Fighting For Justice And Your Best Interests

Is a doctor irresponsible for suggesting off-label medication use?

On Behalf of | Mar 16, 2023 | Emergency Rooms And Medication Errors |

There are hundreds of medications on the market, ranging from prescription sleep aids to weight loss drugs. Each of those medications has a unique formulation and a host of potential side effects. The companies that develop these medications generally have to conduct rigorous testing and then submit documentation to the Food and Drug Administration (FDA) for approval. Oftentimes, the FDA will approve the use of a drug for a specific medical issue despite it potentially having numerous other uses for which it has not been explicitly approved.

Doctors who are aware of those additional uses may recommend that someone use a medication off-label or for an unapproved purpose. Does an off-label drug recommendation constitute medical malpractice?

Some off-label prescribing is reasonable

There are certain scenarios in which it is reasonable and even quite intelligent of a doctor to prescribe the off-label use of a medication to a patient. It could be a lower-harm option than the current medications approved for that specific condition or symptom.

As a basic rule, any medication approved by the FDA is likely generally safe when used as recommended by a healthy adult. Therefore, doctors can prescribe that drug to people even for other purposes than the approved one without necessarily deviating from best medical practices.

However, if they prescribe the medication to someone with a contraindication or for a use that has a known history of poor outcomes, then that may constitute malpractice. For example, if a physician uses a drug in a way that directly contradicts safety warnings printed on the packaging by the FDA, then their choice might open them up to liability should the outcome of the situation prove unfavorable.

A second opinion is a good starting point

Typically, there needs to be a combination of a medical mistake and verifiable harm to a patient for someone to take action via a malpractice claim. For those who believe a physician may have made a major error that constitutes medical malpractice, the advice of another physician is often crucial to developing a case.

Another medical professional can let a patient know whether a doctor’s decision was merely questionable or was an obvious violation of current standards for the profession. Recognizing scenarios that may constitute medical malpractice can benefit those who are interested in seeking justice after an unfavorable medical outcome. As instances of medical malpractice can be difficult to spot with confidence, seeking legal guidance is usually a patient’s best “first step” in the process of protecting their rights.