Pharmacy and Therapeutics - January 2008 - (Page 12) NEW DRUGS with intraventricular hemorrhage, patent ductus arteriosus (a congenital heart defect), respiratory distress syndrome, or death. Indomethacin is often used only for very early labor, but many obstetricians believe that it is more effective and has fewer side effects for the mother than other commonly used tocolytic agents; therefore, they might use it when the pregnancy is farther along. The study’s lead author, Dr. Glantz, says that these drugs are not benign; doctors must decide whether to prevent a premature birth, with the baby benefitting from more time in the womb, or running the risk of providing extra time in the womb with its associated problems. He recommends that indomethacin be prescribed only for patients who need it the most. (Source: Am J Obstet Gynecol 2007; 197[5]:486, e1–e10.) DRUG NEWS would be five additional deaths, four additional heart attacks, and three additional episodes of heart failure. The study’s conclusions are similar to those of a previous analysis from the Cleveland Clinic. In November, the FDA decided that the evidence against rosiglitazone was inconclusive but added a black-box warning to the label. GlaxoSmithKline claimed that these patients tended to be sicker with a higher risk of cardiovascular disease to begin with. (Sources: JAMA, December 11, 2007; The New York Times, December 12, 2007; GlaxoSmithKline, www. gsk.com.) Class I Recall: Ventricular Assist Device Thoratec’s Implantable Ventricular Assist Device (IVAD), catalog number 10012-2555-001 and serial numbers 488 or higher, is being recalled. The product was made and distributed from October 1, 2004, through October 22, 2007. This mechanical device is designed to provide sufficient blood flow to the damaged or diseased hear t. Sometimes called a “bridge to transplant,” the IVAD can help patients survive until a heart transplant procedure is performed. Although the current instructions state that the device may be implanted or placed in the external position, air leaks may develop in the pneumatic driveline if the IVAD is placed in this position, possibly causing insufficient blood flow to and from the heart. Thoratec notified its customers of the problem on October 19 and included new instructions for placement and care of the driveline. Doctors should contact their patients if any Thoratec IVAD was placed in the external position. The affected devices were distributed to 87 hospitals in the U.S. and other countries. (Source: FDA, October 19, 2007.) Guidelines for Off-Label Uses of Drugs The FDA has issued an internal draft guidance that would allow pharmaceutical and medical device companies to use journal articles to promote off-label uses of their products without the agency’s prior review or approval. A draft guidance describes the FDA’s opinion on a topic and makes recommendations, but it is not legally enforceable. Representative Henry A. Waxman (DCalif.), Chairman of the House Committee on Oversight and Government Reform, called the guidance “ill advised.” He was concerned that the change could improperly influence doctors’ prescribing habits and that companies would be less likely to conduct clinical trials or seek FDA approval for products. According to the draft, manufacturers could distribute reprints of peer-reviewed research from reputable medical journals as long as the articles were not written or influenced by companies or individuals with financial ties to the drug or device. (Sources: www.drugtopics.com; http:// oversight.house.gov.) FDA Questions Safety Of Cefepime (Maxipime) The FDA has requested additional data to further evaluate the risk of death in patients treated with the antibiotic cefepime (Maxipime, Bristol-Myers Squibb). A higher all-cause mortality rate has been reported in patients treated with cefepime compared with other beta lactams. Cefepime, a broad-spectrum, betalactam cephalosporin antibiotic, is approved to treat infections caused by susceptible strains of microorganisms. The FDA’s “early communication” is in keeping with its commitment to inform the public about its ongoing safety reviews. The FDA urges health care professionals and patients to report side effects from cefepime to the FDA’s MedWatch Adverse Event Reporting program. (Sources: Lancet Infect Dis 2007;7: 338–348; FDA, November 14, 2007.) More Heart Risks Noted For Rosiglitazone (Avandia) In a new study from Toronto, an older group of patients with type-2 diabetes who used rosiglitazone maleate (Avandia, GlaxoSmithKline) had significantly elevated risks of heart attacks and death. Earlier studies had drawn similar links between the drug and cardiac risks. These patients had a 60% increased risk of heart failure, a 40% increased risk of heart attacks, and a 30% increased risk of death, compared with patients taking other oral diabetes drugs. The findings suggested that for every 100 people taking rosiglitazone for four years, there 12 P&T® • January 2008 • Vol. 33 No. 1 http://www.gsk.com http://www.drugtopics.com http://oversight.house.gov http://oversight.house.gov
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