Treating Medical Conditions through Off-Label Use of Psychiatric Drugs

An off-label use of a drug is one that has not been FDA-approved, cannot be promoted by pharmaceutical companies, and may or may not be effective because there is no requirement for clinical studies that prove effectiveness. Doctors are legally allowed to prescribe medications for off-label use.

When looking at psychiatric drugs, the drugs used can be sorted into one of a few categories. Antidepressants, antipsychotics, mood stabilizers and or anticonvulsants, anti-anxiety, and "other" are recognized to be the main categories of psychiatric drugs. Through mandatory research and clinical trials, these medications carry only one or a few FDA-intended uses. The off-labeled uses can be proven safe and effective when independent research firms conduct research and clinical trials. Off-label uses can also be fabricated and have no published proof of successful treatment. The main thing to remember with off-label uses of psychiatric drugs, side effects are plentiful and can cause worse symptoms than the symptoms of the problem being treated.

There are a few classifications for the different types of antidepressant's. The class named SSRI's (selective serotonin reuptake inhibitors) have the most intended and off-label uses, so we'll focus on them. Prozac was the first SSRI that was FDA approved in 1987. Since then has been FDA approved for major depression in adults, panic disorders, obsessive-compulsive disorders, bulimia, and premenstrual dysphoric disorder. Some of its off-label uses are ADD/ADHD, bipolar disorder, headaches, lupus, premature ejaculation, and irritable bowel syndrome (IBS). As you can see and are probably questioning, this psychiatric medicine is used for non-psychiatric problems. Other off-label uses shared by other SSRI's include autism spectrum disorders, pathological gambling, Raynaud's phenomenon, arthritis, and fatigue disorders.

The antipsychotic medications of today, called atypical, have come a long way from their predecessors that caused tardive dyskinesia, a serious disorder that causes uncontrollable tics and can be irreversible. Zyprexa and Seroquel are the most common prescribed atypical antipsychotics and are FDA approved for schizophrenia and bipolar mania. Zyprexa's list of off-label uses is vast and includes borderline personality disorder, Tourette's disorder, self injury, anorexia (not the disorder, anorexia is simply having no appetite), managing cancer pain, autism, body dysmorphic disorder, and ten more problems. Seroquel's off-label uses are similar to Zyprexa, but include insomnia, managing symptoms of Parkinson's Disease, and Tourette's disorder in children. The atypical antipsychotic Risperdal was granted FDA approval for the treatment of Autism Spectrum Disorders, and remains the only one to have approval for that intended use. The most common, undesired side effect that almost always accompanies the atypical antipsychotics is weight gain, especially in Zyprexa. When choosing this path for treatment, it is mandatory to be informed by the doctor or through independent research, of all the potential side effects. Along with weight gain, some of these drugs can cause type II diabetes.

Lithium is the first and most common treatment for mania and managing bipolar disorder. An incredible amount of research has been done to find off-label uses for Lithium, but Grave's Disease (hyperthyroidism) and cluster headaches are the only tested uses. Lithium is technically an anti-manic agent, the rest of the medications are anticonvulsants originally developed for epilepsy. Depakote is the most prescribed anticonvulsant for bipolar disorder. Some proven off-label uses include alcohol and drug dependence, post traumatic stress disorder, restless leg syndrome, Alzheimer's disorder, and borderline personality disorder. Lamictal is very popular for treating bipolar disorder, but unless the patient is already stable when starting treatment, it is an off-label use. Schizoaffective disorder and diabetic neuropathy are other off-label uses. Finally, Topamax is the "new kid on the block", only indicated for seizures. But it surpasses the other anticonvulsants for off-label uses; bipolar disorder, eating disorders and vanity dieting, alcoholism, post traumatic disorder, sleep disorders, autism, and in one study, healing old external scars.

The two classes of anti-anxiety medication are barbiturates and benzodiazepines. Barbiturates are prescribed less often because of how powerful they can be. The most common benzodiazepines include Valium and Xanax. They are intended for panic disorders, but are prescribed equally, if not more often for insomnia and sleep problems. Valium is used off-label in surgery for its amnesia effects, and is used to treat painful muscle disorders, and Xanax is prescribed for IBS as an off-label use.

An off-use of many calcium channel blockers such as Verapimil, is for bipolar disorder mania. Stimulants used in treating ADHD (attention deficit hyperactive disorder) specifically amphetamines, are notorious for being prescribed for weight loss- an off-label use that finds doctors either supporting or refusing it, rarely a middle ground. The biggest wave of off-label use recently has been for treating depression. There is a huge amount of controversy surrounding this treatment, and rumors are swirling on the internet of the newest amphetamine ADHD medication seeking FDA approval for depression. The break-through Alzheimer's drug Aricept has been identified for ADHD and memory problems in traumatic brain injury as off-label uses.

A thorough explanation of the benefits and risks of any prescription should always be provided by the dispensing physician. Patients receiving psychiatric medication need to draw the line between manageable adverse effects, and effects that are worse than the symptoms being treated affecting the normal functions of everyday life. This disabling condition is the main reason of when a drug should be discontinued. Along with being informed about effects while taking a psychiatric drug, doctors need to inform their patients of the danger in suddenly discontinuing these drugs. The withdrawal effects of most psychiatric medicines can be uncomfortable, painful, and sometimes require hospitalization. When stopping psychiatric drugs, the doctor should create a schedule to taper the medicine slowly, eliminating most withdrawal effects. And the ultimate consequence of abruptly stopping psychiatric medications is a return of symptoms which can be worse than before.