Leukemia drug Mylotarg taken off the market over safety, effectiveness concerns

For patients with a diagnosis of the blood cancer acute myeloid leukemia, or AML, the search for a drug that can effectively treat a recurrence of leukemia has been elusive. So the withdrawal from the market Monday of the AML drug gemtuzumab ozogamicin, marketed as Mylotarg, comes as another disappointment to those hoping for a cure.

Pfizer, which makes Mylotarg, withdrew the drug after a clinical trial raised concerns about its safety and effectiveness. Early trials had spurred hopes that Mylotarg would induce remission -- meaning the absence of leukemia in the bone marrow -- in almost a third of patients who took it. But the drug, which promised reduced side effects because it appeared to home in only on cancerous cells, has been associated with a serious and sometimes fatal liver condition call veno-occlusive disease.

Although Mylotarg received accelerated FDA approval in 2000, the agency required an additional clinical trial to demonstrate its safety and effectiveness. That trial, which began in 2004, has shown higher levels of liver toxicity in patients than seen in early trials, with no benefits to patients. In fact, compared with AML patients on standard chemotherapy alone, those on Mylotarg were more likely to die.

The FDA said that patients who have begun treatment with Mylotarg may complete their therapy, but that patients with new recurrences of AML will not be permitted to start on the medication.

Remember that some patients with AML can be treated -- and cured -- with a bone marrow transplant, but they need an excellent match for a good outcome. Joining the bone marrow registry is easy and painless, and you could be the match that saves someone's life. Find out why and how to register as a prospective bone marrow donor here.

-- Melissa Healy

Mild clotting disorders may signal trouble

About one-quarter of people with mild blood clotting in vessels close to the skin may also have the potentially dangerous condition called deep vein thrombosis, according to a study published today in the Archives of Dermatology.

Superficial vein thrombosis is common and usually affects the veins in the legs. Researchers in Austria studied 46 people with superficial vein thrombosis. All of the patients underwent an imaging test to confirm superficial vein thrombosis and to exclude or detect deep vein thrombosis. Deep vein thrombosis was found in 24% of patients, most often in the calf muscles.

"Generally, superficial vein thrombosis is regarded as a condition with an uncomplicated course and usually is not considered to be a severe or life-threatening disease," the authors wrote. But, they add, deep vein thrombosis can be a serious condition. People with superficial vein thrombosis in the lower leg may need to be evaluated for deep vein thrombosis.

-- Shari Roan

Photo credit: Lori Shepler / Los Angeles Times