In many cases doctors prescribe antibiotics “off-label”, for indications that have not been approved by the FDA, or established as safe and effective. However, new research suggests that the decision to provide these medications for non-approved users are often not based on sound science.
In a study published last week in the medical journal The BMJ, Canadian researchers indicate that only about 16% of “off-label” prescriptions for antidepressant drugs are supported by strong evidence, yet often there is another medication in the same class of drugs that has scientific support for the indication.
Off-label is a term used to describe when a drug is prescribed for uses not approved by the FDA. While drug makers are only able to promote medications for indications that are FDA approved, doctors are able to prescribe any medication on the market for any purpose they see fit.
In this latest study, researchers used data on 106,850 antidepressant prescriptions given out by 174 physicians, involving 20,920 adults. They looked at data on patients 18 and older who received these prescriptions between January 2003 and September 2015. Data was taken from an indication-based electronic prescribing system.
According to their findings. trycyclic antidepressants were the most common antidepressants prescribed off-label, mainly due to the high off-label prescribing rate for amitriptyline, which is prescribed off-label 93% of the time, the researchers found. However, the most common off-label prescription for antidepressants involved the drug Oleptro (trazodone), which is often prescribed for insomnia.
Researchers indicate that only 15.9% of all off-label antidepressant prescriptions were backed by strong scientific evidence that the drug was appropriate for that use.
“When primary care physicians prescribed antidepressants for off-label indications, these indications were usually not supported by strong scientific evidence, yet often another antidepressant in the same class existed that had strong evidence for the respective indication,” the researchers found. “There is an important need to generate and provide physicians with evidence on off-label antidepressant use to optimise prescribing decisions.”
Many popular antidepressants have been linked to a risk of serious health risks, especially when given to pregnant women, highlighting the concerns surrounding unnecessary prescriptions. For children exposed to the medication before birth, antidepressant side effects may include septal heart defects, skull malformations, neural tube defects, abdominal defects, spina bifida and other serious injuries.
Recent studies have also found that antidepressant use in pregnancy may increase the risk of seizure problems and delay of infant development milestones, such as sitting and walking are affected by antidepressant use during pregnancy.
Pregnancy antidepressant risks have also been linked to a serious respiratory disorder, known as persistent pulmonary hypertension in newborns (PPHN), which may cause insufficient blood flow to the lungs, leading to serious and potentially life-threatening problems.
In recent years, a growing number of Zoloft lawsuits and Paxil lawsuits have been filed in courts throughout the United States on behalf of children born with defects and malformations after exposure to the medication during pregnancy. The complaints allege that the manufacturers of the medications failed to adequately research the risks associated with use of the antidepressant in pregnancy, or provide proper warnings to women about the risk of becoming pregnant while using the medication.