We need not only a black-box warning on antidepressants, but also a new strategy for the effective delivery of adolescent mental health care.
Until then, doctors will have to decide whether they want to go up against a black-box warning.
Also emphasized by the "black-box" warning is that estrogen products are not approved for heart disease prevention.
The drugs already carry a black-box warning that they may cause cancer.
This led to the black-box warning on all LABA-containing drugs.
The so-called black-box warnings will appear in boldface type, framed by a black border, on information sheets for patients and doctors.
The agency has yet to make final the language of the patient medication guides, but the wording of the black-box warning is stark.
In other ads, the entire black-box warning must be either prominently printed on the ad or, for radio and television, spoken clearly during the commercial.
Right now, all estrogens carry the same black-box warning with respect to clot formation.
We see a slowdown in approval rates, and a dramatic increase in black-box warnings for drugs.
