Important News

Important News

Twelve years into the battle, I have finally been validated. A recent (Jan 15, 2009) article in the New England Journal of Medicine entitled "Atypical Antipsychotics and Sudden Cardiac Death - How Should We Manage the Risk?" has stated precisely what I've been fighting to get across to people for the last decade. It is amazing to me: it is everything on this website of mine, in a nutshell.

Below, you will find my very brief summary of it, followed by highlights of the article's key points in its own words.

SUMMARY:

Atypical antipsychotics like Risperdal are definitely associated with sudden cardiac death. This could be because they can prolong the QT interval.

It makes no sense that it took so long (two decades) to figure this out...

The risk is higher for children and the elderly, and is dose-dependent.

The benefits of Risperdal in children, the elderly, or people taking it for off-label reasons (i.e. something other than schizophrenia or bipolar mania) have not been established; therefore, the unproven benefit is not worth the proven risk.

Even for people who need to be on it, a system of careful monitoring of their cardiac health, similar to the monitoring required for people on Clozapine, must be put into place.

Until that happens, "the use of these drugs should be reduced sharply."

KEY POINTS, QUOTING THE ARTICLE

"The effect of most antipsychotic medications on the electrophysiology of the heart has been long known, and several studies have shown an association between older, conventional (typical) [Risperdal is atypical] antipsychotic medications ... and death, including sudden cardiac death."

Compared typical to atypical antipsychotics [including Risperdal], the authors found that "the risk for sudden cardiac death is at least as high for atypical antipsychotic medications as it is for conventional agents, and that it is dose-dependent for all agents."

[side note regarding dosage: a huge issue with American Big Pharma is that standard doses are often dangerously higher than called for, so that a company can claim a standard (bigger) dose of their drug is "more efficient" than a standard (smaller) dose of another company's drug. Also, doses are designed for big healthy 25 year old white males, which sucks for women and children and the elderly, who weigh less and whose bodies work differently]

The results of their study "correlate with the relative respective potential of these drugs to cause prolongation of the QT interval."

[from another part of my website: LENGTHENED QT-INTERVAL = type of arrhythmia. "The QT interval is the area on the electrocardiogram (ECG) that represents the time it takes for the heart muscle to contract and then recover, or for the electrical impulse to fire impulses and then recharge. When the QT interval is longer than normal, it increases the risk for "torsade de pointes," a life-threatening form of ventricular tachycardia. Long QT syndrome is an inherited condition that can cause sudden death in young people." [webmd]. Elsewhere, webmd reiterates that "although it is not fully known, it is thought that increasing the QT interval leads to abnormal and potentially fatal heartbeats."]

"It is striking that it took so long to establish the elevated risk associated with atypical antipsychotic medications given that the first agent in this class (clozapine) entered the U.S. market in 1989." [maybe cuz Jansen's so good at bullshitting like their drug isn't killing people? ...]

"Ray et al. present a comprehensive study that makes a clear case for the increased risk of sudden cardiac death associated with all anti-psychotic drugs."

"Much of [atypical antipsychotics'] use is in vulnerable populations and outside the labeled indications [="off-label"], including the use in children and in the elderly with dementia, and there is much less evidence of efficacy [= effectiveness] in these populations. In the absence of clearly established benefits for many of these patients, the risk of a fatal side effect is not acceptable. For these patients, the use of antipsychotic medications should be reduced sharply, perhaps by requiring an age-dependent justification for their use. Educating prescribers on the benefit-risk relationship of such drugs has also proved effective."

They should ONLY be prescribed "when there is clear evidence of benefit, such as schizophrenia and bipolar disorders. [i.e. NO MORE OFF-LABEL!] In patients for whom the drug is truly indicated, a small risk of rare but fatal side effects may be acceptable until new medications with a safer cardiac risk profile are developed."

Clozapine was the first atypical antipsychotic to enter the market. It's actually pretty effective, but because it can cause death from agranulocytosis, "[a]n elaborate risk-management program has been in place for almost two decades for clozapine, requiring a close monitoring of white cell counts before a prescription can be refilled." The authors recommend something similar for these dangerous atypical antipsychotics, advising that "in our view if an antipsychotic agent is necessary, it seems reasonable to obtain an electrocardiogram before and shortly after initiation of treatment with an antipsychotic drug. This modest effort could enable each patient starting on a high-dose antipsychotic to be screened for existing or emergent prolongation of the QT interval."

Another study showed that "3% of patients with schizophrenia (mean age, 40 years) who were treated with risperidone and quetiapine had prolongation of the QT interval. The risk was doubled (6%) among patients with dementia (mean age, 78 years); these proportions are probably even higher among elderly users of high-dose drugs."

"We think that once prolongation of the QT interval is detected, a reduction or discontinuation of the drug should be attempted, concurrent medications should be examined for known interactions, other risk factors for sudden cardiac death should be reduced, and follow-up electrocardiograms should be obtained."

The authors again press for a "formal model for decision analysis" similar to the one for Clozapine, and conclude their article with the warning:

"Until then, in patient populations for whom the evidence of efficacy of antipsychotic drugs is limited [i.e. children, the elderly, and anyone using it for something other than schizophrenia or bipolar disorders] and the risk of a fatal side effect is clear, prudence would suggest that the use of these drugs should be reduced sharply."

Unfortunately, Risperdal's website proudly announces that it can be used "for the treatment of irritability associated with autistic disorder in children ages 5-17," even though it's never been officially tested for children (as far as I know), or for that purpose. Regarding dosage, I have just made the disturbing discovery that there is a now a once-every-2-weeks form of Risperdal called Risperdal Consta. This follows a general trend of high-powered once a week or once every two week forms of pills that people would otherwise take daily or multiple times daily (safer and healthier than beating your body with a 2-week dose in one sitting). The battle never ends...

I have uploaded the article. At just three pages, it is "short, sweet, and to the point," so I suggest you all download it and read it yourself.

Schneewiess, Sebastian, M.D., Sc.D., and Jerry Avorn, M.D. (2009) "Antipsychotic Agents and Sudden Cardiac Death - How Should We Manage the Risk?" in New England Journal of Medicine v.360(3), pp. 294-296.