"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
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.
|COMPLICATIONS OF PREMATURITY|
|CUROSURF (poractant alfa) 2.5 mL/kg
|Patent Ductus Arteriosus||60||48|
|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 Curosurf (poractant alfa) Side Effects Center for a complete guide to possible side effects
No information provided.
Last reviewed on RxList: 12/4/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Curosurf Information
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