Navigation Links
Hemophilia Drug Used Off-Label Raises Clot Risk
Date:11/4/2010

By Jenifer Goodwin
HealthDay Reporter

WEDNESDAY, Nov. 3 (HealthDay News) -- A drug approved to help staunch bleeding in people with hemophilia raises the risk of heart attacks and stroke when it's used to stop life-threatening bleeding due to other conditions, such as trauma or surgery, a new study finds.

Despite the nearly twofold rise in risk of dangerous clots that form inside blood vessels and cause heart attacks and stroke in those without hemophilia, researchers said doctors should use the information to carefully weigh the risks and benefits of using the drug, called recombinant activated factor VII (rFVIIa), for any "off-label" use.

"If you are a physician confronted with a patient with excessive blood loss, and you have done everything you can and this patient is almost dying because of the bleeding, it's quite acceptable to give the drug even if it's associated with a risk of thrombosis [clotting]," said study author Dr. Marcel Levi, a professor of Medicine at University of Amsterdam in the Netherlands. "On the other hand, if you are confronted with a patient who has less than excessive blood loss and you can try other things, then the twofold increased risk of thrombosis is considerable and I would not give the drug."

The study is published in the Nov. 4 issue of the New England Journal of Medicine.

What makes the study so unusual is that the drug maker, Novo Nordisk, gave researchers access to unpublished data on the drug and its potential side effects, said Dr. Louis Aledort, a professor of medicine at Mount Sinai School of Medicine in New York City, who wrote an accompanying editorial.

"The company is to be congratulated," Aledort said. "It would be really great if other companies would do the same so that clinicians thinking about using it a drug in an off-label setting would have all the information at hand so they could make the right decision, which is benefit vs. risk."

rFVIIa was approved about 10 years ago by the U.S. Food and Drug Administration for use in people with hemophilia. Hemophilia is a group of blood disorders in which the blood doesn't clot properly, raising the risk of prolonged bleeding, internal bleeding and bleeding into the joints.

Increasingly, the drug has also been used for so-called "off-label" use, or to treat conditions not expressly licensed by the FDA, Aledort said. While it is legal for physicians to use a drug in this way, a drug's maker cannot promote its use for anything but the condition for which it is approved.

Such "off-label" uses include stopping brain bleeds and staunching bleeding during surgery due to trauma or advanced liver disease, according to the study.

Despite it's effectiveness in stopping bleeding and promoting beneficial clotting, there have been reports of complications, including heart attacks and stroke.

In the study, researchers looked at 35 published and unpublished studies on off-label usage of rFVIIa to treat or prevent bleeding. The studies involved more than 4,100 people who experienced excessive bleeding, some of whom were given rFVIIa and some who weren't. Overall, about 11 percent experienced arterial thrombosis, most often a heart attack, unstable angina (a precursor to a heart attack) or stroke.

About 5.5 percent of those who received rFVIIa experienced arterial thrombosis, compared to 3.2 percent of those who were given a placebo.

About 2.9 percent of those who received rFVIIa had a heart attack compared to about 1.1 percent given a placebo.

The risk of dangerous clots rose with age. Among those 65 and older, 9 percent of those given rFVIIa experienced arterial thrombosis compared to 3.8 percent given a placebo. For those 75 and up, rates rose to 10.8 percent and 4.1 percent, respectively.

There was no increased risk of venous thrombosis, such as clots in the legs or lungs (pulmonary embolism).

"The company helped us. They opened their files. They showed us unpublished data on complications. It's exemplary that the company did this," Levi said. "Usually companies keep that information a little bit obscure."

Aledort said this type of research should serve as a template for the rest of the pharmaceutical industry to follow. "It was very brave of the company," he said.

More information

The American Heart Association has more on heart attacks.

SOURCES: Marcel Levi, M.D., professor, medicine, Academic Medical Center, University of Amsterdam, The Netherlands; Louis Aledort, M.D., professor, medicine, Mount Sinai School of Medicine, New YorkCity, Nov. 4, 2010, New England Journal of Medicine


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Pfizer Hemophilia presents new data at the World Federation of Hemophilia 2010 Congress
2. Study raises concern about ability of tests to predict fertility
3. Web Connection Raises Chances of Romance
4. Spread of Whooping Cough Raises Concern
5. Avandia Raises Heart Risk But Should Stay on Market, FDA Panel Finds
6. Hormone Raises Desire for Fattening Foods
7. Pro Ana Versus Pro Recovery Sites: New Study by Johns Hopkins and Stanford University raises concerns.
8. Apptera Raises $10M to Grow Its Voice And Visual Mobile Ad Network
9. Department of Labor Raises the Bar
10. AFOP's Children in the Fields Campaign Raises Awareness of Child Labor in the U.S.
11. Low IQ Among Males Raises Suicide Risk
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Hemophilia Drug Used Off-Label Raises Clot Risk
(Date:2/8/2016)... CA (PRWEB) , ... February 08, 2016 , ... Delta ... $792,000 to help combat pancreatic cancer. , Gary D. Radine, who recently retired as ... was the American Cancer Society’s 2015 CEO of the Year , helped lead ...
(Date:2/8/2016)... (PRWEB) , ... February 08, 2016 , ... Discover the ... visit over 1,400 booths and 700 companies. Attendees also get to see the ... Colorado Garden & Home Show , at the Colorado Convention Center - 700 ...
(Date:2/8/2016)... ... 08, 2016 , ... Guruji Mahendra Kumar Trivedi is offering 3 days of ... of his birthday on February 10th. During this time, people can achieve better ... over 250,000 people from over 40 different countries as an “ordinary man with an ...
(Date:2/7/2016)... ... February 07, 2016 , ... HealthSmart Holdings, Inc. announced ... with the tools and information to lower the costs, and increase the impact ... of providing employee healthcare benefits by as much as 22%:, + Price ...
(Date:2/6/2016)... ... 06, 2016 , ... Shark Finds and Kevin Harrington, along with ... DRTV campaign with Belly Bands. , Having a dog is great—except when it wets ... and find nothing works, get Belly Bands, the easiest way to stop dogs ...
Breaking Medicine News(10 mins):
(Date:2/5/2016)... 5, 2016 Amgen (NASDAQ: AMGN ) will ... Healthcare Conference at 9:15 a.m. ET on Wednesday, Feb. 10, ... David W. Meline , executive vice president and chief financial ... of the presentation can be accessed from the Events Calendar ... of the webcast will also be available on Amgen,s website ...
(Date:2/5/2016)... , Feb. 5, 2016  As people age, it ... multitude of recommended screenings and tests that are linked ... priority. However, for the majority of aging individuals, hearing ... planning. For the 37.5 million American adults who report ... present to make hearing health a 2016 healthy aging ...
(Date:2/5/2016)... , Feb. 5, 2016 Aethlon Medical, Inc. (Nasdaq: ... Chairman and CEO, will be presenting at Source Capital Group,s ... York, NY at 2:15 p.m. ET on Wednesday, ... Immunotherapy Panel discussion taking place at 3:15 p.m. ET. ... approximately one hour after the conclusion of the live event. ...
Breaking Medicine Technology: