Which is an example of a black box warning by the food and drug administration (fda)?

Boxed warnings, also known as black box warnings, are the most serious type of warning issued by the Food and Drug Administration (FDA). These warnings are front and center on a drug’s package insert, on the FDA’s website, and on the pharmaceutical company’s website page for that product (if one exists).

According to the American Family Physician (AAFP), doctors are required to provide patients with information about the relevant risks of a boxed warning drug before prescribing.

The Drug Advisories Are Meant For Doctors

“The purpose of box warnings is to increase prominence of warning to the ‘learned intermediary’ or the physician — not the patient or consumer,” says Theresa Eisenman, a spokesperson for the FDA. “Labeling or prescribing information is designed to make information in prescription drug labeling easier for healthcare practitioners to access, read, and use to make prescribing decisions,” she says.

What Kinds of Adverse Events or Possible Risks Lead to a Boxed Warning?

According to the regulations set by the FDA, one or more of the following scenarios must be present for a drug to receive a black box warning:

• If an adverse event is so serious (death or a permanently disabling reaction) in proportion to the potential benefit from the drug that it is essential to consider when weighing the risks and benefits of the drug

• If a serious adverse reaction can be prevented, reduced in frequency, or made less severe by following certain guidelines, such as patient selection, careful monitoring, or taking into account other medication that the person might be taking

• If there are mandatory restrictions for prescribing the drug. Some medication may only be administered in certain settings (supervised or inpatient) or may require the doctor to complete extra training in order to prescribe

Weighing the Risks vs. Benefits of a Black Box Drug

A black box warning on a drug should not cause a person undue alarm, says Susan Blalock, MPH, PhD, vice chair of pharmaceutical outcomes and policy and a professor at the Eshelman School of Pharmacy in Chapel Hill, North Carolina. “To a large extent, although the risks that are included in black boxes are very serious side effects or potential side effects, there is usually quite a bit of scientific uncertainty associated with them.” Often researchers and the medical community don’t know for certain if the medication causes the side effect that leads to the boxed warning, she says.

Even in cases in which the medication does cause the risk, it can often be a very small risk in comparison with the potential benefits of the drug. “Sometimes we’re talking about something that occurs in 1 in 10,000 people, or 1 in 100,000 people,” she says.

Related: Rheumatoid Arthritis Drugs: Pros and Cons

Consider the Risks of Not Taking a Prescription Medication, Too

There are also risks involved in not taking a prescribed medication, a reality that many people don’t always consider, says Dr. Blalock, pointing to rheumatoid arthritis (RA) as an example. “Even if the pain is controlled, the inflammation from the condition may be doing permanent damage to the heart and lungs if you don’t take the therapy,” she says. “You really need to weigh the risk benefit of both options: of taking a recommended therapy versus not taking it.”

Related: Why Is Early Rheumatoid Arthritis Treatment So Important?

A Doctor’s Perspective on Black Box Warnings For Prescription Medication

“It’s important for people to get all the information on the risks and benefits of a drug with a boxed warning from a conversation with their doctor,” says David Brill, DO, a family medicine doctor in the Cleveland Clinic Health System in Rocky River, Ohio. Many people really wouldn’t know if there is a black box warning on a medication if the physician decides to write the medication and it gets sent into the pharmacy for pick up, he adds.

In Dr. Brill’s experience, most doctors are hesitant to write for anything that has a black box warning. “It’s usually when we’ve gotten to the point where we feel we have no choice — other therapies aren’t working or it’s an urgent situation where we have to use that medication,” he says. “A boxed warning is something that physicians take very seriously.”

How A Black Box Advisory May Influence a Doctor’s Treatment Decisions

Research published in the journal Archives of Internal Medicine supports Brill’s assertion. Researchers examined the use of atypical antipsychotic medication among elderly people with dementia after the FDA issued a black box warning regarding the risk of increased mortality. Over the three-year period after the warning was issued, monthly drug uses for atypicals for that population dropped by more than 50 percent. Researchers concluded that the warning was associated with that decrease.

“If we prescribe a medication with a boxed warning, we have to sit down and talk to the patient about what it means,” he says. “There are different reasons that a drug has a warning. It could be because of interactions with other drugs or it could be a ‘this is a dangerous medicine and should only be used as a last resort’ type warning,” he says.

Black Box Warnings: Not Uncommon, But a Hurdle for Pharmaceutical Companies

“Black box warnings are not new,” says Ed Silverman, senior writer at STAT and Pharmalot columnist. “They’re not placed on every product, but they are not an extreme rarity either. They appear when they do because there are legitimate medical concerns,” he says, adding that the industry sees black box warning as a necessary alert so that physicians use their product correctly.

In a narrow view, a pharmaceutical company wouldn’t want a black box warning — insofar as they wouldn't want anything that might mitigate physicians from writing a lot of prescriptions of the product, says Silverman. “It’s a potential hit to revenue,” he says.

“If product A has a black box warning, and the rival product B does not have a black box warning and they are rather similar in terms of efficacy, product A has a marketing challenge,” he says.

Concerned About a Drug Warning? Talk to Your Doctor

“From my point of view, the patient should be informed by their doctor about the black box warning before taking the drug,” says Brill. If for some reason that doesn’t happen, once you do find out about the warning, speak with your doctor right away. Find out why the drug has a black box and why it’s the right choice and medically necessary, he adds.

Questions to Ask Your Doctor About Treatment Risks

Be proactive, Blalock suggests. “With any sort of warning, but especially a black box warning, you could ask your prescriber, ‘Is there was anything I could do to mitigate the severity or the probability of the adverse event? Is there something I should watch for? What, if any, are the signs or symptoms that an adverse event may occur?’” she says.

Tolerance for Risk Really Varies By Person

“Many of these risks are rare, and yet, people have different tolerances for risk,” says Blalock. “Ultimately, whether to take a drug is a decision for the individual patient to make; how much risk are they willing to tolerate when given objective information from a medical professional.”

Which drugs has a FDA black box warning?

What does Black Label FDA mean?