Tag: Off-label prescribing

The main problem with prescribing psychiatric drugs to children is that it hasn’t been very effective.

Researchers point to the risks of using antipsychotics with youth and caution against the practice.

Four years ago I dove into a deep and murky pond: the bottomless depths of medical databases that hold mental health research. After examining over 4000 studies, and hundreds of meta-analyses, I surfaced from my research and was hit with a startling “Aha” moment: non-drug approaches really work.

Over the past twenty years, the number of prescriptions for atypical antipsychotics written to children and young adults between four and eighteen has increased...

New data reveals that the majority of care homes in British Columbia, Canada are giving out prescriptions for antidepressants and antipsychotics without a diagnosis....

When I was born, everyone was expecting me to have arms. The doctor's mind raced; how am I going to tell this mother and the father that their son has hands but not arms? If he's missing so much in his extremities, mustn’t he also be missing a mind? My mom looked into my eyes and knew - in a way that only mothers know - that I had a mind, and spirit.

On Tuesday, the FDA entered into a settlement agreement in Amarin Pharma v. U.S. Food & Drug Administration, allowing Amarin to promote a prescription drug for off-label use, so long as its promotion is truthful and non-misleading. The Amarin Settlement seems to be an abandonment by the federal government of protecting the public from off-label prescriptions.  But these settlement were just the cost of doing business for the drug companies, while they continue rake in huge profits from the continued off-label prescribing of drugs, which does not diminish after the settlements. Of course, anything that is false or misleading is still grounds for charges, but that is a far harder case to make. I think the ban against off-label promotion is dead for all practical purposes.  

Medscape Psychiatry reports that the “man-made epidemic” of opioid abuse in the United States is the result of over-prescription and poor research.

Since the mid-1990s antipsychotic medications have been increasingly prescribed for children, adolescents, and adults. The most recent report finds an increase in use for older children from 2006 to 2008. Most of the prescriptions of antipsychotics for children reported by the study were for conditions which had not been approved by the FDA (called off-label use).

The US Food and Drug Administration has announced that there will soon be a public meeting to explore providing drug companies with greater flexibility in promoting off-label indications to doctors. When it comes to prescribing medications to children, and particularly psychiatric medications, this is a bad idea. I write both as a former consultant to the pharmaceutical industry, and as a father who lost a son to the toxic effects of antipsychotics prescribed off-label.