Bayer drug unproven as stroke preventer: US
September 6, 2011 in MedicationsUS regulators said Tuesday that Xarelto, a Bayer-made drug approved in July for preventing blood clots, is so far unproven for a new proposed use as a stroke preventer.
"There is a lack of substantial evidence that rivaroxaban will have its desired effect when used as recommended in labeling," said documents released by the US Food and Drug Administration.
An advisory committee to the FDA would further discuss the latest findings on Thursday.
"This review posted today has to do with the application for the new use and at this point does not impact the already-approved use," said FDA spokeswoman Sandy Walsh.
Xarelto is currently on the market to reduce the risk of blood clots, deep vein thrombosis, and pulmonary embolism following knee or hip replacement surgery.
Bayer's stock plunged nearly 12 percent by midday in US trading.
(c) 2011 AFP
-
J&J wins US approval for new blood thinner
Jul 02, 2011 |
not rated yet |
0
-
New warning OK'd for birth control patch
Jan 21, 2008 |
not rated yet |
0
-
New no-needle approach to prevent blood clots
Aug 11, 2009 |
not rated yet |
0
-
International research team reports major findings in prevention and treatment of blood clots
Jan 11, 2011 |
not rated yet |
0
-
FDA approves warfarin labeling change
Aug 16, 2007 |
not rated yet |
0
-
Of mice and mental models: Neuroscientific implications of risk-optimized behavior in the mouse
18 hours ago |
not rated yet |
0
-
Limits to growth: Scientists identify key metastasis-enabling enzyme
May 22, 2012 |
5 / 5 (4) |
0
-
Seeing is as seeing does: Spatially-structured retinal input in early development of cortical maps
Apr 26, 2012 |
5 / 5 (4) |
1
-
Dreamless nights: Brain activity during nonrapid eye movement sleep
Apr 09, 2012 |
4.4 / 5 (12) |
0
-
Take your time: Neurobiology sheds light on the superiority of spaced vs. massed learning
Mar 28, 2012 |
4.5 / 5 (21) |
3
-
A question about drug tolerance
May 23, 2012
-
Poor nutrition leading to overeating?
May 23, 2012
-
Math and dyslexia?
May 21, 2012
-
portable metabolism meter?
May 21, 2012
-
Rare medical conditions on 20/20 tonight
May 18, 2012
-
"Good" Cholesterol in Doubt
May 17, 2012
- More from Physics Forums - Medical Sciences
More news stories
Missouri opts for untested drug for executions
(AP) -- The same anesthetic that caused the overdose death of pop star Michael Jackson is now the drug of choice for executions in Missouri, causing a stir among critics who question how the state can guarantee ...
Medications
May 24, 2012 |
not rated yet |
4
Aspirin may prevent recurrence of deep vein blood clots
(HealthDay) -- After suffering a type of blood clot called a venous thromboembolism, patients usually take a blood-thinner such as warfarin (Coumadin). But aspirin may do just as well after a period of time, ...
Medications
May 23, 2012 |
not rated yet |
2
|
Patients may receive too much acetaminophen in hospital
(HealthDay) -- Roughly 2.5 percent of admitted hospital patients may receive more than the safe daily cumulative dose of the pain-reliever acetaminophen, best known as Tylenol, on at least one day, according ...
Medications
May 23, 2012 |
1 / 5 (1) |
0
New quality standards limiting elemental impurities in medicines announced
As part of its ongoing efforts to help ensure the quality of medicines, the U.S. Pharmacopeial Convention (USP) has announced two new standards related to elemental impurities: General Chapters Elemental Impurities—Limits and ...
Medications
May 23, 2012 |
not rated yet |
0
Quality standards for heparin further strengthened
To help further secure a safe supply of the widely–used blood thinner heparin, a third round of revisions to quality standards for the drug has been advanced by the U.S. Pharmacopeial Convention (USP). USP's Expert Panel ...
Medications
May 23, 2012 |
not rated yet |
0
Of mice and mental models: Neuroscientific implications of risk-optimized behavior in the mouse
(Medical Xpress) -- Regardless of an organism’s biological complexity, every encephalized animal continuously makes under-informed behavioral choices that can have serious consequences. Despite its ubiquity, ...
Tongue analysis software uses ancient Chinese medicine to warn of disease
For 5,000 years, the Chinese have used a system of medicine based on the flow and balance of positive and negative energies in the body. In this system, the appearance of the tongue is one of the measures used to classify ...
Cancer may require simpler genetic mutations than previously thought
Chromosomal deletions in DNA often involve just one of two gene copies inherited from either parent. But scientists haven't known how a deletion in one gene from one parent, called a "hemizygous" deletion, can contribute ...
Inherited DNA change explains overactive leukemia gene
A small inherited change in DNA is largely responsible for overactivating a gene linked to poor treatment response in people with acute leukemia.
Skp2 activates cancer-promoting, glucose-processing Akt
HER2 and its epidermal growth factor receptor cousins mobilize a specialized protein to activate a major player in cancer development and sugar metabolism, scientists report in the May 25 issue of Cell.
Early physical therapist treatment associated with reduced risk of healthcare utilization and reduced overall healthcare
A new study published in Spine shows that early treatment by a physical therapist for low back pain (LBP), as compared to delayed treatment, was associated with reduced risk of subsequent healthcare utilization and lower ...
