"The U.S. Food and Drug Administration today granted accelerated approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa&rsqu"...
Adverse events were evaluated in clinical studies of 647 adults who received 15.0 to 20.0 mCi Technetium Tc 99m labeled to approximately 47µg of depreotide. Of these adults, 58% were men and 42% women. The mean age was 59.0 years (18-86 years).
Deaths did not occur during the clinical study period. After Technetium Tc 99m Depreotide Injection, serious adverse events were not reported.
At least one adverse event occurred in 29/647 (4.5 %) patients after Technetium Tc 99m Depreotide Injection. Headache was the most commonly reported adverse event (1% of patients). Table 8 lists adverse events reported in 0.5% or more of patients who received Technetium Tc 99m Depreotide Injection.
TABLE 8. ADVERSE EVENTS REPORTED IN ≥ 0.5% OF PATIENTS
FOLLOWING NeoTect® (technetium tc 99m depreotide injection) INJECTION IN CLINICAL TRIALS
|Number of Patients Exposed||647|
|Number of Patients with At Least One Adverse Event||29 (4.5%)|
|Nervous System||13 (2%)|
|Gastrointestinal System||7 (1.0%)|
|Vascular (extracardiac) Disorder||3 (0.5%)|
Other adverse events which occurred in < 0.5% of patients following administration of NeoTect® (technetium tc 99m depreotide injection) included: arthrosis, back pain, chest pain, diarrhea, fatigue, gait abnormality, glossitis, hemoptysis, hypoaesthesia, infection, leg cramps, lymphocytosis, malaise, pharyngitis, somnolence, taste perversion.
Read the NeoTect (technetium tc 99m depreotide injection) Side Effects Center for a complete guide to possible side effects
Drug interactions were not noted in clinical studies in which Technetium Tc 99m Depreotide Injection was administered to patients receiving concomitant medication.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/1/2008
Additional NeoTect Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.