Posted by James
Manufacturer: Omrix Biopharmaceuticals Ltd., Oak
Island, NC
Indications: Used topically, Evithrom is a blood-clotting protein that aids hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and when control of bleeding by standard surgical techniques is ineffective or impractical. It may be used in conjunction with an absorbable gelatin sponge.
Drug Class: Human thrombin is derived from human plasma obtained from carefully screened and tested U.S. donors. The product has undergone steps to reduce the risk for transfusion-transmitted diseases.
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Posted by James
Manufacturer: TopoTarget A/S, Copenhagen, Denmark
Indication: Totect is used to treat extravasation resulting from IV anthracycline agents used in chemotherapy. Anthra-cyclines (e.g., daunorubicin, doxorubicin, and epirubicin) constitute one of the cornerstones in the treatment of breast cancer and leukemia. Extravasation occurs when injected drugs leak out of the vein and into the skin.
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Posted by James
Amlodipine/Olmesartan Medoxomil (Azor)
Manufacturer: Daiichi Sankyo, Parsippany, NJ
Indication: Amlodipine medication besylate plus olmesartan medoxomil is indicated for the treatment of hypertension, alone or with other antihypertensive agents. It is not indicated for the initial therapy of hypertension.
Drug Class: This product combines the complementary actions of the calcium-channel blocker generic amlodipine, which inhibits the entrance of calcium into the blood vessel walls, and of those of olmesartan, which blocks angiotensin II receptors. Angiotensin II is a hormone that causes blood vessels to constrict.
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Posted by James
Given the failure of Congress to appropriate adequate funds for drug safety, no one expects future FDA appropriations to add congressional money to the user fees that will be available for the database. That is why the agency hopes to also supplement user fees with funding provided by the Reagan-Udall Foundation, also being established by the FDAAA. The fund has a much broader purpose, however. It is a private foundation, modeled on the ones already used by the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH). The fund will raise its own operating budget. That money will be spent on collaborative research in which drug companies, academic centers, and others join together for research that would be dispersed broadly and whose results generally would not be patented. The kinds of research projects to be undertaken would be those on the FDA’s Critical Path Initiative (CPI) list.
The FDA established the CPI in March 2004. The CPI list includes 76 projects, but the FDA has funded only half a dozen or so. These projects cover biomarkers, animal models, inter-individual variability in drug response, data analysis technology and methodology in drug development, and improvements in designing and conducting clinical trials.
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Posted by James
Dolly A. Judge, Pfizer Vice President of Federal Government Relations, says:
I think more interactions are better for drug safety management purposes. But I know the optics of the industry and agency meeting more frequently is not necessarily better politically. Senator Grassley and others have been critical of the relationship between industry and FDA, so more meetings could further enhance a false perception that the relationship is too close or somehow it is unholy, so to speak.
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Posted by James
Avandia drug, the type-2 diabetes drug manufactured by Glaxo-SmithKline, is the most recent poster child for drug safety hysteria. A meta-analysis published last May by a noted cardiologist fueled concern and headlines over possible cardiovascular side effects from the drug (rosiglitazone maleate), forcing the FDA to revisit Avandia’s labeling in the absence of any new, convincing clinical trials. The result: GSK’s agreement in mid-November to expand Avandia’s existing black-box warning with confusing language saying “a risk of an increase in myocardial ischemic events was not confirmed or excluded in three long-term clinical trials.”
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Posted by James
The major aim of this study was to assess the outcome of severe hyponatremia and characterize factors influencing outcome in hospitalized patients with this disorder. This study suggests that severe hyponatremia is associated with high mortality. It is unclear if this association derives from hyponatremia per se, or the associated comorbidity in these subjects.
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