The FDA has added a Black Box warning to the popular drug montelukast (brand name Singulair). A black box warning is one of FDA’s most significant label warnings, and in this case, there are recommendations to potentially change therapeutic decisions based on the severity of the diseases and the potential risk benefit The new warning […]
In a very recent safety communication, due to an increase in serious bowel issues from severe constipation to complete bowel obstruction that have been reported for Clozaril, the FDA is alerting the public and health care providers of this new information. The communication notes that this adverse event can, in some patients, be serious and […]
The Agency issued two warnings today, one about a recall due to a drug-strength labeling error for Mirtazapine and the other regarding a potential serious adverse event, breathing difficulties, associated with the use of gabapentinoids. It appears that there was a label mix-up with a single lot of Mirtazapine and “Aurobindo Pharma USA, Inc. is […]
