FDA Safety Labeling Changes: NephrAmine and Neumega

Yael Waknine

August 25, 2004

Aug. 25, 2004 — The U.S. Food and Drug Administration (FDA) approved in May revisions to drug safety labeling to advise healthcare professionals of the following changes: 5.4% amino acid injection may cause aluminum toxicity in patients with impaired kidney function; oprelvekin is toxic after myeloablative chemotherapy and can cause serious or fatal fluid retention.

5.4% Amino Acid Injection (NephrAmine) May Cause Aluminum Toxicity in Patients With Impaired Kidney Function

On May 5, the FDA approved revisions to the safety labeling for 5.4% essential amino acid injection (NephrAmine, made by B. Braun), warning that the product contains aluminum that may reach toxic levels with prolonged parenteral administration in patients with impaired kidney function.

Premature neonates are particularly at risk because they have immature kidneys and require large amounts of calcium and phosphate solutions that contain aluminum.

According to the FDA, research has shown that renally impaired patients receiving parenteral levels of aluminum greater than 4 to 5 µg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

The FDA emphasizes the need for knowledge of nutrition as well as clinical expertise in the recognition and treatment of complications, and the agency recommends careful monitoring of central venous nutrition with frequent clinical and laboratory evaluations.

Laboratory tests should include measurement of blood sugar, electrolyte, and serum protein concentrations; kidney and liver function tests; and evaluation of acid-base and fluid balances.

The 5.4% amino acid injection is indicated for use in conjunction with other measures to provide nutritional support for adult and pediatric uremic patients when oral nutrition is not feasible or is impractical.

Oprelvekin (Neumega) May Cause Serious/Fatal Fluid Retention After Myeloablative Therapy

On May 25, the FDA approved revisions to the safety labeling for oprelvekin (Neumega, made by Wyeth Pharmaceuticals, Inc.) to include the warning that the product is not indicated after myeloablative chemotherapy and has been shown to have toxic adverse effects.

According to the FDA, results of a randomized controlled study showed that oprelvekin was not effective after myeloablative chemotherapy, and its use was associated with a statistically significant increase in incidence of edema, conjunctival bleeding, hypotension, and tachycardia compared with placebo.

Oprelvekin is known to cause serious fluid retention that can result in peripheral edema, dyspnea on exertion, pulmonary edema, capillary leak syndrome, atrial arrhythmias, and exacerbation of preexisting pleural effusions.

The FDA has received postmarketing reports of severe fluid retention, in some cases fatal, after bone marrow transplantation in patients administered oprelvekin.

Oprelvekin is indicated in the prevention of severe thrombocytopenia and to reduce the need for platelet transfusions after myelosuppressive chemotherapy in adult patients with nonmyeloid malignancies.

Reviewed by Gary D. Vogin, MD

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