What is off-label drug use?

Off-label or “not approved” drug use means using medicine for an unapproved disease or medical condition. It also means your doctor may use the drug in an unapproved age group, dosage, or route of administration. Depending on your problem, a medical practitioner may decide to use prescription or non-prescription medications for off-label use. The following terms can mean off-label use of the drug:

What are some examples of off-label drug use?

  • Your physician may give a different dose of the drug than the approved dose. For instance, the dose of the medicine is approved at one capsule a day, but your doctor prescribes it twice a day.
  • Your physician may use it to treat a different medical condition or disease. For example, a drug is approved for a particular type of cancer, but your doctor may use it to treat a different kind of cancer
  • Your physician may use a different form of the drug. The drug may be approved as a capsule; however, it may be given in a solution form. 

What is on-label drug use?

The label (on-label) or “approved use” of the drug would be defined as using medication by a doctor precisely as approved by the FDA. When a physician deviates from that path, it is known as off-label use.

Why doctors prescribe drugs for label use?

When the drug is prescribed for its approved cause following points are assured:

  • FDA has conducted a careful evaluation of its risks and benefits
  • The use of the drug is backed by strong scientific data
  • Approved drug labeling for healthcare providers is available for the drug on how to use the drug safely and effectively  
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The approved drug labeling for healthcare providers provides vital information on the drug such as:

  • Information about all the possible risks related to the drug 
  • Information for healthcare workers and points to be discussed with patients before they start the treatment
  • Information on how to use the medication to treat the approved disease/condition 
  • List of specific diseases or conditions that the drug is approved to treat

Many of these medications will have patient information, such as instructions for use, patient package inserts, and medication guides. 

Why Do Doctors Prescribe Medications Off-Label?

Doctors mainly prescribe off-label medicines when patients have exhausted all other approved options or when standard treatment is ineffective. This is often the case with rare diseases or many types of cancer.

The doctor may also have to use off-label medicines if there are no approved medicines for a patient’s condition.

There are numerous instances where off-label use of a drug has been effective. Often off-label use is beneficial and life-saving for some patients. In many cases, off-label use of the drug eventually gets FDA approval. 

You can always ask your physician if you have any doubts regarding the prescribed medication. 

Is Off-Label Use A Medication Error?

Off-label use of the drug is not a medication error. There is scientific logic behind the off-label use of the drug. 

Medication error would be defined as a failure in the treatment process that may cause or potentially harm the patient. These events are usually preventable and often unintentional.  It can occur due to errors from the patient or healthcare professional. 

On the other hand, off-label uses of the drug are rather intentional. It may harm the patient, like in the case of medication error; however, it is often a calculated risk taken by the physician. It is a legal and common practice used by physicians. Besides, off-label use of the drug is always beneficial for the patient.

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What Drugs Are Commonly Used Off-Label and Why?

Physicians prescribe many drugs for their off-label use. Common drugs that are used off-label are as follows:

Class of Drugs / Generic Name of DrugApproved UseOff-Label use
Beta-BlockersHigh blood pressureHeart failure
Tricyclic antidepressantsDepressionChronic pain 
Antipsychotics PsychosisAttention deficit hyperactivity disorder 
Morphine Pain treatment in adultsPain treatment in children
DiphenhydramineAllergyChemotherapy-related emesis, insomnia
AspirinPain killerAntithrombosis in atrial fibrillation, Kawasaki disease
IndomethacinPain killerPharmacologic closure of patent ductus arteriosus
PrazosinHigh blood pressureTreat nightmares related to post-traumatic stress disorder (PTSD) 
Clomiphene Female infertilityMale Infertility
ClonidineHigh blood pressureCancer pain, hot sweats, certain psychiatric disorders, nicotine dependence, opioid withdrawal, migraine headaches, and restless leg syndrome.
QuetiapineTreatment of schizophrenia and bipolar disorderChronic insomnia
PropranololHigh blood pressureTreatment of thyroid storm, portal hypertension, and neuroleptic-induced akathisia.
Sildenafil Treatment of men with erectile dysfunctionFemale sexual arousal disorder.

Off-label drug use is widespread in the case of rare diseases, including certain types of cancer. 

The reason for using off-label drugs

Obtaining new approval from the FDA for a medication is a time-consuming and costly affair.  Generic medicines may not get sufficient funding that is needed to pursue FDA-approved studies. Hence, the manufacturer (proprietor) never seeks FDA approval for new drug indications.  Additionally, the manufacturer (proprietor) needs to file a supplement drug application for an approved medication. Even if approved, the revenues generated for the approved indication may not be worth the effort. 

How often are drugs prescribed off-label?

The use of drugs for their off-label uses is common. About 21% of the prescriptions are for off-label uses.

Does insurance cover Off-label drug use in Canada? 

The insurance cover of the drug depends on various factors, such as private or public payers ready to pay for that medicine. You can consult your doctor and the insurance company to check whether your insurance will covert the prescribed drug or not.

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Is prescribing Off-label illegal?

Off-label use of the drug is controversial, and its safety has attracted much attention. In many countries, it is a legal and prevalent practice. No law inhibits off-label use of the drug in the US and Canada. However, in many countries, off-label drug promotion is not allowed, but it is not prohibited. 

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