By Richard Ueberfluss

There is a new study out that suggests that 12 percent of drugs doctors prescribe are for uses other than those approved by regulators.  These are known as “off-label” since they are not prescribed for certain conditions for which they are being prescribed.

While this doesn’t always mean a negative outcome, patients should be encouraged to ask their doctor if the drug they are getting is for an approved use, since they sometimes have negative side effects.

To get a better understanding of off-label, the drug label of FDA-approved drugs gives information about the drug, including the approved doses and how it’s to be given to treat the medical condition for which it was approved. When a drug is used in a way that is different from that described in the FDA-approved drug label, it is said to be an “off-label” use. This can mean that the drug is:

• Used for a different disease or medical condition.
• Given in a different way (such as by a different route).
• Given in a different dose.

For example, when a chemotherapy drug is approved for treating one type of cancer, but is used to treat a different cancer, it is off-label use.

Off-label is also called “non-approved” or “unapproved” use of a drug. New uses for these drugs may have been found, and often medical evidence supports the new use. But the makers of the drugs have not put them through the formal, lengthy, and often costly studies required by FDA to officially approve the drug for new uses.

It’s not a surprise that the Food & Drug Administration is studying this issue and offers the following recommendations:

If you and your Healthcare Provider are considering off-label use of an approved drug, consider asking these questions before deciding whether it is right for you.

• Is there information available to support the off-label use of this drug to treat my condition?
• Is this off-label drug likely to work better than an approved drug?
• What are the risks and benefits of off-label treatment with this drug?
• Will my health insurance cover off-label treatment with this drug?

One of the findings of the aforementioned study according to the Wall Street Journal is that “doctors often don’t know if the reason for the prescribing of a drug is off-label. They typically choose a drug based on other patients’ experiences with similar conditions or clinical guidelines from professional organizations.”

Some examples of off-label use include:

• Quinine, which is approved for malaria, but is often prescribed for nocturnal leg pain.
• Quetipine, which is approved for bipolar disorder, is often prescribed for dementia insomnia.

Does this pose a danger?  Not usually, and in many cases, it works to alleviate many conditions.

It’s probably a good idea to have discussion with your health care provider concerning your current medications and any new medications that may be prescribed.