Significados de box warning em inglês

The FDA put a black- box warning on Celebrex that reads as follows:

The FDA issued a long black- box warning for them, which reads in part:

The FDA removed the black box warning a few months later.

He voted to remove the black box warning.

A company spokeswoman said the so-called black- box warning did not preclude the company from conducting direct-to-consumer advertising.

Public Citizen successfully sued the FDA in 2008 to require that black box warning on the fluoroquinolones.

This drug was issued a black- box warning by the FDA due to the risk of anaphylaxis previously mentioned.

The advisory panel of medical experts in September 2016 recommended in a close vote to remove the black box warning.

Nuplazid may also have to carry a black box warning, but this is unlikely to affect its adoption, analysts have said.

The new, and more-serious, black- box warning includes additional language regarding screening and monitoring patients for tuberculosis, the companies said in a release.

In March, FDA officials ordered a new, black- box warning for the medicines' labels and called on doctors to use the lowest dose possible.

But the drug, Merrimack's first to win regulatory clearance, carries a black box warning, FDA's most severe and restrictive warning on a product.

The drug already carries one FDA black box warning for another condition, heart failure -when a weakened heart cannot pump blood effectively.

In a statement, the South San Francisco-based biotech said it was still discussing the request for a so-called black box warning with the FDA.

The FDA now requires the drug to carry a "black- box warning," the strongest type of warning for an FDA-approved drug, on its label.

The drug comes with a boxed warning, FDA's harshest type of warning.