Parker Waichman LLP

NeutroSpec Public Health Advisory

  NeutroSpec Life-Threatening Adverse Events. The Food and Drug Administration (FDA) today issued a Public Health Advisory to alert health care providers that the agency has requested the market withdrawal of the diagnostic imaging agent NeutroSpec pending review of reported deaths and serious and life-threatening adverse events associated with use of the product. The manufacturer, […]

Advisory on use of NeutroSpec

 

NeutroSpec Life-Threatening Adverse Events. The Food and Drug Administration (FDA) today issued a Public Health Advisory to alert health care providers that the agency has requested the market withdrawal of the diagnostic imaging agent NeutroSpec pending review of reported deaths and serious and life-threatening adverse events associated with use of the product.

The manufacturer, Palatin Technologies Inc. and marketing partner, Mallinckrodt, have agreed to implement an immediate voluntary market suspension making the product unavailable for approved or investigational uses.

The adverse event reports submitted to FDA as part of the Agency’s routine postmarket surveillance of all medical products revealed cases where NeutroSpec caused allergic type (hypersensitivity) reactions that occurred within minutes following NeutroSpec administration. These reactions led to the death of two patients, and to cardiopulmonary failure, central nervous system reactions, and infusion reactions in other patients.

In pre-market studies submitted to the Agency as part of the drug’s application for approval, NeutroSpec was administered to 523 patients. These studies revealed relatively few safety concerns. Most of the adverse events occurred in patients who were given the drug post-approval on an off-label basis. All of the reactions occurred immediately after NeutroSpec was administered. There is no evidence that patients who already safely received the drug face any long-term risk.

Life-threatening Nature

NeutroSpec, approved for marketing in July 2004, is a diagnostic imaging agent that is administered intravenously to help diagnose appendicitis in patients five years and older with possible appendicitis who lack its conventional signs and symptoms. FDA said the decision to suspend marketing was based on the life-threatening nature of the associated adverse events, the unpredictability of the reaction, and availability of other means of diagnosing appendicitis that do not carry these risks.

FDA urges health care providers to discontinue use of existing stocks of NeutroSpec and to contact Palatin Technologies regarding their return. FDA is conducting further investigation into the deaths and adverse events associated with NeutroSpec. The Agency is working closely with the manufacturers of the product to evaluate the risks and benefits associated with its use.

FDA also plans to convene an advisory committee meeting in early 2006 to discuss the existing data about the risks and benefits of NeutroSpec, what additional safety measures can be taken with its use, and what indications may exist where benefits of the product are outweighed by the known risks. The FDA will notify health care providers and patients in a timely manner following further scientific investigation of adverse event reports.

Need Legal Help Regarding NeutroSpec?

The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
They were very helpful & extremely patient with my non-stop requests for clarification regarding certain things that I didn’t understand. The majority of my interactions were with Ashley & she was absolutely wonderful. She was knowledgeable, pleasant & always made it clear that I wasn’t a burden when I was asking her to once again explain something to me that she had already done at least one time in the past.
RUSSELL MAHON
4 years ago
5 Star Reviews 150
Since the start of my case with the firm. Ms. Joanne, my assigned Nurse as been making that am being treated properly in terms of my injury.
Kirk Stevens
5 years ago
5 Star Reviews 150
I was in a car accident about a month ago, and had no idea what to do or where to go for help. As I was struggling to walk one morning, when the commercial for Park Waichman came on and the jingle stuck in my head "1800 Just Call, just call that's all!" Well, I called, and like the jingle says, that's all I had to do. Everyone at the office has been a very present help, and always answer my calls and emails timely. Julie and Maryann have been so patient and wonderful with my constant questions, and have taken care of everything! Joanne has been a constant reassurance in reaching out to check on me and make sure that my medical needs are being addressed by my health care providers and that my care is progressing as best as possible. She has a very warm and kindhearted demeanor, which makes everything seem like it will be ok. Thank you for that Joanne, it means the world to me! I would highly recommend the team at Parker Waichman.
ELEONOR PAZMINO
5 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038