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Off Label Prescriptions: Is Your Medication FDA-Approved For Your Specific Condition?

By Pamela Jean     Jun 7, 2007 in Health
Off-label prescribing, which is the practice of prescribing a drug outside of the scope of the drugs approved label is rampant. It is estimated that over 60% of all prescriptions written in the US are off-label. What does this mean for you, the consumer?
Are we all just guineau pigs, being used unwittingly each time we are given an "off label" prescription to treat an illness we are suffering from?
A study, released in May of 2006, indicates that 1 of every 5 prescriptions written in the US are "off-label" ,meaning the drug being used for treatment has not been approved for use as such by the FDA.
“Once the Food and Drug Administration (FDA) approves a new prescription drug for one medical indication, physicians are free to prescribe it for virtually any condition.
Experts agree that this practice is risky. Since nearly 3/4 of these off-label uses lack any long term study whatsoever.
"The FDA approves for specific indications. It doesn't vouch for the safety and efficacy of all uses," added Dr. Randall Stafford, senior author of the study and associate professor of medicine at the Stanford Prevention Research Center."
With the history in recent years of drugs being approved by the FDA and then found, after use by the general public, to be unsafe, it is any wonder why there may be potential problems with the obviously rampant practice of "off label" prescriptions?
Though it is not illegal, is it ethical?
If no scientific data exists as to the potential side effects of a drug being used for purposes other than those approved by the FDA, how does a physician safely take this route, without the risk of suffering legal ramifications?
Apparently the law makes it clear that in prescribing off-label, the physician is not in violation as far as the FDA is concerned.
In the world of law, where matters are rarely clear-cut, there are a few certainties about off-label use. First, it does not violate FDA law. The agency itself acknowledges this, its Center for Drug Evaluation and Research, stating, for example: "Neither the FDA nor the Federal government regulate the practice of medicine. Any approved product may be used by a licensed practitioner for uses other than those stated in the product label.
As a patient, are you required to be informed when your doctor is prescribing a medication that is off-label? Apparently the answer to that question is a definitive "no". From a legal standpoint, the determining factor is whether that information is considered material to the treatment. Different states have adopted different standards for determining whether information is material. The prevailing standard is whether a reasonable physician would provide the information, with the jury (or judge, if the case is being heard without a jury) required to decide the matter based on conflicting testimony by the parties' medical experts. An increasing number of states have adopted a "reasonable patient" standard, where the test is whether the jury (or judge) conclude, without the benefit of expert testimony (since there is no such thing as "an expert reasonable patient"), that a reasonable patient would have regarded the information as important.
So, essentially this information is generally not shared by physicians, and according to the legalaize stated above, is not required.
Off-label prescriptions are most prevalent among children. Given the fact that most drug studies are conducted only on adults, doctors lament that there are far fewer pharmaceutical options available to them when it comes to pediatric cases. Off-label prescribing is also common practice in cancer patients. As doctors consider the cancer patient's prognosis to be less than positive, they feel the benefits outway the risks.
Defender's of off-label prescribing call it "innovative medicine" and make mention of the fact that pharmaceutical companies are interested in profits, thus making the practice necessary. Off-label drugs are often prescribed successfully for diseases and illnesses that are far too uncommon for big pharma to invest the time, effort and big money in studying, and subsequently manufacturing. Where is the profit in a drug designed to specifically treat such a tiny portion of the population? There is none, and so those drugs aren't created. Thus calling on physicians to determine what other medications in existence may potentially treat these rare and ignored conditions.
The FDA forbids drug manufacturers to tout off-label uses, but industry watchers say the practice has been rampant among some companies.
The most extreme recent example was the illegal promotion of the epilepsy drug Neurontin for a host of other conditions, including migraine headaches, attention deficit disorder, drug and alcohol withdrawal, and bipolar disorder. Federal prosecutors accused the manufacturer, a unit of Pfizer Inc., of pushing these uses by misleading some doctors and paying others. In May 2004, the Pfizer unit pleaded guilty to two felonies and agreed to pay $430 million to settle the charges.
So, as consumers, what are we to do? I think it is obvious. We must take charge of our own health. Ask questions. When your doctor gives you a prescription, inquire as to how long the drug has been on the market, as well as whether it has been approved specifically for treatment of the condition you are suffering from. Do your own research. Thousands of sites are available on the internet, loaded with information regarding the drug you are being prescribed. Read them, read the inserts that accompany your prescription. Pay attention. You only get one shot at this life, and basically, you are the only person in charge of your own well being.
More about Off label, Prescriptions, Drug use