HEART DIAGRAMS

The info here is fairly easy to follow, but at some points ( particularly if you are reading the "Label Excerpts" section, in which I include explanations of all unfamiliar sounding terms) it would be helpful to have some understanding of heart structure and terminology. A lot of the heart problems involve the electrical process that creates a heart-beat, for example, or specific parts of the heart. I suggest checking out these two diagrams and perhaps keeping them at your side (right click and select "Open in New Window") as you read.

[the heart]
[the heart's electrical system]
[from webmd.com]

SUMMARY OF RISKS

Rapid heart-beat is listed by [Risperdal.com] as one of the MOST COMMON side effects of Risperdal. Add to this all the other associated heart and respiratory risks, and the result is downright disturbing. The problems (such as changes in respiration, heart-rate, and/or blood pressure) are not only listed as an independent set of side effects; they are also inherent in some of the extrapyramidal symptoms (such as Neuroleptic Malignant Syndrome, oculogyric crisis, etc). To keep it simple, though, the main heart problems that come up repeatedly throughout the label, and thus are definitely and uncontestedly associated with RISPERDAL usage, are (1) orthostatic hypotension, and (2) arrhythmias (the most prevalent being tachycardia and lengthened QT-interval).

ORTHOSTATIC HYPOTENSION = (aka postural hypotension) "an extreme drop in blood pressure that may occur when a person stands up suddenly and the blood pools in the blood vessels of the legs," (thus reducing the amount of blood carried back to the heart, thus reducing the amount of blood pumped OUT of the heart). "By definition, the drop in blood pressure must be greater than 20 mm of mercury during contraction of the heart muscles (systole) and more than 10 mm of mercury during expansion of the heart muscles (diastole)." [webmd].

ARRHYTHMIA = (aka dysrhythmia) irregular heart-beat, but it is more complicated than that. [Webmd] lists 14 different kinds of arrhythmias. I highly suggest checking out their info [here].

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 [see below...]. 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."

TACHYCARDIA = type of arrhythmia. Most simply put, a rapid heart beat - but there are several distinct kinds: Paroxysmal supraventricular tachycardia (PSVT), of which there are two types (accessory path tachycardias and AV nodal reentrant tachycardias), and, Ventricular tachycardia (V-tach). Risperdal can bring on any of these types of tachycardia, but it is the final type, v-tach, that a lengthened QT-interval (which can also be brought on by Risperdal) increases the risk for. V-tach is "a rapid heart rhythm originating from the lower chambers (or ventricles) of the heart. The rapid rate prevents the heart from filling adequately with blood; therefore, less blood is able to pump through the body. This can be a serious arrhythmia" [webmd]. For definitions of the other types, please visit webmd [here]. In 6-8 week controlled clinical trials, 3% of people taking Risperdal doses of 10 mg/day or more and 5% of people taking 16 mg/day or more developed tachycardia. The percentage of people taking a placebo who developed tachycardia was zero.

If you're thinking that an occasional rapid heart-beat or low blood pressure here or there is no big deal, think again. Would you want yourself or someone you love to take a drug whose label is completely slapped over with warnings about how this drug can potentially cause a rapid or irregular heart-beat and/or high blood-pressure, AND possibly mess with the detailed, electronic impulses and timing that regulates every single beat of one's heart?

All that, and without even beginning to go into detail about some of the less common but just as alarming possible side effects, such as myocardial infarction (heart-attack), stroke or stroke-like events, sudden death and/or cardiopulmonary arrest, or aspiration ["vomiting material from your stomach and then breathing it into your lungs," webmd].

I beg of you, PLEASE consider carefully.... or this entire website is a waste.

ADDENDUM:

Regarding lengthened QT-interval... In July of 2000, another atypical antipsychotic drug, Zeldox, was approved by the FDA, who had initially called it "non-approvable." For what reason? -- "The FDA initially decided not to approve Zeldox based on its prolonging affect on the QT interval." Yet, two years later, they changed their minds (though the drug remained unchanged). Apparently, "[w]hile Zeldox may not be the safest atypical antipsychotic alternative, there is a lot of data to suggest that doctors are willing to accept a risk of rare heart-related events for an additional treatment option, committee members almost unanimously concluded." (I can't help but wonder how great of an influence MONEY might have had on turning over this two-year old decision, considering how rich drug companies are, but that's just a totally random suspicion.) In relation to RISPERDAL?... "The research showed that Zeldox's affect on the QT interval was not much different from the other drugs." [Expert FDA Panel Backs Schizophrenia Drug It Once Rejected].

LABEL EXCERPTS

This section consists solely of label excerpts concerning the serious risks of Risperdal. In other words, it is the source for everything I have already said about what heart/risperatory problems Risperdal may cause. Please do not feel that it is necessary to read all this, as I have already, above, summarized and explained all the ramifications of these bits of text. Like a bibliography or set of foot-notes, however, it is here for those who wish to read it.

Personally, I would suggest at least skimming it, just to get a grasp of the bigger picture, of how extremely prevalent the above-mentioned (and other) risks are. Some of the less major risks may SEEM insignificant, yet, at the same time, they are often a symptom of or are otherwise connected to the more major problems already mentioned. Please always keep in mind that ANY risk involving vital signs (heart function or respiration) is, by its very nature, potentially fatal.

[source: label, revised April 2003]. Note: I have added bracketed words in red to describe preceding terms that are bold. All medical info is from [webmd], but since I do not have time or space to provide detailed explanations of EVERYTHING, I suggest that if you have further questions, you go there yourself and look up terms. It is a very helpful site.

EXCERPTS:

[under WARNINGS - NEUROLEPTIC MALIGNANT SYNDROME]: "Clinical manifestations of NMS" include "evidence of autonomic instability (irregular pulse or blood pressure, tachycardia [see part one], diaphoresis [excessive sweating], and cardiac dysrhythmia [see part one].)

[under WARNINGS - CEREBROVASCULAR ADVERSE EVENTS, INCLUDING STROKE, IN ELDERLY PATIENTS WITH DEMENTIA]: "Cerebrovascular adverse events (e.g., stroke, transient ischemic attack ["ischemic" describes a type of stroke caused by a blocked or narrowed artery, as opposed to a a hemorrhagic stroke, which occurs when "an artery in the brain leaks or bursts and causes bleeding inside the brain tissue or near the surface of the brain" ], including fatalities, were reported in patients (mean age 85 years; range 73-97)".

[under WARNINGS - POTENTIAL FOR PROARRHYTMIC EFFECTS]: "Risperidone and/or 9-hydroxyrisperidone appear to lengthen to QT-interval [see part one] in some patients ... Other drugs that lengthen the QT interval have been associated with the occurence of torsades de pointes, a life-threatening arrhythmia [see part one]. Bradycardia, electrolyte imbalance, concomitant use with other drugs that prolong QT, or the presence of congenital prolongation in QT can increase the risk for occurence of this arrhythmia."

[under PRECAUTIONS - ORTHOSTATIC HYPOTENSION]: Risperdal "may induce orthostatic hypotension [see part one] associated with dizziness, tachycardia [see part one], and in some patients, syncope [fainting; can be a warning sign of arrhythmia] ... Risperdal should be used with particular caution in patients with known cardiovascular disease ... cerebrovascular disease, and conditions which would predispose patients to hypotension, e.g., dehydration and hypovolemia."

[under PRECAUTIONS - DYSPHAGIA]: Esophageal dysmotility [inability of the esophagus to move food down toward the stomach] and aspiration ["vomiting material from your stomach and then breathing it into your lungs"] have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality in patients with advanced Alzheimer's dementia."

[under PRECAUTIONS - USE IN PATIENTS WITH CONCOMITANT ILLNESS]: "Risperdal has not been evaulated or used to any appreciable extent in patients with a recent history of myocardial infarction [heart attack] or unstable heart disease. Patients with these diagnoses were excluded from clinical studies during the product's premarket testing. The electrocardiograms of approximately 380 patients who received RISPERDAL and 120 patients who received placebo in two double-blind, placebo-controlled trails were evaulated and the data revealed one finding of potential concern, i.e., 8 patients taking RISPERDAL whose baseline QTc interval was less than 450 msec were observed to have QTc intervals greater than 450 msec during treatment; no such prolongations were seen in the smaller placebo group. ... Because of the risks of orthostatic hypotension and QT prolongation, caution should be observed in cardiac patients." [see part one for info on ORTHOSTATIC HYPOTENSION and LENGTHENED QT-INTERVAL].

