US FDA invokes authority to order ESA labelling changes
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Reactions 1214 - 9 Aug 2008 US FDA invokes authority to order ESA labelling changes For the first time, the US FDA has invoked authority under legislation adopted in 2007 * to order changes to the labelling for Amgen’s erythropoiesis-stimulating agents (ESAs) darbepoetin-α and epoetin-α. 1 Amgen and the FDA have agreed on many of the safety-related changes to the labelling of these products, including replacing the current Patient Package Insert with a Medication Guide and modifying particular sections of the Boxed Warnings, Indications and Usage, and Dosage and Administrations sections of the package insert. 1 However, the two parties have failed to agree on specific wording for a warning statement and for statements regarding when to start and discontinue ESAs. Consequently, the agency has issued labelling change orders for darbepoetin-α [Aranesp] and epoetin- α [Epogen/Procrit]. 2, 3 In addition to the agreed changes, the FDA is ordering the following changes be made: • In the Boxed Warnings and Indications and Usage sections, statements that darbepoetin-α and epoetin-α are "not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure" should be used in place of the company’s proposed statements for these two ESAs. • The qualifying statements (in italics) must be removed from the Dosage and Administration: Cancer Patients Receiving Chemotherapy subsections for both ESAs:|| a. Therapy should not be initiated at hemoglobin levels ≥ 10 g/dL, except where the patient is unable to tolerate this degree of anemia due to co-morbid conditions.|| b. Withhold Dose if: Hemoglobin exceeds a level needed to avoid transfusions or exceeds 12 g/dL. The removal of the qualifying statements was deemed necessary as they undermine other components of dosing directions instructing healthcare providers to maintain the lowest haemoglobin necessary to avoid RBC transfusions. * section 505(o)(4) of the Food, Drug and Cosmetic Act 1. FDA. Follow up to the January 3, 2008 communication about an ongoing safety review erythropoiesis-stimulating agents (ESAs) epoetin alfa (marketed as Procrit, Epogen) darbepoetin alfa (marketed as Aranesp). Internet Document : [3 pages], 22 Apr 2008. Available from: URL: http://www.fda.gov. 2. FDA. Complete response and safety labeling change order. Internet Document : [4 pages], 22 Apr 2008. Available from: URL: http://www.fda.gov. 3. FDA. Complete response and safety labeling change order. Internet Document : [5 pages], 22 Apr 2008. Available from: URL: http://www.fda.gov. 801075328 1 Reactions 9 Aug 2008 No. 1214 0114-9954/10/1214-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved
Transcript of US FDA invokes authority to order ESA labelling changes
Reactions 1214 - 9 Aug 2008
US FDA invokes authority to orderESA labelling changes
For the first time, the US FDA has invoked authorityunder legislation adopted in 2007* to order changes tothe labelling for Amgen’s erythropoiesis-stimulatingagents (ESAs) darbepoetin-α and epoetin-α.1
Amgen and the FDA have agreed on many of thesafety-related changes to the labelling of these products,including replacing the current Patient Package Insertwith a Medication Guide and modifying particularsections of the Boxed Warnings, Indications and Usage,and Dosage and Administrations sections of the packageinsert.1 However, the two parties have failed to agree onspecific wording for a warning statement and forstatements regarding when to start and discontinueESAs. Consequently, the agency has issued labellingchange orders for darbepoetin-α [Aranesp] and epoetin-α [Epogen/Procrit].2, 3 In addition to the agreed changes,the FDA is ordering the following changes be made:• In the Boxed Warnings and Indications and Usage
sections, statements that darbepoetin-α andepoetin-α are "not indicated for patients receivingmyelosuppressive therapy when the anticipatedoutcome is cure" should be used in place of thecompany’s proposed statements for these two ESAs.
• The qualifying statements (in italics) must beremoved from the Dosage and Administration:Cancer Patients Receiving Chemotherapysubsections for both ESAs:|| a. Therapy should notbe initiated at hemoglobin levels ≥ 10 g/dL, exceptwhere the patient is unable to tolerate this degree ofanemia due to co-morbid conditions.|| b. WithholdDose if: Hemoglobin exceeds a level needed toavoid transfusions or exceeds 12 g/dL.
The removal of the qualifying statements was deemednecessary as they undermine other components ofdosing directions instructing healthcare providers tomaintain the lowest haemoglobin necessary to avoidRBC transfusions.* section 505(o)(4) of the Food, Drug and Cosmetic Act
1. FDA. Follow up to the January 3, 2008 communication about an ongoing safetyreview erythropoiesis-stimulating agents (ESAs) epoetin alfa (marketed asProcrit, Epogen) darbepoetin alfa (marketed as Aranesp). Internet Document : [3pages], 22 Apr 2008. Available from: URL: http://www.fda.gov.
2. FDA. Complete response and safety labeling change order. Internet Document :[4 pages], 22 Apr 2008. Available from: URL: http://www.fda.gov.
3. FDA. Complete response and safety labeling change order. Internet Document :[5 pages], 22 Apr 2008. Available from: URL: http://www.fda.gov.
801075328
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Reactions 9 Aug 2008 No. 12140114-9954/10/1214-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved
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