A boxed warning is the most serious warning by the Food and Drug Administration (FDA). Its purpose is to alert people about drug effects that may be dangerous.
Boxed warnings apply to certain medications that carry serious risks for the person taking them. The FDA decides which medications require boxed warnings.
A doctor must review the risks and benefits of a medication with a boxed warning before prescribing it. They will decide whether a medication is safe to prescribe based on a person’s health conditions, any medications they take, and other important factors.
This article will discuss boxed warnings, the types of medications that have boxed warnings, and how to discuss risks with a doctor.
The FDA requires that medications undergo rigorous testing before it allows them to enter the market for prescription use. This is because safety is a priority for any new drug.
The general drug development process is
- laboratory research
- preclinical research, including animal testing and basic safety tests
- clinical research, also known as human trials
- review, in which the FDA decides whether to approve the new drug
- post-marketing safety monitoring
Using the information gathered from this process, the FDA will decide whether a drug requires a boxed warning. Specifically, the
The FDA can apply a boxed warning to a drug
Doctors may sometimes refer to boxed warnings as black box warnings. This is because boxed warnings come with a black box around them on the medication packaging and paperwork.
According to 2022 research, over 400 medications currently carry boxed warnings.
The FDA assigns boxed warnings to products that carry risks of death or serious injury. Different drugs can cause these outcomes in different ways. Because of this, a person taking a medication that has a boxed warning should talk with a doctor about any side effects they experience.
Some examples of drugs and drug classes that carry boxed warnings are below. It is important to note that this is not a complete list. Anyone who would like more information about boxed warnings can speak with a doctor or healthcare professional.
Commonly prescribed medications in the benzodiazepine drug class include:
- alprazolam (Xanax)
- clonazepam (Klonopin)
- diazepam (Diastat, Valium, others)
- lorazepam (Ativan)
- triazolam (Halcion)
Potentially life threatening reactions associated with benzodiazepines include:
- thoughts of harming others
- suicidal thoughts or behaviors
If you know someone at immediate risk of self-harm, suicide, or hurting another person:
- Ask the tough question: “Are you considering suicide?”
- Listen to the person without judgment.
- Call 911 or the local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.
- Stay with the person until professional help arrives.
- Try to remove any weapons, medications, or other potentially harmful objects.
If you or someone you know is having thoughts of suicide, a prevention hotline can help. The 988 Suicide and Crisis Lifeline is available 24 hours a day at 988. During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 988.
Commonly prescribed medications in the antidepressant drug class include:
Additionally, the update referenced risks associated with IR opioid pain medications when taken by people who are pregnant. A serious condition called neonatal opioid withdrawal syndrome can occur in newborns exposed to opioids as a fetus.
Commonly prescribed medications in the opioid drug class include:
- codeine (Prometh VC)
- fentanyl (Actiq, Fentora, others)
- hydrocodone (Vicodin, others)
- morphine (MS Contin, others)
- oxycodone (OxyContin, Percocet, others)
If a person develops a physical dependence on an opioid drug, doctors refer to it as opioid use disorder. As a person’s tolerance for the drug increases, they may begin to take larger doses. This increases the risk of overdose occurring, which can be fatal.
Certain JAK inhibitors
The FDA did not study other JAK inhibitors to the same extent as those above, so experts do not know whether they carry the same risks. However, as all JAK inhibitors work similarly, the FDA notes that the risks associated with them may be similar.
Before starting a new medication, it is important for a person to talk with a doctor about how the medication may affect them.
Some medications can cause others to have a different effect than expected. For example, they may make the medication work less effectively in the body or increase the risk of side effects.
For example, the antidepressant sertraline (Zoloft) affects serotonin production in the brain. If a person takes another medication that affects serotonin, the two can interact, leading to a serious condition known as serotonin syndrome.
If a person has a certain medical condition, taking a medication that affects that system or part of the body can cause severe side effects. Clonazepam (Klonopin) treats panic disorder and seizures. If a person takes it with an opioid, they risk severe drowsiness, slowed breathing, coma, and death.
In addition to talking with a doctor, it is important to thoroughly read the packaging and paperwork of any new medication before taking it and discuss any concerns with a healthcare professional.
A boxed warning is a serious warning from the FDA. Products assigned a boxed warning carry risks of severe harm or death. Medications that have boxed warnings can be effective treatment options in some cases, but there are potential complications to consider before starting treatment.
A doctor will evaluate the risks and benefits of a medication with a boxed warning before prescribing it. If a person has any concerns or questions about starting a new medication, it is important to discuss them with a healthcare professional.