A recent study published in JAMA demonstrated that 45 percent of antidepressant medications are actually prescribed for conditions other than depression. In other words, almost half of antidepressants in this Canadian retrospective study were used for off-label drug use (OLDU), meaning these medications are not approved by the FDA for these specific indications.
Common classes of antidepressants like selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs) and tricyclic antidepressants (TCA) are approved by the FDA to treat depression. However many physicians prescribe these medications to treat and prevent many other disorders such as migraine headaches, chronic pain, neuropathy and sleep disorders. Although these problems may sound severe, off-label drug use can have some very dangerous consequences.
The problem with off-label drug use
An article published by Mayo Clinic explains the in-depth reasoning behind “off-label” medications. In order for the FDA to approve a specific medication, a drug must undergo extensive research in three main stages of clinical trials. Many patients cannot undergo clinical trials, and therefore treatment for certain patient populations are generally not FDA approved. Two very common patient populations that are not involved in clinical trials are the pediatric and pregnant populations. In fact, approximately 40 percent of children discharged from the hospital are prescribed at least one off- label medication and about 20 percent of children admitted to the ICU are given an off-label medication. Additionally, 20 percent of all medications prescribed for migraines are considered off label, including TCAs, a common class of antidepressants. It is difficult to enroll pregnant women, pediatric patients and terminally ill patients in clinical trials as it is considered unethical by most since there could be lethal side effects in experimental clinical trials.
In contrast, just because a medication is off label does not mean it is bad, broken or dangerous. In fact many off-label medications are considered first-line medications in standard clinical practice.
Common off-label uses for medications
It was found that the nonsteroidal anti-inflammatory agent indomethacin was effective in treating persistent, symptomatic patent ductus arteriosus in newborns which allowed a trial of indomethacin to become the treatment for this condition in order to avoid curative surgery. Despite this, indomethacin has not approved for such a use which means this administration remains an OLDU. “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). However, aspirin does not have an indication for coronary disease prophylaxis in diabetic patients, yet guidelines recommend its use in these patients. Therefore, aspirin prophylaxis for coronary disease in high-risk patients is an off-label use”, according to the study.
Anti-depressants have been clinically proven to treat and alleviate migraines and chronic pain and although they may not be approved by the FDA for these specific indications, they are much safer and tolerable than opioids which are becoming a top killer in the United States due to their rampant addictive properties.
A note of caution
Of course, it is important to ensure that off-label medications are backed up by evidence-based literature. Many physicians learn the off-label use of very old medication while in medical school however when newer conditions such as fibromyalgia emerge, off-label drugs do reappear in new literature such as well-known journals pertaining to the specific medical specialty. If there is no known literature on an off-label medication, then it may be wise to reconsult with your physician regarding this specific drug.
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About the author
Kristen Fuller, M.D., is a senior staff writer at Sovereign Health and enjoys writing about evidence-based topic in the cutting world of medicine. She is a physician author who also teaches, practices medicine in the urgent care setting and contributes to medicine board education. She is an outdoor wildlife and dog enthusiast. For more information and other inquiries about this article, contact the author at firstname.lastname@example.org.