NeutroSpec Linked To Life Threatening Side Effects

The FDA issued a public health advisory in December 2005, stating that NeutroSpec, an imaging agent used to diagnose appendicitis, had been linked to 2 deaths and 15 life threatening adverse reactions. The drug was removed from the market after 11,000 patients had been treated with it.

What is NeutroSpec?

NeutroSpec is an imaging agent used to diagnose appendicitis in patients five years of age or older with potential signs and symptoms of appendicitis as well as bone infections. It allows physicians to see clearly the "function" of the appendix rather than just the anatomy of it. NeutroSpec attaches to the white blood cells at the site of the infected appendix, "lighting up" the infection at its source. NeutroSpec is "radio-labeled" because it carries technetium, a radioactive substance. When injected into the blood, NeutroSpec finds and binds to a certain receptor on white blood cells that the body uses to fight infection. Doctors can then locate the antibody and the infection site by using a device called a gamma camera. In case of hard to diagnose cases, the gamma camera pictures allow doctors to accurately see if the appendix is infected and permits them to treat the cause appropriately.

NeutroSpec in the News

Palatin Technologies Inc. (PTN) and a unit of Tyco International Ltd. (TYC) revealed a potential risk of using Palatin's diagnostic product based on reports that several patients with severe heart problems had experienced fatal reactions to the product. The companies said the 2 deaths occurred within 30 minutes of injecting the agent. There were 15 other life-threatening adverse reactions in patients who received an injection of NeutroSpec. Within minutes patients experienced shortness of breath, low blood pressure and cardiopulmonary arrest and had to be resuscitated with fluids, vasopressors and oxygen. The majority of incidents involved patients with cardiopulmonary disease who received NeutroSpec for unapproved applications.

What is appendicitis?

Appendicitis is inflammation of the appendix. It is thought that appendicitis begins when the opening from the appendix into the cecum becomes blocked. Bacteria which normally are found within the appendix then begin to invade (infect) the wall of the appendix. The body responds to the invasion by mounting an attack on the bacteria, an attack called inflammation. If the inflammation and infection spread through the wall of the appendix, the appendix can rupture. After rupture, infection can spread throughout the abdomen.

It can be difficult to diagnose appendicitis. About half of the 700,000 annual cases of suspected appendicitis in the United States lack the usual symptoms - pain in the lower right abdomen, fever and a rising white blood cell count.

Symptoms of appendicitis may include:

• pain in the abdomen, first around the belly button, then moving to the lower right area
• loss of appetite
• nausea
• vomiting
• constipation or diarrhea
• inability to pass gas
• low fever that begins after other symptoms
• abdominal swelling

Note - Do not change medications without first consulting your doctor.