Brexpiprazole, like other drugs used to treat schizophrenia, will carry a boxed warning
alerting health care professionals about an increased risk of death with off-label use for treating behavioral problems in older persons with dementia-related psychosis.
In an Immediately in Effect (IIE) guidance, the FDA is also recommending that manufacturers of laparoscopic power morcellators include in their product labeling specific safety statements in the form of a boxed warning
and two contraindications.
A BOXED WARNING
ABOUT POTENTIAL PSYCHIATRIC and nerve effects has been added to the label for the antimalarial agent mefloquine hydrochloride.
30, 2013 /PRNewswire/ -- Food and Drug Administration (FDA) announced the requirement of a Boxed Warning
for the anti-cancer immunosuppressive drugs Arzerra (ofatumumab) and Rituxan (rituximab).
The pioglitazone label has a boxed warning
stating that treatment with TZDs, including pioglitazone, can cause or exacerbate heart failure, and that patients on treatment with pioglitazone should be monitored closely for heart failure; it is contraindicated in patients with New York Heart Association (NYHA) III or IV heart failure.
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.
Botox includes a boxed warning
about the rare possibility that the botulinum toxin may spread from the area of injection to other areas of the body, causing botulism-like symptoms, which can be life-threatening.
Propoxyphene-containing products, sold as Darvon, Darvocet or in generic form, must add a boxed warning
about the risk of excess use, the FDA's strictest caution.
The FDA has announced labeling changes, including a boxed warning
, to highlight the risks of life-threatening infections with the use of Raptiva (efalizumab).
A boxed warning
about an increased suicidality risk with the use of antiepileptic drugs should not be added to the labels of drugs in this class, but patients prescribed these drugs should receive information about this risk with every prescription, according to the majority of two federal advisory panels.
Food and Drug Administration today announced the addition of a boxed warning
to the label of Regranex Gel 0.
Food and Drug Administration has asked manufacturers to include a new boxed warning
on the product labeling of all gadolinium-based magnetic resonance contrast agents.