ADVERSE REACTIONS
The most frequently reported adverse events with NeoProfen were as shown in Table 2.
Table 2. Adverse Events within 30 Days of Therapy in the Multicenter Study* | % Incidence |
|---|
| Adverse Event | NeoProfen | Placebo |
| *Within 30 days of therapy, with an event rate greater on NeoProfen than on placebo, and greater than 2 events on NeoProfen. |
| **A given subject may have experienced more than one specific event within these adverse event categories. Only the most severe grade of IVH counted for a given subject. |
| Sepsis | 43 | 37 |
| Anemia | 32 | 25 |
| Total Bleeding** | 32 | 29 |
| Intraventricular Hemorrhage, Grades 1/2 | 15 | 13 |
| Intraventricular Hemorrhage, Grades 3/4 | 15 | 10 |
| Other Bleeding | 6 | 13 |
| Intraventricular Hemorrhage, All Grades | 29 | 24 |
| Apnea | 28 | 26 |
| Gastrointestinal Disorders | 22 | 18 |
| non-Necrotizing Enterocolitis | | |
| Total Renal Events** | 21 | 15 |
| Renal Failure | 1 | 3 |
| Renal Insufficiency, Impairment | 6 | 4 |
| Urine Output Reduced | 3 | 1 |
| Blood Creatinine Increased | 3 | 1 |
| Blood Urea Increased with Hematuria | 1 | 1 |
| Blood Urea Increased | 7 | 4 |
| Respiratory Infection | 19 | 13 |
| Skin Lesion/Irritation | 16 | 6 |
| Hypoglycemia | 12 | 6 |
| Hypocalcemia | 12 | 9 |
| Respiratory Failure | 10 | 4 |
| Urinary Tract Infection | 9 | 4 |
| Adrenal Insufficiency | 7 | 1 |
| Hypernatremia | 7 | 4 |
| Edema | 4 | 0 |
| Atelectasis | 4 | 1 |
Renal Function
Compared to placebo, there was a small decrease in urinary output in the ibuprofen group on days 2-6 of life, with a compensatory increase in urine output on day 9. In other studies, adverse events classified as renal insufficiency including oliguria, elevated BUN, elevated creatinine, or renal failure were reported in ibuprofen treated infants.
Additional Adverse Events
The adverse events reported in the multicenter study and of unknown association include tachycardia, cardiac failure, abdominal distension, gastroesophageal reflux, gastritis, ileus, inguinal hernia, injection site reactions, cholestasis, various infections, feeding problems, convulsions, jaundice, hypotension, and various laboratory abnormalities including neutropenia, thrombocytopenia, and hyperglycemia.
Post-marketing Experience
The following adverse reaction has been identified from spontaneous post-marketing reports or published literature: gastrointestinal perforation. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency, or establish a causal relationship to drug exposure.
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