The U.S. Food and Drug Administration has temporarily halted the use of the drug Trasylol, which is used to control bleeding during heart surgery.
The FDA said it asked the drug's manufacturer -- the Bayer Pharmaceuticals Corp. of Germany -- to withdraw Trasylol from the U.S. market pending a review of a study at Canada's Ottawa Health Research Institute that suggested the drug might result in an increased death rates.
FDA officials said until the study is reviewed, it is not possible to determine and identify the population of patients undergoing cardiac surgery for which the benefits of Trasylol might outweigh the risks.
Two weeks ago, the FDA was notified the Canadian institute had halted a Trasylol study because the drug appeared to increase the risk of death compared with two other antifibrinolytic drugs used in the study. However the preliminary data from the terminated study also suggested the drug was effective in reducing serious bleeding events during surgical procedures.
Copyright 2007 by United Press International
Related stories:
Study confirms cardiac surgery drug increases death rate
The largest study to date of a controversial cardiac surgery drug shows it increases death rates and damages kidney function, according Duke University Medical Center researchers.
Limit on cold remedies for kids was FDA's idea
(AP) -- When drug makers made a surprise announcement this week that they no longer recommend cough and cold remedies for youngsters under 4, they didn't let on that it was the government's idea.
Want a mammogram? Get in line
Doctors usually recommend that women older than 40 get yearly mammograms. But if you're planning on calling Northwestern Memorial Hospital's state-of-the-art breast imaging center, grab next year's calendar: The next opening is in May.
Older renal cancer patients appear to benefit from sorafenib treatment
Older and younger patients with renal cancer derive similar benefit from sorafenib therapy and tolerate the drug equally well, according to a study published online October 7 in the
Journal of the National Cancer Institute.
Vietnam finds tainted products from China
(AP) -- Vietnam's health ministry has discovered the industrial chemical melamine in 18 food products imported from China and three other countries and has ordered them recalled and destroyed, officials said Friday.
FDA: No quick decision on cold medicines for kids
(AP) -- A top government health official rejected the idea of an immediate ban on cough and cold medicines for young children, saying it might cause unintended harm.
Nanodiamond drug device could transform cancer treatment
A Northwestern University research team has developed a promising nanomaterial-based biomedical device that could be used to deliver chemotherapy drugs locally to sites where cancerous tumors have been surgically removed.
FDA urged to recall cold medicines for youngsters
(AP) -- With a new cold season coming, the government is trying once more to decide what to do about over-the-counter medicines for kids' coughs and sniffles. Doctors question the drugs' benefits and worry about their risks.