Recall On Technetium

[sbrewer]

My husband had a heart stress test at the VA on Nov.15 and he received a letter from the VA

yesterday that the manufacture (Mallinckrodt Corporation) had notified them Nov. 21st that the drug

had been recalled. Well in Dec. he got a bad sinus infection(one of the side effects) and missed work

and was on antibiotics. My question Is the VA reponsible for anything, since they didn't notify him until

over 3 months later?

[Testvet]

I don't see how the VA would be liable but you may want to see if there was a class action lawsuit filed against the maker. They did notify him, because they took a couple of months would not be unreasonable, it took the VA time to find out where it went who got it, I presume he had the procedure before the recall was enacted? If not and they used it on him after the recall then they would be negligent, but at that point they could not exactly call it back, that's kind of like once the trigger is pulled, it's going to run it's course. Manufacturer liable yes, VA no thats how I see it

[Guest Berta]

I agree with you Mike- the VA acted as promptly as they could -I am sure-

if you sign up at this web site they send emails on all Class Action and recent suit filings as to medications:

http://www.lawyersandsettlements.com/

[sbrewer]

Thanks guys for your response.

sbrewer

[sbrewer]

Here is something very interesting that happened since he got the letter. The manufacture called his

primary care dr. and asked her for his medical information, she of course could not tell them anything

and probably would not tell them anything. I guess they haven't heard of the privacy act?

[Guest jstacy]

I found this:

November 21, 2005

NOTICE TO THE NUCLEAR MEDICINE COMMUNITY

As you may know, Mallinckrodt has issued a voluntary product recall of its Ultra-TechneKow® DTE Generators due to issues arising from a routine sterility assurance process revalidation. Mallinckrodt has indicated that their generator supply will be affected for a period of four to six weeks. To date, no adverse events have been reported from these products in the field.

In the wake of this development the industry is cooperating, as appropriate, to meet the overall demand for Technetium-99m (Tc-99m) generators in North America and related patient unit doses, provided through radiopharmacy distributors, which use this critical isotope. This includes production scale up for both Tc-99m generators and Molybdenum-99, the raw material isotope. At this time, it is anticipated most of the market shortages for Tc-99m generators and Tc-99m unit doses should be met beginning Monday, November 28. Varying degrees of market shortages of Tc-99m will continue to be experienced during Thanksgiving week, although unit dose shortages should be reduced as the week progresses as additional supply of Tc-99m generators is manufactured by Bristol-Myers Squibb Medical Imaging.

The possibility exists for sporadic shortages to still occur over the next month or so, due to one company not being able to assure total supply of market demand. With only one manufacturing site, other influencing factors, such as winter weather, may affect availability of Tc-99m generators and Tc-99m unit doses.

Should there be questions related to how this dynamic and evolving situation affects your facility, please contact the appropriate company sales representative for further specifics. CORAR will provide additional information, related to market supply of Tc-99m generators and Tc-99m unit doses, as it may develop.

Thank you for your understanding and assistance.

[pipeman043]

Having had several spect tests done in the past few years this particular article from the FDA

caught my eye and may be what some are refering to:

FDA is issuing this public health advisory to inform patients and health care providers that Palatin Technologies, the manufacturer of NeutroSpec (Technetium (99m Tc) fanolesomab) is voluntarily suspending marketing of NeutroSpec effective immediately due to serious safety concerns. NeutroSpec is indicated for radiologic imaging of patients with unclear signs and symptoms of appendicitis who are five years of age and older.

FDA received reports from Palatin Technologies of 2 deaths and 15 additional life-threatening adverse events in patients receiving NeutroSpec. These events occurred within minutes of administration of NeutroSpec and included shortness of breath, low blood pressure, and cardiopulmonary arrest. Affected patients required resuscitation with intravenous fluids, blood pressure support, and oxygen. Most, but not all, of the patients who experienced these events had existing cardiac and/or pulmonary conditions that may have placed them at higher risk for these adverse events. A review of all post-marketing reports showed an additional 46 patients who experienced adverse events that were similar but less severe. 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.

The relationship between NeutroSpec and these events has not been definitively determined. However, the consistent characteristics and rapid onset of these events following NeutroSpec injection makes it likely that they were due to administration of NeutroSpec. NeutroSpec is an antibody radio-labeled with technetium-99m. There is no indication that the radiopharmaceutical component of NeutroSpec, technetium-99m, was related to occurrence of these events.

The decision to suspend marketing was based on the life-threatening nature of the events and the availability of other means to diagnose 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.

NeutroSpec was approved in June 2004 for imaging of patients with equivocal signs and symptoms of appendicitis who are five years of age or older. Market approval was based on a total of 523 subjects; and adverse events of the severity described above were not observed pre-marketing. The 17 patients who experienced the serious events received NeutroSpec to diagnose infections other than appendicitis. It is not known what, if any, risk factors might increase the likelihood of such events. The FDA will work closely with Palatin Technologies to evaluate these adverse events and their potential relationship to NeutroSpec. The FDA will notify health care providers and patients in a timely fashion as new information becomes available.

The FDA urges health care providers and patients to report adverse event information associated with this or any medical product to FDA via the MedWatch program by phone (1-800-FDA-1088), by fax (1-800-FDA-0178), or by the Internet at http://www.fda.gov/medwatch/index.html.