Factor VII gets new storage guidelines
The FDA approved new storage guidelines for antihemophilic factor VII [recombinant] injection (Helixate FS and Kogenate FS), allowing the medication to be stored at room temperature, 77[degrees]F or 25[degrees]C, for up to 3 months. Recombinant factor VII injection is indicated for the treatment of hemophilia.
Test data demonstrated that the labeled potency of the product remained within specified limits through the expiration date. Consequently, the new guidelines provide users with greater flexibility and simplify storage options, but refrigeration is still recommended whenever possible. Products stored at room temperature should not be returned to refrigeration.
Source: National Hemophilia Foundation. New Kongenate storage guidelines promise added convenience. Available at: http://www.hemophilia.org/NHFWeb/MainPgs/MainNHF.aspx?menuid=118&contentid=354&r. Accessed September 1, 2006.
Immunoassay helps diagnose VTE
The FDA approved a new indication for an N-terminal pro- brain natriuretic peptide (BNP) immunoassay (NT-proBNP), allowing its use as an aid in the diagnosis of venous thromboembolism (VTE).
This test was previously approved for use as an aid in the diagnosis of congestive heart failure (CHF), assessment of CHF severity, and risk stratification of patients with acute coronary syndrome and heart failure.
The test offers timely determination of NT-proBNP concentration; capability to process a full cardiac panel using one sample, one tube, and one analyzer; minimal reagent waste; no manual pretreatment of samples; and assay sensitivity.
Source: Business Wire. Research suggests that cardiac marker NT-proBNP is a better predictor for mortality than BNP in heart failure patients with reduced kidney function. Available at: http://www.findarticles.com/p/articles/mi_MOEIN/is_2005_Dec_1/ai_n15890577. Accessed September 1, 2006.
Mifepristone receives updated advisory
The FDA has been informed of two additional deaths following medical abortion with mifepristone (Mifeprex) and is investigating the circumstances associated with the cases. The agency is making all providers of medical abortions aware of the specific circumstances and directions for using this drug, and all risks, including sepsis, when considering treatment.
In particular, providers and patients should discuss early signs and symptoms that may warrant immediate medical evaluation.
The approved regimen for mifepristone for a medical abortion through 49 days' pregnancy is specified in the advisory, along with information about sepsis and its symptoms.
Source: FDA. FDA public health advisory: sepsis and medical abortion update. Available at: http://www.fda.gov/cder/drug/advisory/mifeprex200603.htm. Accessed September 1, 2006.
High-concentration topical capsaicin approved
The FDA approved orphan drug status for a high-concentration topical capsaicin product, TQ-1018, in the management of postherpetic neuralgia. The medication is applied in conjunction with a local topical anesthetic, to provide pain relief that lasts from weeks to months.
Source: TheraQuest Biosciences. TheraQuest receives 7-year market exclusivity for topical capsaicin. Available at: http://www.theraquestinc.com/news/pressrelease/pr_06_1_30.htm. Accessed September 1, 2006.
New benefits for post-PCI abciximab
Researchers have successfully treated non-ST-segment elevation acute coronary syndrome (ACS) patients with the drug abciximab for preventing ischemic complications following percutaneous coronary intervention (PCI). While pretreatment with clopidogrel has been considered prevention enough for stable coronary disease patients, ACS patients benefit from a stronger approach to antiplatelet therapy. In an international, multicenter, randomized double-blind placebo-controlled study, non-ST-segment elevation ACS patients, over half with complex lesions and high troponin levels, were pretreated with clopidogrel and aspirin at least 2 hours before undergoing PCI. Following the procedure, researchers randomized 1,012 patients to receive abciximab plus heparin and 1,010 to receive placebo plus heparin. By 30 days, death, myocardial infarction, or urgent target vessel revascularization had occurred for 8.9% of abciximab patients and 11.9% of the controls. Although eight patients in the abciximab group experienced a severe decrease in platelet count, abciximab generally improved outcomes for patients with elevated troponin levels.
Source: Kastrati A, et al. Abciximab in patients with acute coronary syndromes undergoing percutaneous coronary intervention after clopidogrel pretreatment. JAMA. 2006;295:1531-1538.