[under INFO. FOR PATIENTS - ORTHOSTATIC HYPOTENSION]: "Patients should be advised of the risk of orthostatic hypotension" [see part one].

[under DRUG INTERACTIONS]: "Because of its potential for inducing hypotension [see part one], RISPERDAL may inhance the hypotensive effects of other therapeutic agents with this potential".

[under GERIATRIC USE]: Warns that "elderly patients exhibit a greater tendency to orthostatic hypotension" [see part one] so that "Monitoring of orthostatic vital signs should be considered in patients for whom this is of concern."

[under TABLE 1 - INCIDENCE OF TREATMENT-EMERGENT ADVERSE EVENTS IN 6 to 8-WEEK CONTROLLED CLINICAL TRIALS]: Tachycardia [see part one] was reported by 3% (group size of 324) of those taking 10 mg/day or less, and by 5% (group size of 77) of those taking 16 mg/day. For the placebo group, the rate of tachycardia was zero percent.

[under OTHER ADVERSE EVENTS]: A Cochran-Armitage test revealed a positive trend for, among other adverse effects, orthostatic dizziness [see part one] and palpitations ["fluttering in your chest," a symptom of TACHYCARDIA (see part one)] meaning that as the dosage levels went up, the incident of these particular side effects went up).

[under VITAL SIGN CHANGES]: "RISPERDAL is associated with orthostatic hypotension [see part one] and tachycardia" [see part one].

[under ECG CHANGES]: The electrocardiograms of approximately 380 patients who received RISPERDAL and 120 patients who received placebo in two double-blind, placebo-controlled traislw ere evaulated and the data revealed one finding of potential concern, i.e., 8 patients taking RISPERDAL whose baseline QTc interval was less than 450 msec were observed to have QTc intervals greater than 450 msec during treatment (see WARNINGS). Changes of this type were not seen among about 120 placebo patients" [see part one about LENGTHENED QT-INTERVAL].

[under OTHER EVENTS OBSERVED DURING THE PREMARKETING EVAULATION OF RISPERDAL - RESPIRATORY SYSTEM DISORDERS]: (Rare means occurs in less than 1/1000 patients.) "Rare: aspiration" [vomiting material from your stomach and then breathing it into your lungs].

[under OTHER EVENTS OBSERVED DURING THE PREMARKETING EVAULATION OF RISPERDAL - CARDIOVASCULAR DISORDERS]: (Infrequent means occurs in 1/100 to 1/1000 patients.) "Infrequent: palpitation ["fluttering in your chest," a symptom of TACHYCARDIA (see part one)], hypertension [low blood pressure], hypotension [see part one], AV block [aka congenital heart block, "characterized by interference with the transfer of electrical nerve impulses (conduction) that regulate the normal rhythmic pumping activity of the heart muscle (heart block)"], myocardial infarction [heart attack]. Rare: ventricular tachycardia [see part one], angina pectoris [a muscle cramp in the heart, experienced as squeezing chest pain; "develops when the heart muscle does not receive enough oxygen for its needs from the [coronary] arteries," thus making it a form of coronary artery disease], premature atrial contractions ["early extra beats that originate in the atria (upper chambers of the heart)"], T wave inversions [I believe this involves the electric current in the heart], ventricular extrasystoles [I believe this involves the timing of the out-take/in-take of the heart, ST depression [I believe this involves the electric current in the heart], myocarditis [inflammation of the heart muscles].

