Baxter Healthcare Corporation made a public announcement in August that it is updating certain sections of the prescribing information for FEIBA VH® and FEIBA NF®after consistent reports of thrombosis (excessive clots forming in blood vessels) and thromboembolic events associated with the use of the products, particularly in high doses or in at-risk patients. Thromboembolic events are serious side effects. If untreated, these clots can become dislodged and travel to the lungs, brain or other major organs. In some cases, they can be fatal.
FEIBA VH® and FEIBA NF® are plasma-derived products indicated for the control of spontaneous bleeding episodes or to cover surgical interventions in hemophilia A and hemophilia B patients with inhibitors. The updates have been made under the section, “CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS” in the prescribing information for both products. Baxter is working with the U.S. Food and Drug Administration (FDA) to alert the community.
It should be noted that the risks for thrombosis-related complications with FEIBA products are not new. Rates have remained steady since the product was licensed in the U.S. in 1986. While the risks are well established, post-marketing reports and the subsequent data gathered have enabled Baxter to elaborate on which patients might be more predisposed to hazardous clots, now reflected in the updated prescribing information. The cautionary information will appear in a black box warning on the label.
If you have questions or concerns about FEIBA VH® or FEIBA NF®, contact Baxter Medical Information: 1.866.424.6724 (phone); 1.800.278.8704 (fax);[email protected] (e-mail).
Baxter encourages anyone who suspects adverse advents to report them to the FDA’s MedWatch reporting system through one of the following channels: 1.800.FDA-1088 (phone;); 1-800-FDA-0178 (fax), www.fda.gov/medwatch (online). By mail: Use MedWatch FDA 3500 postage paid form, to the FDA Safety Information and Adverse Event Reporting Program, 5600 Fishers Lane, Rockville, MD 20852-9787.
Read the FEIBA VH® and FEIBA NF®alert.
