $3.5 billion charge for legal expenses, including new Avandia litigation filed in the U.S.

The settlement lets GSK avoid the risk of a jury trial, Matrix Corporate Capital analyst Navid Malik told Bloomberg. Investors had worried that a trial “could lead to substantial punitive damages,” Malik said. “GSK needs to successfully settle as many of these cases as possible.”

Two other suits brought by the same plaintiff attorneys were also settled. “GSK has resolved the Burford case scheduled for trial today in the U.S. District Court in Philadelphia, and all cases represented by attorneys Joseph Zonies and Thomas Cartmell,” GSK said in a statement, which also emphasizes that, “GSK continues to stand behind the safety and efficacy of Avandia when used appropriately and according to its label.”

Avandia’s safety, particularly its potential link to heart attack risks, has been under debate for several years, and GSK has already resolved some 10,000 liability suits with a $460 million settlement. In September, European regulators banned Avandia, saying its risks outweighed its benefits. The FDA stopped short of withdrawing the drug, but sharply restricted its use, and GSK agreed to stop promoting it. About 2,000 more lawsuits remain outstanding.

This SUCKS!!!  Not for the Claimants, I’m thrilled for them.  But GSK have ‘settled’ the case, thereby allowing them to walk away from their responsibilities by not having to testify in Court.

Their statement … “GSK continues to stand behind the safety and efficacy of Avandia ….” shows them to be lily-livered, cold-hearted bureaucrats with a seemingly bottomless well of money to throw about.  I’ll bet GSK doesn’t have the balls to ‘fess up to their errors when it comes to the SSRI drugs they ‘peddle’ around the World!!!  Boo, Hiss GSK!!!!

Posted in GlaxoSmithKline | Tagged: , , , , , , , | Leave a Comment »

“Pharmageddon” by Charles Medawar

Posted by shutah on January 29, 2011

Taken from http://www.socialaudit.org.uk

Pharmageddon has been defined as, “the prospect of a world in which medicines and medicine produce more ill-health than health, and when medical progress does more harm than good”. We see the need to investigate and explore that risk and to identify the factors and features that describe it.

Pharmageddon embraces the arguments of Ivan Illich (1976) but extends his focus. He warned of the risks of medicalisation, the generally dehumanising and damaging effects of professional interventions: “the medical establishment has become a major threat to health“. Beyond direct drug injury (clinical iatrogenesis), he was concerned about the ill-effects of medicine on culture and community, “the paralysis of healthy responses to suffering, impairment and death” that resulted from “the expropriation of health“.

But since Illich wrote, the whole shape of medicine has changed – both the knowledge base and its applications – and the pharmaceutical industry has come to dominate the medical establishment and the thrust and ethos of drug research, regulation, prescribing, availability and use.

The values of the market increasingly count. Now the leading companies, ‘the Pharmas’, have the driving influence on lifestyle, well-being and health outcomes. Their interests and investments have a major impact on the nature and availability of drug treatments, and on the essence and conduct of medicine, worldwide.

The surge towards globalisation since the 1990s has placed the pharmaceutical industry where it is today. The Pharmas are now centred in the USA – which represents half the global market – and mainly reflect American health values and ways of doing things. The Pharmas are also major instruments of US foreign policy, and their interests are well defended as such.

Pharmageddon stands for the lament that the state of world health represents a colossal waste of what medicine and medicines could accomplish, by structurally harnessing all the talent, energy and commitment that is there. Increasingly this is not happening, which is neither morally defensible, nor in the best interests of our future. It is damaging to the climate of health, the oxygen of community and the core of personal well-being.

Pharmageddon is marked by the contrast between over-medication and drug deprivation; it also implies a strong causal link between the two. Under-medication in poorer communities, and over-medication in richer ones, are connected as closely as obesity and malnutrition, like two sides of the same coin.

Intensive drug marketing and excessive drug consumption has produced an industry whose capacity to innovate and provide is compromised, and whose viability seems increasingly to depend on systematic exaggeration of drug benefits and suppression of evidence of risks and harm. In place of transparency, the industry has now largely taken into its own hands the role of providing information to the public and professionals, filling the air with messages about health priorities, expectations and needs. The net result is a drug supply system that starves national health and sustains global health deprivation.

