The drugs’ active ingredient, glatiramer acetate, has been linked to more than 80 cases of anaphylaxis worldwide since ...
Reports of anaphylaxis associated with the use of glatiramer acetate have prompted the Food and Drug Administration (FDA) to add a Boxed Warning to the prescribing information.
Regulatory officials have identified 82 cases worldwide from the FDA Adverse Event Reporting System of anaphylaxis associated ...
After years of legal wrangling surrounding Teva’s Copaxone, the latest hit to the lucrative multiple sclerosis drug comes in the form of a safety-related boxed warning. The label update ...
The US Food and Drug Administration (FDA) is adding the risk of anaphylaxis to a new boxed warning of glatiramer acetate, a medicine for multiple sclerosis (MS). The agency issued the warning ...
As with other drugs, Rapamune can cause side effects. Rapamune has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the ...
The National Transportation Safety Board released photos of the charred black box from the air ambulance crash that occurred ...
The US Food and Drug Administration (FDA) is adding the risk of anaphylaxis to a new boxed warning of glatiramer acetate, a ...
Ciprofloxacin has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Ciprofloxacin’s side effects explained” section.
Empaveli has a boxed warning. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Boxed warning for Empaveli” section. Empaveli can ...
A cross-sectional comparative evaluation of the boxed warning in the manufacturer's PI and the boxed warning content in six online drug information resources was conducted. The selected resources ...
The new warnings need to be printed at the start of information leaflets given to both patients and health-care providers (sometimes called a“boxed” warning). So why did the TGA issue this ...