From:	Pomije, Brian D. (LCDR)
Sent:	Monday, December 05, 2005 12:18 PM
To:	Burke, Gerald; Clark, Dorothy M. (CIV); Ely, Karen D. (CIV); Fairchild Gregory R LT; Feightner, Michael P. LT; Fong, Raynard K   CAPT; Frampton, Scott W  CIV; Giel, Daniel T. (CIV); Hecht, Sheila C , LCDR; Houston, Tony L. HM2; Johnson, Gabrielle M.; LaFontaine, Richard L CT; Loscocco, Michele F (CDR); Ozeroglu, Muhammed A  LT; Pomije, Brian D. (LCDR); Ruiz, Steven LCDR; Scott, John H., CIV.; Simays, Andrew E., CDR; Solanki, Haresh P; Swilley, Eugene A. (LT); Tu, Victor LT; Van Way, Rick L (LCDR); Younes, Georges  E LCDR
Cc:	Clagett, Christopher D, CDR; Rudolph, W. Garry (CAPT); Fallon, Ann P. (CAPT); Pomije, Brian D. (LCDR); Ely, Karen D. (CIV); Clark, Dorothy M. (CIV); Earles, Marvin R LCDR ; Glennon, Brendan K. CDR BUMED; Lino CDR Fragoso (E-mail) (Lino.Fragoso@navy.mil); Hutto, Robert CAPT; Lorenzen, William F GS; Netzer, Patricia H. (CAPT); Styles, Donna L (CAPT)
Subject:	FDA MedWatch: Life-Threatening Events, Mallinckrodt and Palatin, NeutroSpec [Technetium (99m Tc) fanolesomab]

Importance:	High
To all Medical Radiation Safety Officers and NRMP Permittees:
The following information is being forwarded for informational purposes.  Please ensure that this message is distributed to your Nuclear Medicine Authorized User (AU) physicians and other Nuclear Medicine staff as appropriate.
V/r,
LCDR Pomije

Brian D. Pomije, MS, DABR
Lieutenant Commander, Medical Service Corps, USN
Radiation Health Team Leader
Navy Environmental Health Center
620 John Paul Jones Circle (Suite 1100)
Portsmouth, VA 23708-2103

W: (757) 953-0766; DSN: 377-0766
Cell: (757) 651-2814
Fax: (757) 953-0685
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Life-Threatening Events, Mallinckrodt and Palatin, 
NeutroSpec [Technetium (99m Tc) fanolesomab] 

FDA MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Mallinckrodt, Palatin Technologies and FDA notified healthcare professionals of postmarketing reports of serious and life-threatening cardiopulmonary events following the administration of NeutroSpec [Technetium (99m Tc) fanolesomab],a radiodiagnostic agent consisting of a murine IgM monoclonal antibody formulated to be labeled with technetium,indicated for scintigraphic imaging of patients with equivocal signs and symptoms of appendicitis who are five years of age or older. Onset of these events generally occurred within minutes of injection and included two deaths attributed to cardiopulmonary failure within 30 minutes of injection.
Additional cases of serious cardiopulmonary events including cardiac arrest, hypoxia, dyspnea and hypotension required resuscitation with fluids, vasopressors, and oxygen.
Any patient who receives NeutroSpec should be closely monitored for at least one hour following product administration. Resuscitation equipment and appropriately trained personnel must be readily available during this time.
Patients with underlying cardiopulmonary conditions may be at higher risk for serious complication. NeutroSpec administration to these patients should only follow careful consideration of the known and potential risks and benefits, including the possibly higher risks.
Read the complete MedWatch 2005 Safety summary, including links to the Dear Healthcare Professional letter and current prescribing information, at:
http://www.fda.gov/medwatch/safety/2005/safety05.htm#NeutroSpec
NeutroSpec (Technetium [99m Tc] fanolesomab) 
Audience: Medical imaging specialists, hospital administrators and risk managers
[Posted 12/02/2005] Mallinckrodt, Palatin Technologies and FDA notified healthcare professionals of postmarketing reports of serious and life-threatening cardiopulmonary events following the administration of NeutroSpec [Technetium (99m Tc) fanolesomab], a radiodiagnostic agent consisting of a murine IgM monoclonal antibody formulated to be labeled with technetium, indicated for scintigraphic imaging of patients with equivocal signs and symptoms of appendicitis who are five years of age or older. Onset of these events generally occurred within minutes of injection and included two deaths attributed to cardiopulmonary failure within 30 minutes of injection. Additional cases of serious cardiopulmonary events including cardiac arrest, hypoxia, dyspnea and hypotension required resuscitation with fluids, vasopressors, and oxygen. 
Any patient who receives NeutroSpec should be closely monitored for at least one hour following product administration. Resuscitation equipment and appropriately trained personnel must be readily available during this time. Patients with underlying cardiopulmonary conditions may be at higher risk for serious complication. NeutroSpec administration to these patients should only follow careful consideration of the known and potential risks and benefits, including the possibly higher risks.

