Any doctor who pushes a drug for off-label non-approved use should be terminated. Preferably as quickly as possible.
Question 1: What is the Definition of OLDU?
The most common form of OLDU involves prescribing currently available and marketed medications but for an indication (eg, a disease or a symptom) that has never received Food and Drug Administration (FDA) approval.
8,9 Hence, the specific use is “off-label” (ie, not approved by the FDA and not listed in FDA-required drug-labeling information). The term
OLDU can also apply to the use of a marketed medication in a patient population (eg, pediatric), dosage, or dosage form that does not have FDA approval.
Question 2: Is OLDU Common?
Indeed, OLDU is common. Radley et al
1 reported in 2006 that in a group of commonly used medications, 21% of prescriptions were for an off-label use. In certain subpopulations of patients, this rate may be even higher. For example, a study by Shah et al
11 found that 78.9% of children discharged from pediatric hospitals were taking at least 1 off-label medication. In addition, in a pediatric emergency department, the rate of OLDU was estimated to be 26.2%.
2 The off-label use of antidepressant, anticonvulsant, and antipsychotic medications is high and is more prevalent with increasing patient age.
12 In an intensive care unit, Lat et al
13 reported that 36.2% of medication orders were for an off-label use. In addition, β-adrenergic blocking agents are commonly prescribed for an off-label indication, and specialists may more commonly prescribe for off-label β-blocker use than primary care physicians.
10 In a headache specialty practice, Loder and Biondi
14 reported that off-label use accounted for 47% of prescriptions written.
Question 3: Can an OLDU for a Given Drug Become a Widely Accepted Practice or Even a Standard of Care?
Off-label drug uses can become widely entrenched in clinical practice and become predominant treatments for a given clinical condition. For example, tricyclic antidepressants do not have FDA approval as a treatment for neuropathic pain, yet this class of drugs is considered a first-line treatment option.
15 The use of aspirin provides another interesting example of OLDU. Aspirin was widely used before the introduction of the Food, Drug, and Cosmetic Act of 1938. Therefore, aspirin was grandfathered and approved as an existing drug without the rigorous testing that modern medications undergo. Currently, aspirin is FDA approved for use in patients with pain, fever, rheumatic diseases, cardiovascular diseases (eg, acute myocardial infarction, previous myocardial infarction, angina pectoris, and previous cerebrovascular disease), and a history of a revascularization procedure (eg, coronary artery bypass grafting and carotid endarterectomy).
16 However, aspirin does not have an indication for coronary disease prophylaxis in diabetic patients, yet guidelines recommend its use in these patients.
8 Therefore, aspirin prophylaxis for coronary disease in high-risk patients is an off-label use.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3538391/