[under OTHER EVENTS OBSERVED DURING THE PREMARKETING EVAULATION OF RISPERDAL - POST-INTRODUCTION REPORTS]: "Adverse events reported since market introduction which were temporarily (but not necessarily causually) related to RISPERDAL therapy, include the following: anaphylactic reaction [sudden, severe allergic reaction that occurs when you are exposed to a substance that your body was sensitized to during a previous exposure ... The reaction causes a sudden release of chemicals, including histamines, from cells in the blood and the body's tissues. These chemicals dilate the blood vessels, lowering blood pressure, and they cause the blood vessels to leak fluid, leading to hives and swelling, especially around the face and throat. The chemicals also act on the lungs, causing an asthmatic reaction -- that is, causing the lung's airways to constrict, thus obstructing breathing"], angiodema [I believe this is another type of allergic reaction], apnea ["episode of not breathing"], atrial fibrillation ["most common form of irregular heartbeat (arrhythmia)." When "abnormal electrical impulses cause the upper chambers of the heart (atria) to fibrillate, or quiver, resulting in irregular and rapid beating of the ventricles, the heart's main pump. As a result, the heart pumps less efficiently, reducing blood flow to the body and to the heart muscle itself." Furthermore, "people with atrial fibrillation are at increased risk for life-threatening strokes"], cerebrovascular disorder, including cerebrovascular accident [stroke], hyperglycemia [high blood sugar], diabetes millitus aggravated, including diabetic ketoacidosis [emergency condition associated with type 1 diabetes. Without enough insulin, the body begins to use fat for energy, converting it into ketones, which then build up and raise the acid level of your blood. Then, "an increase in PH of blood can cause dangerous abnormalities in various pathways in the body and instability of many of the body systems like the heart."], intestinal obstruction, jaundice, mania, pancreatitis, Parkinson's disease aggravated, pulmonary embolism "sudden blockage of an artery in the lung. Once the artery is blocked, usually by one or more blood clots, oxygen levels drop, and blood pressure in the lungs rises. Pulmonary embolism caused by large clots can cause sudden death, usually within 30 minutes of when symptoms begin. Smaller clots may cause permanent damage to the heart and lungs."]. There have been rare reports of sudden death and/or cardiopulmonary arrest in patients receiving RISPERDAL."

[under OVERDOSAGE - HUMAN EXPERIENCE]: "Premarketing experience included eight reports of acute RISPERDAL (risperidone) overdosage with estimated doses ranging from 20 to 300 mg and no fatalities. In general, reported signs and symptoms were those resulting from an exaggeration of the drug's known pharmacological effects, i.e. drowsiness and sedation, tachycardia [see part one],and hypotension [see part one], and extrapyramidal symptoms. One case involving an estimated overdosage of 240 mg, was associated with hypoatremia, hypokalemia metabolic imbalance characterized by extremely low potassium levels in the blood. It is a symptom of another disease or condition, or a side effect of diuretic drugs. The body needs potassium for the contraction of muscles (including the heart), and for the functioning of many complicated proteins (enzymes), prolonged QT [see part one], and widened QRS [I believe this is similar to lengthened QT interval, in that it involves the electrical process of a heartbeat, and/or the electrical wave pattern on an ECG]. Another case, involving an estimated overdose of 36 mg, was associated with a seizure. Postmarketing experiences includes reports of acute RISPERDAL overdosage, with estimated doses up to 360 mg. In general, the most frequently reported signs and symptoms are those resulting from an exaggeration of the drug's known pharmacological effects, i.e. drowsiness and sedation, tachycardia and hypotension.Other adverse events reported since market introduction which were temporally (but not necessarily causally) related to RISPERDAL overdose, include prolonged QT interval [see part one], convulsions, cardiopulmonary arrest, and rare fatality associated with multiple drug overdose.

[under OVERDOSAGE - MANAGEMENT OF OVERDOSE]: "Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias. If antiarrhythmic therapy is administered, disopyramide, procainamide, and quinidine carry a thereotical hazard of QT-prolonging effects that might be additive to those of risperidone. Similarly, it is reasonable to expect that the alpha-blocking properties of bretylium might be additive to those of risperidone, resulting in problematic hypotension. ... Hypotension and circulatory collapse should be treated with appropriate measures.

[under OVERDOSAGE - DOSAGE IN SPECIAL POPULATIONS]: "The recommended initial dose is .5 mg BID in ... patients either predisposed to hypotension or for whom hypotension would pose a risk." [Usual initial dose is 1 mg BID.]