Before getting into the basic, physical properties, uses and risks of this drug, please bear with me a minute, and read this section first. Thank you.

RISPERDAL in the news:

July 21, 2004: In a two-page letter to doctors, Janssen (producers of RISPERDAL) admitted to misleading doctors and minimizing the potentially fatal risks (such as heart problems, stroke, or sudden death) of Risperdal. As late as November 10, 2003, for example, Janssen had claimed that Risperdal did not increase the risk of diabetes, though the opposite was true. In April 2004 Janssen received a letter from the U.S. Dept of Health & Human Services warning them that Risperdal did indeed increase the risk of hyperglycemia-related and diabetic adverse effects. Lastly, the same week of Janssen's confession, the Miami Herald had run an article about Risperdal's causing a handful of boys to develop lactating breasts. [namiscc.org, and various other sources].

Around 2003: RISPERDAL underwent a class action LAW-SUIT. The suit involved 37 incidents of stroke or stroke-like events in (I'm assuming mostly elderly) Risperdal patients, including 16 deaths. Johnson & Johnson issued a warning letter to Canadian health professionals in October 2002, but waited six whole months before issuing warning letters to American health professionals, and eventually did so only after they had run some tests to confirm the dangers. When the clinical trial (involving 764 Alzheimers patients) resulted in "29 cases of stroke and stroke-related events" and 4 deaths, Johnson & Johnson finally chose to tell American healthcare professionals about the risks. Eventually, changes were made to the Risperdal label to reflect these new risks. [drugrecall.com and various other sources]

[The Warning Letter to Canada // hc-sc.gc.ca] - sent by Janssen, October 2002
[Warning Letter to America // fda.gov] - sent by Janssen, April 2003
[Latest Label with recent changes high-lighted // fda.gov] - altered portion found at bottom of page six

IN SHORT, RISPERDAL has been in the news repeatedly, though these are the biggest stories. Now, in order not to overwhelm those who came to this site to learn the basics about the drug itself, I will cut this section short. At the bottom of the entire page, however, you can find a link to a page listing the sources for each of these stories, and also links to other, less major stories. I interrupted with this because I think it is important background info to bear in mind while reading the rest of the site.

THE BASIC FACTS ABOUT RISPERDAL:

RISPERDAL has only two intended, FDA approved purposes: Treating SCHIZOPHRENIA and treating "the most acute manic phases of BIPOLAR I DISORDER--the most severe form of the disease" [jnj.com]. Its label only lists Schizophrenia, but the FDA has approved it for both. Using it for ANY other purposes is called "Off-label" and is AT ONE'S OWN RISK.

RISPERDAL is a powerful, ATYPICAL, ANTI-PSYCHOTIC drug. Other than that, NO ONE EVEN KNOWS HOW IT WORKS. Its own label states that "The mechanism of action of RISPERDAL (risperidone) ... is unknown," but it is "proposed" to involve antagonism of dopamine and seratonin receptors. Like most powerful drugs, or drugs that are not well-understood, it is meant to be used only as a LAST-RESORT option for extreme cases of the psychotic disorders it was designed to cure (and in cases when the doctors have good reason to believe that it will work for a particular patient), NOT as the front-line treatment option it has become for anything from Schizophrenia to autism.

Apparently, all anyone knows is that it "is designed as a serotonin/dopamine antagonist," meaning that it "seems to block the action of serotonin and dopamine, two neurotransmitter chemicals in the brain," and somehow alleviates schizophrenia's positive and negative symptoms. As an atypical drug, it differs from conventional anti-psychotics in that conventional anti-psychotics (such as Haldol, Stelazine, and Prolaxin) seem primarly to affect only dopamine (instead of both dopamine and seratonin), seem only to affect the negative symptoms of schizophrenia, and have worse side effects [healthyplace.com].

RISPERDAL is NOT MEANT for LONG-TERM use. Its label clearly states that "The efficacy of RISPERDAL in schizophrenia was established in short-term (6 to 8 weeks) controlled trials of schizophrenia inpatients" and that "the physician who elects to use RISPERDAL for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient." Elsewhere, it again states that "The need for continued treatment should be reassessed periodically." RISPERDAL is a TEMPORARY solution, NOT a permanent cure.

