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Is prescribing a drug off-label a form of medical malpractice?

On Behalf of | Jun 8, 2022 | Medical Malpractice |

Medication manufacturers have to thoroughly test the drugs they produce before releasing them to the public. The Food and Drug Administration (FDA) scrutinizes claims about the safety and efficacy of a medication.

The manufacturer will need to fund research that demonstrates that the drug does not cause any serious harm to people and that it achieved the intended therapeutic effect in a significant number of the people treated during the study.

Once the FDA trusts the evidence provided by the manufacturer, they can release the FDA-approved medication for specific medical uses. If a doctor prescribes you a drug for a purpose other than the one the FDA approved, is their decision a kind of medical malpractice?

Off-label drug use is a gray area in medicine

In theory, drugs approved by the FDA are safe for people to take. However, it may not be as safe for some people as for others, and the medication may not be as effective when used for an off-label purpose as opposed to an approved one.

Simply prescribing an FDA-approved medication for a purpose other than its approved use is not inherently malpractice. However, a doctor may need to justify their decision by showing evidence that supports their intended use of the medication. They also need to ensure the patient understands the risks involved.

Records showing that the doctor warned the patient about possible side effects can also come into play in medical malpractice claims relating to the inappropriate administration of a drug. Holding a doctor accountable when they do not meet professional standards may require a medical malpractice insurance claim or possibly a lawsuit.