A boxed warning on a drug's label calls attention to serious or life-threatening risks.

This challenges the idea that physicians and patients will have a conversation after a boxed warning is issued.

Xarelto has a boxed warning to make clear that people using the drug should not discontinue it before talking with their health care professional.

Fluoxetine has a boxed warning about an increased risk of suicide in young adults aged less than 25 years.

It is important to note that none of the studies that led to the boxed warning included or focused on patients being treated for cancer.

The Elaprase label includes a boxed warning with information on the potential for hypersensitivity reactions.

Ms. Green suggested consolidating them and highlighting the heart risks with a boxed warning, the agency's most severe.

The FDA required the manufacturers to add a boxed warning to the products to alert patients and doctors to the potential risk.

It is not necessarily true that a physician and patient will have a conversation about a drug's boxed warning after it is issued.

Fycompa's label has a boxed warning to alert prescribers and patients about the risk of serious neuropsychiatric events.