I read parent postings talking about how their kid's been on Risperdal "for four years, since she was eight!" and so on. There is no way that kid's brain will develop normally after being on a powerful anti-psychotic drug throughout the childhood and puberty, such a crucial period for the development of the brain.

RISPERDAL is NOT MEANT FOR ANYONE UNDER 18. Under "Pediatric Use" the label contains a single line: "The safety and effectiveness of Risperdal in pediatric patients have no been established." What the label doesn't say is that "pediatric" does not just mean young children. Many drugs are not recommended for those twelve and under, but Risperdal is also not recommended for--as in, has not been sufficiently tested on and is therefore NOT approved for--anyone under 18, despite doctors prescribing it freely to teens and children alike.

Risperdal and children: I've found evidence of five clinical trials involving children. For the most part, they're hardly credible, for various reasons (low subject numbers, bad research techniques, or dubious results such as pre-adolescent girls beginning to lactate...) and only one was designed specifically to test the safety of Risperdal in children. Click [here] for details.

Concerning OFF-LABEL USE: Off-label use is when a doctor decides to ignore a drug's prescribed uses and/or suitable patients. According to [salon.com], "Once a drug is approved for use by the FDA for the treatment of a [single] specific medical condition, a doctor can legally prescribed it 'off label' for any purpose" (and to any patient). For Risperdal, off-label use includes giving Risperdal to ANYONE for health problems OTHER THAN Schizophrenia or Bipolar Mania, or to a child FOR ANY REASON, EVEN IF that child has Schizophrenia--which would be interesting, since the typical onset age of Schizophrenia is 17-19 years [salon.com]--and/or Bipolar Mania. This problem is very real, considering how it is now all the rage to prescribe Risperdal to children with autism. Anyone accepting a doctor's OFF-LABEL prescription should be aware that one is doing so at one's own risk (or at the risk of her/his children's lives). Check out ["Off-label Drugs Take their Toll" // realcities.com]

This is something people must make their own effort to be careful with, since apparently doctors do not feel the need to warn or even tell people a prescription is off-label. When I see web postings like "Has anyone ever heard of this new drug called Risperdal? I gave it to my 4 year old son for autism and it works wonders! But does it have any side effects?" I'm not sure whose ass I wish to kick more - the doctor's or the parent's. Hey parents: it is YOUR responsibility to ASK about what is going into your child's body!

SIDE EFFECTS one should know:

Tardive Dyskinesia (TD): Neuroleptic drugs like Risperdal can bring about "biochemical abnormalities" in the brain that result in Tardive Dyskinesia (TD), a potentially irreversible involuntary neurological movement disorder. It is also known as Linguofacial Dyskinesia, or Oral-facial Dyskinesia, because the involuntary movement occurs with the face, lips, mouth and tongue. Examples of TD include "speech or swallowing problems, lip smacking or puckering, loss of balance, cheek puffing, rapid or wormlike tongue movements, shakiness or trembling, shuffling walk, slow movements, arm or leg stiffness, uncontrolled chewing movements, and uncontrolled movements of hands, arms, or legs." [webmd].

With Risperdal, "the risk of developing tardive dyskinesia and the likelihood that it will be irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs adminstered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses" [source: Risperdal label]. There is no known treatment for TD. Generally, if TD symptoms appear, patients should quit Risperdal. However, neuroleptic drugs can cause but simultaneously supress TD symptoms, so that no one is aware that the patient is developing TD until it is too late.

Neuroleptic Malignant Syndrome (NMS): Antipsychotic drugs like Risperdal can cause NMS, a "potentially fatal symptom complex." Manifestations of NMS include: "hyperpyrexia [abnormally high fever], muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia [rapid heartbeat; see heart section], diaphoresis [severe perspiration], and cardiac dysrhythmia [abnormal heart rhythm]. Additional signs may include elevated creatine phosphokinase [an enzyme; "Low levels of these enzymes are normally found in your blood, but if your heart muscle is injured, such as in a heart attack, the enzymes leak out of damaged heart muscle cells and their levels in the bloodstream rise," [webmd], myoglobinuria (rhabdomyolysis) [unsure what this is], and acute renal failure [kidney failure]. Once a patient gets NMS, doctors can treat those of the individual symptoms that have known treatments, but "there is no general agreement" for treating or curing the NMS as a whole [source: Risperdal label]. Bracketed info from [webmd.com].