[November 30, 2005 - Letter - Mallinckrodt/Palatin] 
[July 2004 - Label - Mallinckrodt/Palatin] 
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November 30, 2005
IMPORTANT DRUG WARNING
Dear Healthcare Provider:
Mallinckrodt and Palatin Technologies Inc. are writing to inform you of postmarketing reports of serious and life-threatening cardiopulmonary events following the administration of NeutroSpec(tm) [Technetium (99m Tc) fanolesomab].

Mallinckrodt has been informed of two deaths attributed to cardiopulmonary failure within 30 minutes of injection and additional cases of serious cardiopulmonary events including cardiac arrest, hypoxia, dyspnea and hypotension. Onset of these events generally occurred within minutes of injection and required resuscitation with fluids, vasopressors, and oxygen. The majority of these reports described patients with underlying cardiopulmonary disease who received NeutroSpec(tm) for unapproved indications. However, any patient who receives NeutroSpec(tm) should be closely monitored for at least one hour following product administration. Resuscitation equipment and appropriately trained personnel must be readily available during this time. Patients with underlying cardiopulmonary conditions may be at higher risk for serious complication. NeutroSpec(tm) administration to these patients should only follow careful consideration of the known and potential risks and benefits, including the possibly higher risks. 

We are working with the Food and Drug Administration (FDA) to review these cases and revise the NeutroSpec(tm) U.S. package insert to provide additional Warnings and safety information. We intend to provide you with updated information once the review is complete.

NeutroSpec(tm) is indicated for scintigraphic imaging of patients with equivocal signs and symptoms of appendicitis who are five years of age or older. Please see the Warnings section in the enclosed NeutroSpec(tm) package insert regarding the risk for anaphylaxis and other types of hypersensitivity reactions.

For any questions, to request more information, or to report serious adverse events suspected to be associated with the use of NeutroSpec(tm), call 888-744-1414. Alternatively, adverse event information may be reported directly to the Food and Drug Administration's MedWatch Reporting System by phone at 1-800-FDA-1088, by facsimile to 1-800-FDA-0178, by mail using Form 3500 at http://www.fda.gov/medwatch/index.html.

As a reminder, a single patient dose of NeutroSpec(tm) for imaging contains 75 to 125 mcg of fanolesomab labeled with 10 to 20 mCi (370 to 740 MBq) Sodium Pertechnetate Tc 99m Injection, USP. Please refer to the enclosed PI for the current full Prescribing Information for NeutroSpec(tm).

Sincerely,

Herbert R. Neuman, MD 
Director, Global Drug Safety and Pharmacovigilance
Mallinckrodt

Sincerely,

Stephen T. Wills
Executive Vice President, Operations 
Palatin Technologies, Inc.
END

There are other producers of TECHNETIUM TC99M.
Sold on BPA and are on FSS.
James Johanson 
700 Robbins Avenue 
Bldg 6A, Station 074 
Philadelphia, PA 19111 
DSN: 444-2891 
Commercial: 215-737-2891 
Fax ext.: 3120 or 8150