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FDA Approves Human Fibrinogen Concentrate for Treatment of Bleeding in Congenital Fibrinogen Deficiency
RiaSTAP, an intravenous fibrinogen concentrate made from human plasma, is indicated for patients who have no fibrinogen or low levels of fibrinogen.
News, January 2009
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FDA Continuing to Study Effectiveness of Clopidogrel
The Food and Drug Administration is continuing to study the effectiveness of clopidogrel in patients taking other medications, particularly proton-pump inhibitors, and in those with genetic variants linked with clopidogrel resistance and a subsequent increased risk of cardiovascular outcomes.
News, January 2009
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Tocilizumab Approved for Rheumatoid Arthritis in Europe
The European Commission has approved Roche's first-in-class therapeutic tocilizumab for the treatment of moderate-to-severe rheumatoid arthritis. Efforts are underway to meet FDA requirements for US approval.
News, January 2009
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FDA Expands List of Tainted Weight-Loss Products
The expanded list ups the number of contaminated products from 28 to 69. Many of these "natural" or "herbal" products contained sibutramine, phenolphthalein, and even rimonabant.
News, January 2009
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FDA MedWatch Issues Alert on Safety of Topical Anesthetics
The FDA today released a public-health advisory to underline the potential risks associated with overuse of topical anesthetics. In particular, women undergoing mammography or others using the agents over large areas of the body may be at risk.
News, January 2009
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FDA Approves Milnacipran for Fibromyalgia
Forest Laboratories and Cypress Bioscience announced that the FDA has approved milnacipran, a dual serotonin- and norepinephrine-reuptake inhibitor, for the management of fibromyalgia.
News, January 2009
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FDA Continues to Review Link Between Montelukast and Neuropsychiatric Effects
The FDA advises healthcare professionals to monitor patients taking drugs that work through the leukotriene pathway for suicidality and changes in behavior and mood.
News, January 2009
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FDA Supports Use of Vytorin, Completes Year-Long Review of ENHANCE
Low LDL-cholesterol levels remain the optimal treatment target, and pending the results from IMPROVE-IT, patients should not stop taking Vytorin or other cholesterol-lowering medications, according to the FDA.
News, January 2009
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FDA Approves Tramadol Extended-Release Formulation for Chronic Pain
Labopharm, Inc announced the FDA has approved a once-daily extended release formulation of tramadol (Ryzolt) for the management of moderate to moderately severe chronic pain.
News, January 2009
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FDA Approves First Nucleic Acid Test to Screen for 2 Divergent HIV Types
The US Food and Drug Administration has approved the cobas TaqScreen MPX test for the presence of 2 divergent types of HIV in donated blood plasma and tissue.
News, January 2009
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FDA Warns That Tinzaparin Increases Mortality Risk in Elderly Patients With Renal Insufficiency
A clinical study indicated that tinzaparin may lead to an increased risk for death in all renal-impaired elderly patients receiving tinzaparin.
News, January 2009
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Recall Issued for Stryker Custom Cranial Implant Kits
The FDA has issued a class 1 recall for the custom cranial implant kits because of lack of assurance of sterility and risk for infection.
News, December 2008
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FDA Approves Gleevec for Gastrointestinal Stromal Tumor
The FDA has approved imatinib mesylate to prevent postoperative recurrence of gastrointestinal stromal tumor.
News, December 2008
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FDA Requires Warnings About Suicidality Risk With Antiepileptic Drugs
The US Food and Drug Administration will require the manufacturers of antiepileptic drugs to add a warning to their labeling that use of the drugs increases risk for suicidal thoughts and behaviors.
News, December 2008
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FDA Approves Plerixafor to Improve Stem Cell Mobilization for Autologous Transplantation
The CXCR4 chemokine antagonist is thought to enhance mobilization of stem cells for autologous transplantation in patients with non-Hodgkin's lymphoma and multiple myeloma.
News, December 2008
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Gravity Compensating Accessory by Integra NeuroSciences Recalled
A class 1 recall of the Gravity Compensating Accessory has been announced because the device may leak cerebrospinal fluid.
News, December 2008
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Oral Sodium Phosphate Products Linked to Acute Phosphate Nephropathy
The use of oral sodium phosphate products has been tied to acute phosphate nephropathy.
News, December 2008
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Tinzaparin Mortality Risk Not Limited to Patients Older Than 90 Years
Clinicians should consider alternatives to tinzaparin sodium when treating patients aged 70 years and older with renal insufficiency.
News, December 2008
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FDA Approves Tapentadol for Moderate to Severe Acute Pain
The FDA has approved tapentadol, an immediate-release oral tablet, for the treatment of moderate to severe acute pain.
News, November 2008
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FDA Investigates Genetic Link to Phenytoin Skin Reactions
Clinicians should avoid the antiepileptic drugs phenytoin and fosphenytoin as alternatives to carbamazepine therapy in patients positive for the HLA-B*1502 allele.
News, November 2008
