Off-Label Use of Antipsychotics Alarms Experts

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Turn on the TV for two or three hours and you’re likely to see a commercial for Abilify – one of the newer antipsychotic medications being used to treat a variety of symptoms and disorders.  It’s advertised as an adjunct medication for those taking antidepressants for depression who aren’t quite experiencing the benefits they’d hoped for.

Antipsychotics, as the name suggests, were primarily developed to treat symptoms of psychosis.  For years, they were used almost exclusively for the treatment of the two most common psychotic disorders – schizophrenia and schizoaffective disorder.  The two most common psychotic symptoms are hallucinations – e.g. hearing voices – and delusions – e.g. the bizarre belief that aliens are controlling your mind via an implanted microchip.  For many individuals suffering from psychosis, these medications have been life-changing. Schizophrenia is one of the most debilitating and serious psychiatric disorders known to humankind.  These drugs – which were first used in the 1950s – radically changed its treatment in a very positive way (in most cases).

As time went on, scientists and physicians found that these powerful medications could also be beneficial for other symptoms and disorders.  Today, they are often used in the treatment of bipolar I disorder – particularly mania but also bipolar depression – as well as several other disorders that will be discussed later.

Because of their highly sedating effect, antipsychotics are often referred to as “major tranquilizers.”  They are also known as “neuroleptics,” due to the way they work in the brain.  They are also split into two categories, based primarily on when they were developed – first generation and second generation.

“First Generation” Antipsychotics

Antipsychotic medications in this early group were the first ones used to treat schizophrenia.  They are sometimes referred to as “typical” or “conventional” antipsychotics.  These early drugs are still very effective.  Unfortunately, though, their benefits often come at a high price in the form of serious – and sometimes permanent – side effects.   In many cases, however, the life-altering benefits seem to significantly outweigh any risks.

Medications in this early group include:

  • Compazine (prochlorperazine)
  • Haldol (haloperidol)
  • Loxitane (loxapine)
  • Mellaril (thioridazine)
  • Moban (molindone)
  • Navane (thiothixene)
  • Orap (pimozide)
  • Prolixin (fluphenazine)
  • Stelazine (trifluoperazine)
  • Thorazine (chlorpromazine)
  • Trilafon (perphenazine)

“Second Generation” Antipsychotics

After nearly four decades of reliance on first-generation antipsychotics, the second generation or “atypical” drugs began to appear on the market.  These drugs became quickly popular, largely because they were thought to have less intense and fewer side effects than conventional antipsychotics.

Medications in the “atypical” group include:

  • Abilify (aripiprazole) (aka the first “third generation” antipsychotic, but generally included with other second generation drugs)
  • Clozaril / FazaClo (clozapine)
  • Fanapt (iloperidone)
  • Geodon (ziprasidone)
  • Invega (paliperidone)
  • Risperdal (risperidone)
  • Saphris (asenapine)
  • Seroquel (quetiapine)
  • Symbyax (olanzapine and fluoxetine)
  • Zyprexa (olanzapine)

Not everyone agrees as to whether the newer antipsychotics provide any significant benefits over the earlier ones. Research has shown that some of the earlier medications are no less effective than the more recent ones.  This is important to consumers because the first-generation drugs (those that are still available today) are significantly less expensive than the newer ones.


Although antipsychotics were originally indicated for the treatment of psychotic disorders, especially schizophrenia, they’re use is much more far-reaching today than 20 or 30 years ago.  In fact, some experts are alarmed at how widely and easily these potentially dangerous medications are prescribed– especially when they are prescribed to children for “off-label” use.  (Off-label use of a drug means that the FDA has not officially approved it for the disorder or symptoms for which it is being prescribed. It’s a common practice, but one that has raised a growing number of concerns in recent years.)

Besides being used in the treatment of schizophrenia, schizoaffective disorder, and other psychotic disorders, antipsychotics are frequently used to treat:

  • Bipolar I disorder (including both depression and manic symptoms)
  • Tourette’s syndrome (which involves the presence of troubling and involuntary tics)
  • Major depression with psychotic features
  • Autism-related irritability in children
  • Agitation (Haldol is a popular drug of choice to calm agitated patients in hospital ERs and inpatient units.)
  • Severe nausea and vomiting

A frequent and alarming off-label use includes treating kids who struggle with ADHD or conduct disorder.  This practice has raised some serious eyebrows, as doctors are prescribing antipsychotics off-label for youngsters as young as 3.

Impact on the Brain

Like almost every other psychiatric medication available today, these powerful medications target specific neurotransmitters – chemicals such as serotonin and dopamine  – in the brain.  These chemicals are believed to be associated with mood symptoms as well as psychosis.

Side Effects     

 One of the primary reasons there is a lot of controversy around the use of antipsychotic drugs, especially for off-label use for so many disorders and in vulnerable individuals (such as young children), is the very serious potential side effects for which these drugs are notorious.

All medications come with an array of potential side effects – many of which are listed only because they occurred in a very tiny percentage of those who participated in early clinical trials.  But the serious side effects associated with antipsychotics are not highly unlikely or extremely rare.  This isn’t to say that these medications don’t have their place in the treatment of psychiatric disorders, but they should always be used with extreme caution – especially when prescribed for children, adolescents, or elderly individuals.

Some of the most serious side effects include:

  • Tardive dyskinesia (a challenging movement disorder that can become permanent in some cases, particularly with long-term use)
  • Neuroleptic malignant syndrome – which is potentially fatal
  • Diabetes
  • Elevated cholesterol
  • Severe weight gain

Some side effects occur more frequently in the typical antipsychotics, while others tend to be more often associated with the atypical drugs.

A few, other less severe antipsychotic side effects include:

  • Dry mouth
  • Sexual dysfunction
  • Seizures
  • Restless leg syndrome
  • Sedation
  • Muscle spasms
  • Nausea and vomiting
  • Blurry vision
  • Sleep disturbances
  • Constipation
  • Headaches
  • Changes in behavior
  • Tiredness
  • Dizziness

Use Caution

Medication should always be used cautiously, and only if truly necessary.  This is particularly true when it comes to antipsychotics.  It’s vitally important that you inform your physician of the following:

  • Past or present medical conditions
  • If you’re pregnant, planning to get pregnant, or nursing
  • Any alcohol or drug use, including any history of addiction or abuse
  • Drug allergies
  • Other medications you’re currently taking, including supplements, herbal remedies, and OTC medications

Once you start taking an antipsychotic medication (and any medication for that matter), be sure to take it exactly as your doctor prescribed.  Just because one is good doesn’t mean two is better.  Playing around with the dose or skipping your meds from time to time can lead to serious problems.  Be sure to inform your doctor of any side effects, and never stop your medication without talking to your doctor first.

Antipsychotic medications have literally changed millions of lives over the past 60 years, particularly for those struggling with severe mental illnesses like schizophrenia or bipolar disorder.  But that doesn’t mean they’re right for everyone.  They don’t always work for everyone who takes them – no medication works 100% of the time for 100% of those taking it.  Because of the potential for serious side effects, always carefully weigh the pros and cons.  Do your research and make an informed decision.

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