Outside the major drug markets, populations suffer and die because drugs they need are completely unaffordable, because trade rules block access, and/or for lack of relevant innovation. Elsewhere, the obsession with drug treatment, health observance and disease awareness, is producing nothing like the desired effects. The USA exemplifies this trend: it is beset by diseases of affluence, most obviously by obesity, with diabetes and related complications. But in spite, and no doubt also because, of all the treatment options, fewer than one in twenty citizens manages to maintain a normal weight, eat a nutritious diet, take adequate exercise and not smoke.

For all this, the notion of Pharmageddon may still seem almost inconceivable – as did the risk and threat of Climate Change, just a few years ago. It is natural to deny risks when the misery in prospect results from so much good intent and great talent, and from the enjoyment of huge benefits, valued freedoms and countless goods. And because medicines are especially precious goods, the idea of Pharmageddon offends personal and vested interests alike.

Parallels seem to exist between health and environmental catastrophe. The issues compare to the relationship between a car journey and Climate Change: they are inextricably linked, but not remotely connected in scale or relevance in the average driver’s mind. Just as Climate Change seems inconceivable as a journey outcome, so most personal experience of medicines flatly contradicts the notion of Pharmageddon.

As clinical practitioners, or individual consumers with access to medicines, most people have seen, felt, witnessed and/or imagined their sometimes miraculous effects and results. But, to pursue the analogy, the risk of Pharmageddon is to do with the way in which all drug travel changes the climate of health, even when so many individual drug journeys seem vital or worthwhile.

Both because and in spite of all the benefits of good medicine, it seems crucial to consider whether, collectively, we are rapidly losing sight and sense of health. Increasingly it seems we are. At least we need to challenge the dominant fallacy that drugs more and more resemble magic bullets and offer ever better solutions for the main trials of life.

At the same time, we need to accept that Pharmageddon is not simply the product of malevolence, but the natural outcome of something like a ‘conspiracy of goodwill’ – a universe driven by self interest, but dominated by a complex of corporate bodies all competing to survive. If Pharmageddon seems to beckon, it is in spite of what everyone wants, not because of it.

That also applies to the Pharmas. All might be well if their products matched promise and met genuine health needs. In fact, the Pharmas are panicked by this huge shortfall and become more predatory, gluttonous, devious and oppressive, to try to compensate for it. Health outcomes drift further and further away from mainstream thinking; excessive promotion, data suppression and falsification, secrecy, bribery, fraud and deep conflicts of interest are increasingly revealed.

The consequences go far beyond the drug disasters that make the headline news.Pharmageddon implies that we have now arrived at a tipping point where leading companies devote their main energies to marketing lifestyle products, rather than on finding ways of meeting real medical needs. The brave new world in prospect is one in which commercial imperatives trump health priorities, when Pharmas and followers systematically change our understanding and experience of what it means to be human, flattening the distinctions between cultures, degrading the clinical arsenal, and developing vast numbers of drugs, most not needed and all purporting to be best. The net result is not only therapeutic disappointment, but also crushing pressures that no public health system could ever survive.

Many people have concerns about many different flaws in the present system of pharmaceutical medicine, but what do they all add up to? Our starting point is simply that the word, Pharmageddon, may mean something important and deserves to exist, if only as a description of forest rather than trees.

The etymology seems to fit. Pharmageddon conveys the idea of a battle between health and ill-health, right and wrong and for better or worse. It also challenges the tendency to take for granted that progress in pharmaceutical medicine leads naturally to better health. Armageddon was “the great symbolic battlefield of the Apocalypse, scene of the final struggle between good and evil”. Apocalypse (APOKALYPSIS) literally means the lifting of the veil, “a term applied to the disclosure to certain privileged persons of something hidden from the mass of humankind…” (Wikipedia, 2007).

The time has come to lift the veil: the broader significance of the risks must be explored and revealed. If Pharmageddon is part of any future reality, we all need to know.

 

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