Liquid Leukine Withdrawn Following Side Effect Reports. Leukine Shortage Feared.Jan 24, 2008 | Parker Waichman LLP
Liquid Leukine, a drug used to reduce infections in people undergoing chemotherapy for acute myelogenous leukemia (AML) has been withdrawn from the market by Bayer HealthCare Pharmaceuticals following a jump in side effect reports, including fainting. According to the Food & Drug Administration (FDA) alert on the liquid Leukine withdrawal, the increase in adverse reactions correlated with the addition of edetate disodium to the formulation of liquid Leukine. The liquid Leukine withdrawal will have serious implications for patients who need this lifesaving drug, as supplies of other formulations of Leukine are limited.
Leukine is a hematopoietic agent, and works by stimulating production of white blood cells in bone marrow. Liquid Leukine is used to reduce severe, life-threatening, or fatal infections after chemotherapy for AML. It is also used to help increase the success of autologous bone marrow transplant and to help increase survival in patients who have bone marrow transplant failure. Leukine is the only myeloid growth factor approved for these purposes.
According to a letter Bayer sent to physicians concerning the liquid Leukine withdrawal, the addition of edentate disodium to the Leukine formulation coincides with increased reports of adverse events. Edetate Disodium was approved many years ago as an emergency treatment for certain patients with a condition called hypercalcemia (very high levels of calcium in the blood) or certain patients with heart rhythm problems as a result of very high amounts of digitalis in the blood. Earlier this month, the FDA issued a public health alert for edetate disodium after it was linked to several deaths. According to the FDA, some of the edetate disodium deaths occurred when the drug was mistaken for edetate calcium disodium, or when it was used in chelating therapy. As a result of these problems, the FDA said it is reviewing the benefit/risk profile of Edetate Disodium to determine if the benefits for its intended use continue to outweigh the serious risks.
Bayer will no longer be filling or shipping orders for the current formulation of liquid Leukine. Bayer has requested that healthcare professionals with stocks of liquid Leukine stop using it immediately, and return it to Bayer.
Bayer said it has not seen an increase in adverse event reports related to lyophilized Leukine, which does not contain edetate calcium. However, there are insufficient quantities of lyophilized Leukine available to meat demand. For that reason, it has established a special access program for lyophilized Leukine. The special access program will give priority to oncologists and hematologist who treat patient with AML, as well as those experiencing bone marrow failure or engraftment delay. Bayer said it will be working to increase supplies of the lyophilized Leukine, and to reformulate liquid Leukine to eliminate edetate disodium.
Patients or healthcare professionals about the liquid Leukine withdrawal may contact Bayer at 1-888-84BAYER.