A person’s health can be judged by which he takes two at a time—pills or the stairs.

                                                                    Joan Welsh

Side Effects of Psychotropic Medication

In a world where medications are increasingly being prescribed as treatment for mental health disorders, a patient must consider the balance between the drug’s benefit and its negative side effects.  Side effects also have implications for interpretation of studies of medication effectiveness.  For example, the most common side effects for anti-depressant and anti-anxiety psychotropic medications include anticholinergic effects such as blurred vision, dry mouth, urinary retention - which can require catheterization in order to facilitate voiding, constipation, and sexual dysfunction.  An interpretation difficulty arises, then, when in double-blind, placebo controlled studies of efficacy subjects in the placebo group fail to experience any of these well-known side effects and as a result become less than blind to their experimental condition.  Similarly, those subjects in the control group become aware of their condition by experiencing side effects it then becomes difficult to extract true drug effect from expectancy effects.

Aside from the difficulties that side effects present in interpretation of research results, there are clinical concerns any time that such medications are used.  Anticholinergic effects may be especially significant in treating elderly patients who are at increased vulnerability to side effects such as bradycardia, gastrointestinal intolerance, weight loss, and increased confusion. However, these side effects are often “balanced” by potential for individual improvement in quality of life.  Other side effects include nausea, dizziness, headache, tension, sedation, weight gain,  postural hypotension, and more (PDR, 2004).

The anti-psychotic medications, also referred to as neuroleptics or major tranquilizers, may have serious, life threatening, side effects.  Anti-psychotics have calmed the positive symptoms of schizophrenia (delusions and hallucinations) but this calm may be synonymous with sedation.  Patients are often heavily sedated, chronically thirsty, dry mouthed, and motorically out of control.  Anticholinergic side effects may include disorientation, agitation, hallucinations, fever, seizures, stupor, and coma (PDR, 2004).

At times the anti-psychotics also induce side effects similar to anti-depressants and anti-anxiety medications such as blurred vision, constipation, and urinary retention.  The list goes on - incontinence of both bowel and bladder, drooling, orthostatic hypotension, gynecomastia (enlarged breasts – male and female), galactorrhea (lactation of the breasts – male and female), sexual dysfunction, significant weight gain, sedation, skin rashes and photosensitivity, epileptogeneic effects (seizures), cardiotoxicity, neuroleptic induced acute dystonia (abnormal movements reflecting slow sustained muscular contraction, may involve trunk, neck, jaw, mouth, eyes, and which can be painful), neuroleptic induced parkinsonism, masked facies, rigidity, bradykinesia, shuffling gait, stooped posture, also known as the “Haldol Shuffle”, neuroleptic induced acute akathisia (intense sensation of restlessness), neuroleptic induced tardive dyskinesia (abnormal, involuntary, irregular movements which may be irreversible), tremor, and neuroleptic malignant syndrome (severe muscle rigidity, elevated temperature, diaphoresis, dysphagia, incontinence, mutism, elevated or labile blood pressure, death) (PDR, 2004; American Psychiatric Association, 1994).  Taking into consideration that studies designed to generate percentage of prevalence for these side effects have proved non-generalizeable to the population makes determination of the rate of occurrences, as well as the degree of human debilitation impossible to quantify.  The potential for both good and ill effects of anti-psychotics exists, and their use and dis-use is understandable.

Factoring in that the prescribing of medication has shown significant growth (Balis et al. 1997; Sturm et al., 1995); medication compliance is often problematic for care providers.  Studies have noted that medication non-compliance is often related to poor treatment outcome and a common reason for non-compliance is reported to be the side effects (Schwenk, Evans, Laden, Lewis, 2004).

As medication compliance remains an obstacle marketing efforts of treatment facilities and pharmaceutical companies have attempted to address the problem.  In one brochure produced by St. Paul-Ramsey Medical Center titled A Way To Recovery, Use of Psychiatric Medications it is stated that “medications are needed to become well” and “medications are needed to stay well.”  There is no mention of potential harm or alternative treatment strategies.  Monmaney (1999) suggests the relaying of information to the public at large regarding potential dangerous effects of drugs is often delayed because when problems do emerge, the pharmaceutical companies and drug proponents initiate a vigorous strategy of defending the drug.

