The Food and Drug Administration (FDA) approves medications for specific uses which are posted on the labels. Less known, however, is the fact that the FDA does not regulate “off-label” prescribing. This term refers to a common practice when physicians prescribe a drug for something other than its intended use.
In many cases, off-label prescriptions can be valuable to patient recovery. Still, patients need to make sure they are fully aware of every detail about the prescriptions they are about to take.
Reasons Why Physicians Prescribe Medications for Off-Label Purposes
Particularly in the case of minor medical conditions, off-label use of prescription drugs can be very effective. For example, a person with a minor external skin irritation may benefit by applying a sore throat medication containing Lidocaine. Even for more serious conditions, however, doctors may prescribe medications off-label in situations such as the following:
In Some Cases, Off-Label Use of Drugs Has Devastating Effects
Sometimes, prescriptions may not be effective for off-label uses. In these cases, patients can suffer longer than necessary. Delayed treatment can also worsen some medical conditions. There are also times when off-label medication use can be the cause of serious new conditions.
Perhaps one of the most well-known examples of the risk of off-label prescriptions involved Fen-Phen. A WebMD article, Off-Label Drug Use: What You Need to Know, explains that the FDA approved two separate drugs, Fenfluramine hydrochloride and Phentermine hydrochloride as short-term treatments for obesity. After learning that the two drugs, when taken together, offer more dramatic weight loss effects, doctors started prescribing both drugs together for their patients.
The combination drug, known as Fen-Phen, caused severe injury to the heart valves of many individuals. After a multi-billion dollar lawsuit, the FDA removed Fen-Phen from the market in 1997.
Patients Should Make Sure to Read Labels and Ask Questions
Before taking prescriptions or over-the counter medications, patients should make it a habit to review all informational inserts and labels before taking the first dose. Keep in mind that even commonly-used medications can change, so every new purchase requires a label review.
When it is clear that a doctor has prescribed a medication for an off-label purpose, patients need to call back and discuss the reasons, the expected results and the potential side effects. Of course, those who sustain injuries or whose conditions worsen should speak with Tuscaloosa injury attorneys to learn about their legal options.
CareFusion to Pay the Government $40.1 Million to Resolve Allegations That Include More Than $11 Million in Kickbacks to One Doctor, United States Department of Justice, January 9, 2014
Ameridose Targeted in Bad Drug Probe – Alabama Clinics Notified, Tuscaloosa Medical Malpractice Blogs