Off-Label Prescription Dangers

In this blog, I’ve often discussed the common practice of doctors prescribing drugs for off-label uses. This is a perfectly acceptable practice since it’s generally assumed that doctors have the knowledge and expertise to make such a decision. In discussing this practice, I’ve distinguished this from the prohibited practice of pharmaceutical companies marketing their drugs for off-label uses. The FDA has maintained that drug companies may only advertise drugs for purposes specifically approved by the federal agency.
However, the NY Times is reporting that a national survey of physicians has found a disturbing trend in the off-label use practice. The study in Pharmacoepidemiology and Drug Safety found that many doctors aren’t aware when they are prescribing drugs for off-label use. According to the study, the average physician’s survey response indicated that they identified the F.D.A. approval status correctly for only about half the drugs on a list provided by the researchers.
The gastrointestinal drug Reglan (generic equivalent Metoclopramide) has been approved for 90 day use by the FDA. Yet, Reglan continues to be prescribed for longer periods than the approved 90 days. Longer term usage has been linked with a serious central nervous system disorder called Tardive Dyskinesia.
Ignorance of a drug’s FDA approval status can be dangerous and cause significant damage to the patient. For instance, the survey found the most physician confusion concerning psychiatric drugs. According to the NY Times article, “Confusion was greatest with psychiatric drugs, the survey of some 600 doctors found. Nearly one in five who prescribed Seroquel (quetiapine) in the previous year thought it was approved for patients with dementia and agitation, even though it was never approved for this use and even carried a “black box” warning that it was dangerous for elderly patients with dementia. And one in three doctors who used lorazepam (often marketed as Ativan) to treat chronic anxiety thought it had been approved for this use; in fact, the F.D.A. warning advises against using it for this purpose.”