What Are the Risks of Off-Label Drug Use?

Some drugs are considered ‘off-label,’ when they are prescribed for a purpose other than those approved by the FDA. They may also be found in package labels but not always used properly. The package insert describes the drug, approved uses, and possible side effects. Risks of using off-label drugs vary, but there can be some challenges for people who use it other than prescribed.

Why it Happens

When drugs are prescribed off-label, the FDA is not approving them for that use in particular. Trazodone, for instance, is a drug approved by the FDA as an antidepressant. Drowsiness is a side effect. Trazodone is associated with other things, too, but the greater risk is in elderly people who use the drug. Off-label drug use is often a benefit but prescriptions written in this way are not always efficacious for people. They are not suggested for certain uses because they may be a risk of dependence or overdose if improperly used.

Safety Concerns

Off-label drug use is considered safe because doctors are familiar with drugs and dosing, so they normally are not worried. When drugs are used off-label with no evidence to back up use, the side effects can increase. A doctor may prescribe to children, too, and they use drugs for pediatric concerns or need help with mental health conditions such as depression or schizophrenia. Cancer drugs are used quite often as off-label drugs but that does not usually approve combinations of drugs. Many drugs used for cancer treatment are given together. Off-label prescribing can have downsides, including:

  • Serious side-effects
  • Adverse outcomes like death for people who have dementia and use antipsychotic drugs, for example
  • Codeine was off-label for years to use for children in surgery but the FDA reported liver enzymes were at risk for depressed breathing or fatal adverse effects after use
  • Children under 12 should not use codeine at all due to warnings from off-label use
  • Existing risk factors can put people at a higher risk for situations to occur, even if they don’t know about it beforehand

Research on the use of drugs in children should be a priority. Children should be seen as a priority, along with other people who need pain management. People trust their providers to make sure they get the best treatment possible. Cancer treatments should be made available to people so they understand what is going on. Everyone can be safer when they know the risks and potential harm caused by the drugs they are given, which are supposed to help them feel better.

At the Last Resort, you can come to find your healing place. We will be a space that is made for you to be vulnerable, open up about addiction, and finally move forward in recovery. We let you find your own way back to yourself with the help of specialists who support your journey as an individual one with communal support. Call us to find out more: 512-750-6750.