Heart Problems: Risperdal's label is absolutely packed with warnings about the drug's potential to cause numerous, serious heart problems. In fact, it seems that heart problems are THE single biggest risk associated with Risperdal use, yet they are often mentioned in such a disorganized way that it seems Janssen does not really want us to NOTICE how bad the situation is. Along with being their own set of risks/side-effects, heart/respiration problems (changes in respiration, heart-rate, and/or blood pressure) are inherent in some of the extrapyramidal symptoms (such as Neuroleptic Malignant Syndrome, oculogyric crisis, etc). [Risperdal.com] even lists rapid heart-beat as one of the MOST COMMON side-effects. On the label, the most repeatedly-mentioned heart-related problems are (1) hypotension (low blood pressure) and (2) two types of arrhythmias: lengthened QT-interval, and tachycardia (fast heartbeat). These things are a lot more complicated than they sound though.

Please click [here] for details. I worked really hard on the heart page because for me, it is the one of the most crucial portions of this site, and something I really want to warn people about.

EXTRAPYRAMIDAL SYMPTOMS (EPS) are among Risperdal's MOST COMMON side-effects. EPS include a range of possible side-effects falling under the Body System category "Central and Peripheral Nervous System" and which are united by their shared similarity to Parkinson's disease. According to the label, they include "tremor, dystonia, hypokinesia, hyperkinesia, oculogyric crisis, ataxia, abnormal gait, involuntary muscle contractions, hyporeflexia, akathisia, and extrapyramidal disorders." [Click here] for definitions of these afflictions. Two very serious afflictions, Neuroleptic Malignant Syndrome (change in breathing and heart-rate) and Tardive Dyskinesia (involuntary movements), also fall under EPS, making the VERY HIGH RATE of EPS even more alarming.

In the clinical trial described on the label, 17% of those taking 10 mg/day or less developed EPS. Among other side effects, this percentage was topped only by insomnia and agitation. In the 16 mg/day group, 34% developed EPS. This was the highest percentage on the side-effects chart, the next highest being agitation, at 26 percent. In the placebo group, 16% developed EPS (which is only 1 percent different from the 17% of the 10 mg/day or less group). However, the label specifically stresses that "Although the incidence of [EPS] does not appear to differ for the '10 mg/day' group and placebo, the data for individual dose groups in fixed dose trials do suggest a dose/response relationship." It then proves this with two charts.

One more time... RISPERDAL is a LAST RESORT:

RISPERDAL is a powerful anti-psychotic drug, with serious or even FATAL side-effects, and should only be used by those who TRULY need it (such as those who actually HAVE psychotic illnesses...) In consideration of the risks, Risperdal's label warns that "Chronic anti-psychotic treatment should generally be reserved for patients who suffer from a chronic illness that (1) is known to respond to anti-psychotic drugs and (2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical result should be sought. The need for continued treatment should be reassessed periodically."

And yes, its being a LAST-RESORT option for sufferers of schizophrenia and bipolar mania DOES greatly conflict with its being used as a "front-line" (first-resort) treatment option for all sorts of conditions, and with [risperdal.com] proudly declaring it "The most frequently prescribed anti-psychotic medication in the U.S." Keep in mind that a drug's being widely prescribed is NOT indicative of that drug being widely NEEDED -- it can also indicate prescriber and/or prescribee ignorance, successful marketing techniques (such as how Janssen waited to warn the U.S. about known fatal risks until it had run more tests, preferring to risk lives rather then sales revenue) and a country that loves being over-medicated. When your own life or the lives of people you love are at risk, I hope you will take everything you now know into consideration, and choose wisely.

questions? comments?
contact me via e-mail at jori.lindley@gmail.com