NeoProfen (Ibuprofen Lysine Injection) Drug Information: Side Effects and Drug Interactions

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May 27, 2012

NeoProfen

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SIDE EFFECTS

Clinical Trials

The most frequently reported adverse events with NeoProfen (ibuprofen lysine injection) were as shown in Table 1.

Table 1. Adverse Events within 30 Days of Therapy in the Multicenter Study*

Adverse Event	% Incidence
Adverse Event	NeoProfen	Placebo
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
Within 30 days of therapy, with an event rate greater on NeoProfen (ibuprofen lysine injection) than on placebo, and greater than 2 events on NeoProfen (ibuprofen lysine injection) . *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.

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 reactions have been identified from spontaneous post-marketing reports or published literature: gastrointestinal perforation and necrotizing enterocolitis. 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.