Study Reveals that Patients Often Not Informed When Prescriptions Given for "Off-Label" Use
A recently released study found that doctors commonly prescribe medications for off-label use, but almost never inform their patients of that critical fact. This behavior runs directly counter to regulations issued by the U.S. Food and Drug Administration (FDA) and represents a possible danger to patients across Mississippi.
All drugs that reach the market have gone through clinical trials in order to determine their efficacy and safety for their intended purpose. Once the FDA feels the medication has met all of its requirements, it then approves the label for the medication. The drug is then meant to be used for its intended purpose which is specified on the label.
The term “off-label” means using a medication to treat a problem
that it was not originally intended for. It can also refer to the use
or form of a dosage of the drug that has not been approved by the FDA.
A 2006 study found that one in five prescriptions were for off-label use.
Off-label drug use is not without its risks. One of the purposes of the rigorous testing procedures that drug manufacturers must submit their products to is to determine safe dosages for drugs given the problems they are intended to treat. Doctors cannot rely on published studies as guidance for the proper dosage of a medication if it is being used for off-label purposes given that such studies concern the labeled use of the drug. As a result, a patient could receive a dose that’s too high or too low, which can end up causing more harm than good. There is also a higher risk of medication error, side effects and adverse reactions due to the lack of information in existence about many off-label uses.
While off-label drug use is not illegal in the United States, drug manufacturers are prohibited by law from promoting such uses. Even this rule is often flouted, so much so that a major drug manufacturer, GlaxoSmithKline, recently settled a $3 billion case with the FDA for encouraging doctors to use certain medications off-label.
Those who have suffered injuries at the hand of their doctor should be aware that legal remedies might be available to them. If you would like to speak with a Mississippi medical malpractice attorney about a potential medical malpractice claim, call Mississippi medical malpractice attorneys at Kobs & Philley today at (601) 863-8170.
Source: “Patients Often Kept in Dark About ‘Off-Label’ Drug Use: Study,” published at iVillage.com.
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