"Nevro Corp has received an "approvable" letter from the US Food and Drug Administration (FDA) for its spinal cord stimulation (SCS) system for treatment of chronic pain.
The Senza SCS system delivers Nevro's proprietary HF10"...
Retrospective Case Series Experience
The most common adverse reactions (occurring in ≥ 13% of patients), regardless of causality, are: Infections, vomiting, abdominal pain, pyrexia, tonsilitis, anemia, ear infection, diarrhea, nasopharyngitis, and headache.
Table 1 summarizes adverse reactions occurring in 2 or more patients treated with Carbaglu in the retrospective case series. Because these reactions were reported retrospectively, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Table 1: Adverse Reactions Reported in ≥ 2
Patients in the Retrospective Case Series treated with Carbaglu
|System Organ Class Preferred Term||Number of Patients
|Blood and lymphatic system disorders|
|Ear and labyrinth disorders|
|Ear infection||3 (13)|
|Abdominal pain||4 (17)|
|General disorders and administration site conditions|
|Infections and infestations|
|Hemoglobin decreased||3 (13)|
|Weight decreased||2 (9)|
|Metabolism and nutrition disorders|
|Nervous system disorders|
|Skin and subcutaneous tissue disorders|
Read the Carbaglu (carglumic acid tablets) Side Effects Center for a complete guide to possible side effects
No information provided.
Last reviewed on RxList: 8/16/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Carbaglu Information
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