Pharmacy & Therapeutics - May 2008 - (Page 267) NEW DRUGS even after therapy with antiestrogen drugs such as tamoxifen (Nolvadex, AstraZeneca). Elevated estrogen levels, which can lead to the initial development of breast cancer, may have contributed to the increased risk of recurrence. Women who have already been treated for breast cancer are usually advised to try to lower estrogen by exercising and keeping their weight down. Drugs like tamoxifen might not completely eliminate the hormone’s effect in women with high estrogen levels. (Sources: American Association for Cancer Research; Cancer Epidemiol Biomarkers Prevention, March 2008; www. physorg.com.) DRUG NEWS Journal, March 19, April 18, 2008; HealthDay News, March 6, 2008.) Heparin Imports Halted; Contaminant Identified Health authorities in the U.S. have ordered a halt to all imported heparin anticoagulants to test them for contaminants possibly linked to dozens of deaths and hundreds of severe allergic re actions. On March 5, the FDA said it had detected a contaminant in heparin injections sold by Baxter Pharmaceuticals. Most of the active ingredients came from China, which has been supplying heparin raw materials to the U.S. for more than a decade. As of April 29, 81 deaths had been reported. The contaminant—identified as oversulfated chondroitin sulfate—seems to have been deliberately altered chemically to mimic heparin. Chondroitin sulfate is widely sold as a dietary supplement to treat pain. The over-sulfated version does not occur in nature and was probably chemically modified. The FDA now considers that the product was deliberately altered for economic reasons. Baxter, which made about half of all the heparin used in the U.S., recalled all of its heparin products in Februar y. There is no shortage, though; another company, APP, has increased production, and no contaminants have been noted in its heparin products. Although the Chinese plant agreed not to export heparin products to the U.S., the FDA issued the alert to detain all heparin products that the plant might ship in the future. China’s drug safety agency has agreed to require stricter controls for heparin production. Earlier it said that ensuring quality was up to importers and the importing countries. Companies that have recalled heparin products made with Chinese ingredients also include Covidien (Tyco) and B. Braun. Similar recalls have occurred in Europe and Japan. (Sources: The New York Times, April 8, 2008; March 21, 2008; The Wall Street Antithrombotic Therapy And Acute Coronary Syndrome Triple anticoagulation with aspirin, clopidogrel (Plavix), and anticoagulant therapy can be an unattractive option for many clinicians, according to a multicenter study, and it’s apparently one of the reasons why hospital discharge strategies vary widely for patients with acute coronary syndrome (ACS). Researchers analyzed data from 5,673 patients enrolled in the CRUSADE trial (Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the ACC/AHA Guidelines?). They found that 25% of patients hospitalized for ACS were discharged without a prescription for continuing warfarin (Coumadin, Bristol-Myers Squibb). The perceived risk of bleeding appeared to be the overriding factor in the clinicians’ decisions to not use a triple-anticoagulant therapy, even though thrombosis-related events are possible. Women, patients with a history of coronary artery bypass grafting or heart failure, and those with higher hematocrit levels at hospital admission were more likely to be prescribed continuing warfarin therapy at discharge. Clinicians also tended not to add warfarin later, after they had made their decision, based on risks and benefits, particularly if they anticipated a long course of dual antiplatelet therapy. (Source: Am Heart J 2008;155:361– 368.) Breast Cancer and Overweight Overweight women with breast cancer seem to have more aggressive disease and lower survival. Scientists think that fat tissue may increase inflammation. In a study of 606 women with locally advanced breast cancer, at five years, overall survival rates were 56.8% in obese women, 56.3% in overweight women, and 67.4% in normal-weight women. Ten-year sur vival rates were 42.7% in obese women, 41.8% in overweight women, and 56.5% in normal-weight women. Rates of inflammatory breast cancer were 45% in obese women, 30% in overweight women, and 15% in normal-weight women. By five years, 50.8% of obese women had a recurrence, compared with 38.5% of normal-weight women. By 10 years, recurrence rates were 58% in obese women and 45.4% in normal-weight women. Drugs used after chemotherapy, such as tamoxifen (Nolvadex, AstraZeneca), may increase weight gain during treatment. Following resolution of nausea, patients may overeat, or they might have decreased their exercise during treatment; this can also lead to weight gain. (Source: Clin Cancer Res 2008;14: 1718–1725.) Do Cardiovascular Drugs Hurt or Help Cocaine Users? Emergency physicians who see young patients with symptoms of a heart attack should ask them whether they have recently used cocaine. Symptoms of a heart Vol. 33 No. 5 • May 2008 • P&T® 267 http://www.physorg.com http://www.physorg.com
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