Off Label Drug Use

Once a drug is approved, it can be prescribed by physicians for any reason.  Those reasons can include conditions that were not studied by the manufacturer in the clinical trials.  And, those off-label uses are not things that can be marketed to the physican.

Some of this is controlled by prior authorizations (PAs) which require a physician to call into the managed care company or the pharmacy benefit management (PBM) company to justify the use of the medication.  This is often used on high cost medications with a high percentage of off-label prescribing.

For example, it is estimated that 76% of the prescriptions writen for Seroquel are for off-lable purposes.  (See article on this and other information here.)  This article also lays out the top drugs that are used off-label.

• Bupropion (Wellbutrin) approved for depression, commonly used off-label for bipolar diaorder.
• Sertraline (Zoloft) approved for depression, commonly used off-label for bipolar disorder.
• Venlafaxine (Effexor) approved for depression, commonly used off-label for bipolar disorder.
• Celecoxib (Celebrex) approved for joint sprain/strain, used off-label for fibromatosis — soft tissue tumors.
• Lisinopril (Prinivil, Zestril) approved to treat high blood pressure, used off-label for coronary artery disease.
• Duloxetine (Cymbalta) approved to treat depression, used off-label for anxiety.
• Trazodone (Desyrel) approved to treat depression, used off-label for sleep disturbance.
• Olanzapine (Zyprexa) approved to treat schizophrenia, used off-label for depression.
• Epoetin alfa (Procrit, Epogen) approved to treat chronic renal failure, used off-label for anemia from chronic disease.