The administration approved these changes, including adding its most prominent Boxed Warning
, after reviewing interim data from an ongoing safety clinical trial of tofacitinib in patients with rheumatoid arthritis that examined a lower and this higher dose of the medicine, it said.
Its label contains the harshest form of a boxed warning
that highlights several health risks including liver damage and a rare form of serious brain infection.
The Food and Drug Administration has eliminated the boxed warning
for risk of asthma-related death from the labels of products containing both an inhaled corticosteroid and a long-acting beta agonist, the agency announced.
AstraZeneca PLC has been cleared by the Food and Drug Administration to update the label for Symbicort inhalation aerosol (budesonide/formoterol fumarate dihydrate), including removal of the boxed warning
for serious asthmarelated outcomes.
A retrospective study of 362,992 children aged 0-18 years who underwent tonsillectomy and/or adenoidectomy was undertaken in 2010-2015, prior to and after the FDA issued the boxed warning
against codeine use.
The Food and Drug Administration has added a boxed warning
to the label of diabetes drug canagliflozin for the risk of lower limb amputation.
The prescribing information includes a boxed warning
about the risk of serious infections associated with its use; that boxed warning
also includes a statement that lymphoma and other malignancies, "some fatal, have been reported in children and adolescent patients treated with TNF blockers, including Enbrel."
Of the 19 voting advisory committee members, 10 voted in favor of eliminating the boxed warning
, while 4 members voted for a modification of the existing boxed warning
, and 5 voted to retain the warning.
The agency initially limited its boxed warning
to extended-release opioids because they contain more drug per tablet, are more attractive to substance abusers, and have a longer temporal risk of potentially fatal respiratory depression, Dr.
A BOXED WARNING
ABOUT POTENTIAL PSYCHIATRIC and nerve effects has been added to the label for the antimalarial agent mefloquine hydrochloride.
The drug carries a Boxed Warning
for an increased risk of developing post-transplant lymphoprolifterative disorder (PTLD), a type of cancer where white blood cells grow out of control after an organ transplant.