The Use of Off-Label Prescriptions Often Lacking in Scientific Evidence

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May 23, 2006 | 6,960 views

The U.S. FDA approves drugs for specific purposes. However, once a drug is approved, doctors can prescribe it for any use. According to a new study, more than one out of every seven drug prescriptions are for off-label uses that have no scientific support backing them.

In 2001, there were roughly 150 million prescriptions for off-label drug uses, about 21 percent of the total prescriptions given. However, almost three-quarters of those off-label prescriptions were for purposes that had no studies or scientific backing validating the use.

Off-label prescription was most common for heart drugs and anti-seizure medication.

It's bad enough that children and infants are overprescribed medications specifically meant for them; now the media is exposing the fact that kids are also being given drugs that have never been tested on children, with unknown effects.

I recently ran an article about the horrifying use of off-label antipsychotic drugs prescribed for kids, with disastrous results. This new study from the Archives of Internal Medicine indicated that the problem with off-label drugs is far more widespread.

In our "Have a problem? Take a pill!" society, drugs are already vastly overprescribed. This is a particular problem for children.

In the first year or two of life, your child's immune system is still being formed, and their experiences during this time can often predict whether or not they will have life-long health problems.

Some of the drugs most widely used for off-label purposes were:

This kind of prescription can be literally deadly. Elderly dementia patients who are prescribed Risperdal for off-label uses, which happens often, increase their chances of death by 54 percent within the 12 weeks of first taking it!

One researcher who worked on the study hit the problem right on the head, suggesting patients should ask more questions about the drugs their physicians prescribe, rather than assume FDA approval ensures safety, which we've seen time and again isn't the case.

Under the current system, once a drug is approved for any purpose, all off-label uses and abuses are allowed by the FDA.

There is no safety net for off-label uses. No need for safety studies, no need for effectiveness studies, no need for any research whatsoever. Once a drug company gets a drug approved, it can be sold as a cure for anything they can dream up.

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