A significant minority of physicians incorrectly identified the use of certain drugs as having been approved by the U.S. Food and Drug Administration (FDA), according to a national survey that reiterates the importance of patients understanding "on-label" versus "off-label" drug use.
When the safety and effectiveness of a drug has been demonstrated in studies, pharmaceutical manufacturers seek FDA approval, which includes getting approval of a label that describes indications of use, dosage and method of administration. If the drug and its label are approved by the FDA, doctors may prescribe it to the general population.
- When the drug is prescribed for uses that are clearly listed on its label and have been approved by the FDA, such usages are described as "on-label."
- When the drug is prescribed for usage that is not described on its label and has not been approved by the FDA (which doctors may legally do for various reasons), its use is described as “off-label.”
Here’s a prime example in relation to patients dealing with back pain:
- While the brand name drug Neurontin (gabapentin) has been approved by the FDA for "on-label" use among adult patients with post-herpetic neuralgia, it is commonly prescribed “off-label” to patients who have been diagnosed with chronic back pain or chronic low back pain.
- In other words, while the Neurontin label does not indicate usage for back pain, it is still prescribed "off-label" for this condition.
With this understood, a University of Chicago-led survey of nearly 1200 physicians (specifically 599 primary care physicians and 600 physiatrists from around the country) revealed some confusion about the "on-label" and "off-label" usage of select drugs among 22 drug-indication pairs.
So What Did the Survey Reveal?
Physicians correctly identified the FDA-approved status of just slightly more than half (55%) of the drugs in the survey. Especially of interest, physicians who had previously prescribed drugs for "off-label" uses were more likely to respond incorrectly in the survey that such uses of the drug had been approved by the FDA.
Here are just a few drugs whose "on-label" usage created confusion in the survey:
- Lorazepam. This drug has not been approved to treat chronic anxiety, yet 26% of the surveyed physicians thought it had been approved for this purpose, with 33% of those incorrect physicians having previously prescribed the drug for this reason.
- Seroquel (quetiapine). This drug has not been approved by the FDA for treatment of dementia with agitation, yet 13% of the surveyed physicians thought that it has been approved for this purpose, with 19% of those misinformed physicians having previously prescribed Seroquel to treat such dementia.
Also of interest is the fact that some doctors were prescribing Seroquel for dementia at a time of the study (2007-2008) when the FDA had advised that quetiapine not be prescribed for dementia.
Patient Considerations with "Off-Label" Drug Usage
With these findings in mind, why should patients -- especially those with back pain, neck pain, and other pain related to the spine -- care?
Here are a few reasons:
- Doctors may prescribe drugs for "off-label" usages for many purposes that are quite relevant, specifically when back pain and/or neck pain has not responded to other approved treatments.
- As seen in both the Lorazepam and Seroquel examples, physicians are not always right when prescribing drugs as "on-label."
- As evident in the Seroquel example, doctors may unknowingly prescribe drugs for "off-label" purposes at times when the FDA has already advised against such actions.
- For any patient who is prescribed a drug, it is important to confirm if the specific usage is “on-label” or “off-label.” If the drug is being prescribed "off-label," it is particularly crucial to get an understanding of the risks and benefits of such usage.
- Patients should do their homework and check out recommended drugs and their approved indications and uses on reputable sites like the FDA, Medline Plus and the Pain Medications section of Spine-health, in addition to speaking with their doctor.
For more information, see the resources below.
Source: Therapeutics Daily
Update (September 2, 2009): In related news, the world's largest drug maker Pfizer has been penalized a staggering $2.3 billion as part of a record settlement for alleged violations of federal drug rules, including marketing painkiller Bextra and three other drugs for "off-label" purposes that were not approved by the FDA. According to the allegations, Pfizer personnel created false doctor requests for pain reliever Bextra, anti-psychotic Geodon, antibiotic Zyvox, and anti-epletic Lyrica in order to provide doctors with unsolicited information about unapproved uses of these drugs. While it is legal for doctors to prescribe medications for "off-label" purposes, drug manufacturers may not market those drugs for reasons not approved by the FDA, something that Pfizer would hopefully be aware of now. Source: Associated Press