Do You Get ‘Off-Label’ Drugs?

Many people with health problems that defy the usual treatments their doctor has given them end up taking a prescription drug ‘off-label’. This means that the doctor is prescribing it for a use that has not been approved by the USA Federal Drug Agency.

When a pharmaceutical company applies for permission to market a new drug they have to provide evidence from ‘well-conducted clinical trials’ that show it’s effective and safe in a specific medical indication. And to be able to market it for additional indications, they have to do trials in each indication. Sometimes the company will not undertake the work needed to prove effectiveness in additional indications, even though it’s likely the drug will be valuable in another disease. Then some physicians may be tempted to prescribe the drug ‘off-label’.

In fact, over 100 million off-label prescriptions are written each year in the USA.

The problem is that about three-quarters of these are written for indications that have “little or no scientific support”, according to a report in the Archives of Internal Medicine. The sort of drugs that are most prescribed off-label are cardiac drugs, anticonvulsants, antiasthmatics, antiallergy, and psychiatric drugs.

It must be admitted that many of the indications for which off-label use is prescribed are logical extensions of FDA-approved indications. An example would be the use of an antiasthmatic drug for chronic obstructive pulmonary disease (COPD). But, the evidence from well-conducted trials is lacking.

So, next time your doctor says “I’m going to try this drug on you – I’ve used it a lot for treating XYZ disease, and it may help your problem” be a little suspicious. Perhaps you are about to participate in a clinical trial of one patient.