FDA approves Evicel Fibrin surgical sealant

TheU.S. Food and Drug Administration (FDA) has approved Evicel Fibrin Sealant, a liquid product that when applied topically helps control oozing from small blood vessels during surgical procedures.

"Evicel provides an effective means to stop oozing from small vessels during vascular surgery when suturing, compression or other standard techniques are not effective or practical," said Jesse Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research.

This product is derived from pooled human plasma and consists of a fibrinogen concentrate and thrombin, two substances used to promote clotting. Both substances go through a two-stage process to reduce the risk of viral transmission in manufacturing, however, the potential risk for the transmission of blood-borne viruses cannot be totally eliminated.

In a pivotal study of 147 patients, the effectiveness of Evicel was compared with the standard bleeding control technique of applying pressure to a plastic covering (graft) placed over the open blood vessel. Eighty-three percent of those who received Evicel stopped bleeding within four minutes, compared with 39.7 percent in the control group.

Adverse events, such as anemia and graft site infection, were generally mild and occurred at about the same frequencies in the Evicel-treated group and the control group.

FDA originally licensed the predecessor of Evicel (Crosseal) in 2003 for use during liver surgery. Evicel is manufactured by OMRIX biopharmaceuticals LTD, Kiryat Ono, Israel.

802 haemophilia patients at risk from vCJD

Figures released by the Department of Health state that 802 haemophiliacs received blood from patients who went on to develop variant Creutzfeldt-Jackob Disease (vCJD).

It comes after a haemophiliac in his 70s was found to be infected with vCJD after his death. Although the infection was not the cause of his death, he had been treated with blood from a donor who later died from vCJD.

The disease, which destroyed Britain's beef industry in the mid 1990s, is believed to have been responsible for an estimated 164 deaths since 1995.

The Haemophilia Society has now called on the Government to test the patients at risk as soon as possible to determine whether they had contracted the disease.

Health officials released the figures in response to calls from Lord Morris of Manchester, who demanded to know whether the Government had revised its assessment of the risk presented by contaminated blood following the death of the haemophiliac who was found to be infected with vCJD.

Lord Darzi, Labour's health minister in the Lords, stated in a written answer to Lord Morris: "To date, 802 haemophilia patients are registered on the UK Haemophilia Centre Doctors' Organisation database as receiving clotting factors made from UK plasma pools containing a donation from a donor who went on to develop vCJD."

The Department of Health also revealed that 66 people who are not haemophiliacs have received blood components from donors who later went onto develop vCJD. Of these, 22 are still living, three died after contracting vCJD, and the others died from unrelated causes.

Chris James, chief executive of the Haemophilia Society, said: "We now know a much larger number of people have been exposed to higher-risk blood and blood product than was previously thought. vCJD remains an illness for which there is no test and no cure.

"It is just the latest in an increasingly long line of infections that people affected by bleeding disorders have been exposed to."

Haemophilia is a blood condition in which an essential clotting factor is missing and sufferers bleed for longer than normal. Around 6,000 people are affected by the condition within the UK.

Almost 4,700 haemophilia patients were infected with hepatitis C after receiving contaminated blood products that were given during the 1970s and 1980s. Campaigners have been fighting for compensation from the Government over the scandal.

The brain-wasting disease vCJD was first detected in the mid 1990s and since then most vCJD patients are thought to have been infected after eating BSE-contaminated meat.

The number of vCJD deaths peaked in 2000, when there were 28. That number has dropped to about five a year since 2005.

The epidemic of BSE in the 1980s and 1990s was caused by cattle being fed the remains of other cattle in the form of meat and bone meal, causing an infectious agent to spread.

More than four million cattle were slaughtered after almost 200,000 were infected with the fatal neurodegenerative disease.

Scientists recently warned that Britain could see a second wave of vCJD, affecting as many as 300 people, after discovering that genetic differences can affect how long it takes a person to incubate the disease.