 One example of such delay involved risperidone also known as Risperdal.  On July 21, 2004 Janssen pharmaceutical company mailed out an important correction of drug information to all health care providers.  This correction pointed out that the Food and Drug administration’s Division of Drug, Marketing, Advertising, and Communications (DDMAC) had asked Janssen Pharamceutica Products to contact health care providers because of a “recently” received warning letter concerning the pharmaceutical company’s promotion of Risperdal.  The warning letter concluded that Janssen disseminated a Risperdal Dear Health Care Provider (DCHP) packet insert dated November 10, 2003 that omitted material information about Risperdal, minimizing potentially fatal risks, and made misleading claims suggesting superior safety to other atypical anti-psychotics without adequate substantiation, which was in violation of the Federal Food, Drug and Cosmetic Act (Mahmoud, 2004). Eight months passed before this information was communicated to care providers, over half of a fiscal year in sales.

  Although the Food & Drug Administration (FDA) is the primary entity empowered to police the dangerousness of medications being released to the public, only 4% of the FDA’s budget is allocated to monitoring side effects once drugs have been approved (Monmaney, 1999).  FDA Commissioner David Kessler revealed in 1993 that only about 1% of serious events [side effects] were reported to the FDA (Glenmullen, 2000).

An increasing concern is the treatment of childhood behaviors as biological “disorders” in need of medication (Fisher & Fisher, 1996).   Use of psychotropic medications with children has not been tested sufficiently to show they are safe or effective in children.  Many are prescribed “off-label” (not FDA approved).  Nor have there been longitudinal studies to determine any potential long-term consequences (Ramchandani, 2004; Fisher & Fisher, 1996). In 1997 over 2 million children were being treated with medication and the numbers are estimated to be even higher today despite a near-unanimous body of literature indicating that antidepressants are no more effective than placebos in treating depression in children and adolescents (Edwards, 2003; Fisher et al., 1996).

On December 10, 2003 Gordon Duff, chairman of the Committee on Safety of Medicines in the United Kingdom, advised that most of the antidepressant drugs in the selective serotonin reuptake inhibitor group should not be used to treat major depressive disorder in children and adolescents under the age of 18 years.  The new advice follows the review of data from clinical trials by an expert working group, convened initially because of concerns that selective serotonin reuptake inhibitors may increase the risk of suicidal thoughts and self harm in young people. The group concluded that the balance of risks and benefits was unfavorable for three of the selective serotonin reuptake inhibitors (sertraline [zoloft], citalopram [celexa], and escitalopram [lexapro]) and that there was insufficient evidence to support the use of a fourth, fluvoxamine [luvox] (Ramchandani, 2004).

The number of American children diagnosed and medicated for attention deficit hyperactivity disorder (ADHD) more than quadrupled in the 1990’s (Tanielian, Marcus, Suarez, & Pincus, 2001).  One might expect these numbers with a newly diagnosed disorder; however the disorder has been articulated for three decades.  Thirty years ago ADHD was diagnosed mostly in young boys who had attention problems such as difficulty staying in their seats or waiting their turn.  Now it has spread from boys to girls and to all age groups, including adults.  Although behavior modification, parenting education and focus training are effective treatment’s of ADHD behaviors, especially with early intervention, psychiatry continues to assert that medication yields the most success (Edwards, 2003; Handen, Feldman, Lurier, & Murray, 1999; Perring, 1997).

Moreover, some experts dispute the contention that ADHD should be termed a “disorder”.  Medical sociologist Peter Conrad of Brandeis University believes that the increased use of drugs is an example of how Americans have come to treat normal differences among children and adults as evidence of disease (Edwards, 2003).

In summary, biological causation is somewhat synonymous with the chemical imbalance hypothesis.  The essential postulate is that all behaviors are rooted in the quantity chemistry of neurotransmission (our biology).  It is thought you either have too much or not enough neurotransmitters and medication serves as a correction factor in the equation.  However, when taking into consideration questionable drug efficacy studies with a continued significant rise in the prescribing of psychotropic medications, it is of interest to explore if there are other variables influencing the theory of biological basis for behavior.  Read more commentary regarding several influences that are believed to contribute to the development of biological causation worldviews of many mental health professionals

Donna M. Midkiff, PsyD