" Citing a lack of cardiovascular benefit, the FDA is taking the unusual step of withdrawing approvals it had previously given for use of niacin and fenofibric acid with statins to treat high cholesterol.
The decision affects niac"...
- Inform patients of the early signs of hypersensitivity reactions to Zemaira (including hives, generalized urticaria, tightness of the chest, dyspnea, wheezing, faintness, hypotension, and anaphylaxis). Advise patients to discontinue use of Zemaira and contact their physician and/or seek immediate emergency care, depending on the severity of the reaction, if these symptoms occur [see WARNINGS AND PRECAUTIONS].
- Inform patients that because Zemaira is made from human blood, it may carry a risk of transmitting infectious agents (e.g., viruses and, theoretically, the CJD agent) [see WARNINGS AND PRECAUTIONS].
- Inform patients that administration of Zemaira has been demonstrated to raise the plasma level of A1-PI, but that the effect of this augmentation on the frequency of pulmonary exacerbations and on the rate of progression of emphysema has not been established by clinical trials.
- Dizziness may occur following the administration of Zemaira, therefore, patients should exercise caution immediately following an infusion.
Last reviewed on RxList: 3/18/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Zemaira Information
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