Curosurf
FDA Approves Dotarem, a New MRI Agent »
"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
Dotarem is a gadolinium-based"...
Curosurf
Curosurf Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Curosurf FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Transient adverse effects seen with the administration of CUROSURF (poractant alfa) include bradycardia, hypotension, endotracheal tube blockage, and oxygen desaturation. Pulmonary Hemmorhage is a known complication of premature birth and very low birth-weight and has been reported both in clinical trials with Curosurf (poractant alfa) and in post-marketing adverse event reports in infants who had received Curosurf (poractant alfa) . The rates of common complications of prematurity observed in Study 1 are shown below in Table 3.
TABLE 3
| COMPLICATIONS OF PREMATURITY | ||
| CUROSURF (poractant alfa) 2.5 mL/kg (200 mg/kg) n=78 % |
CONTROL * n=66 % |
|
| Acquired Pneumonia | 17 | 21 |
| Acquired Septicemia | 14 | 18 |
| Bronchopulmonary Dysplasia | 18 | 22 |
| Intracranial Hemorrhage | 51 | 64 |
| Patent Ductus Arteriosus | 60 | 48 |
| Pneumothorax | 21 | 36 |
| Pulmonary Interstitial Emphysema | 21 | 38 |
| * Control patients were disconnected from the ventilator and manually ventilated for 2 minutes. No surfactant was instilled. | ||
Immunological studies have not demonstrated differences in levels of surfactant-anti-surfactant immune complexes and anti-CUROSURF (poractant alfa) antibodies between patients treated with CUROSURF (poractant alfa) and patients who received control treatment.
Follow -Up Evaluations
Seventy-six infants (45 treated with CUROSURF (poractant alfa) ) were evaluated at 1 year of age and 73 infants (44 treated with CUROSURF (poractant alfa) ) at 2 years of age. Data from follow-up evaluations for weight and length, persistent respiratory symptoms, incidence of cerebral palsy, visual impairment, or auditory impairment was similar between treatment groups. In 16 patients (10 treated with CUROSURF (poractant alfa) and 6 controls) evaluated at 5.5 years of age, the developmental quotient, derived using the Griffths Mental Developmental Scales, was similar between groups.
Read the entire FDA prescribing information for Curosurf (Poractant Alfa) »
Additional Curosurf 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.
Women's Health
Find out what women really need.
Updated & New
