Watch

COMBINATION LIPID-LOWERING wasn’t designed to look at cancer the data from SHARP and espe - DRUGS AND CANCER RISK risk, the analysis “was performed cially IMPROVE-IT become after the fact and without statis - known. • There is no evidence that the tical correction to account for combination cholestero l- lowering multiple comparisons. Therefore, A REMINDER ABOUT TERATOGENIC drug Vytorin (simvastatin plus the true statistical significance RISK WITH VALPROATE ezetimibe ) increases the risk of of the cancer imbalance is un- cancer or cancer-related death. known ,” said the FDA. • The antiepileptic valproate sodium • Patients taking Vytorin should and its derivatives are increas - continue to do so. Further bolstering the FDA’s conclusion are interim data from ingly being used to treat condi - two ongoing, large-scale clinical tions other than epilepsy. • Providers are reminded by the he Food and Drug Admin- trials involving the combination FDA about the risks of major birth Tistration (FDA) has con - of simvastatin and ezetimibe, the defects in babies born to women cluded that, at this time, there’s Study of Heart and Renal Pro tec- who take these medications. no evidence that the combination tion (SHARP) and the IMProved • Risks include neural tube defects, lipid- lowering drug Vytorin (the Reduction of Outcomes: Vytorin craniofacial defects, and cardi o- cholesterol-lowering statin sim- Efficacy International Trial vascular malformations. va statin plus the cholesterol (IMPROVE-IT), although results absorption inhibitor ezetimibe) from IMPROVE-IT, which isn’t linicians have known for increases the risk of cancer or due to conclude until 2012, could Cyears that use of the anti- cancer-related death. ultimately shed more light on any epileptic drug valproate sodium The FDA had issued a warning association between use of the (Depacon) and its derivatives in August of last year that the combination drug and cancer. increases the risk of major birth Simvastatin and Ezetimibe in In March 2008 preliminary defects in fetuses exposed in Aortic Stenosis (SEAS) trial had results of the Ezetimibe and utero. As these drugs are increas - ingly being prescribed for other conditions, the Food and Drug Nurses should tell patients to Administration (FDA) has issued a reminder (http://bit.ly/8JRHOr ) continue using their prescribed to all prescribers of the risks to fetuses of neural tube defects, cholesterol-lowering drugs. such as spina bifida and anen - cephaly; craniofacial defects, such as cleft lip and cleft palate; and revealed a greater incidence of Simvastatin in Hypercholesterol- cardiovascular malformations. cancer in the treatment group than emia Enhances Atherosclerosis Originally used as antiepilep - in the placebo group. Its most re - Regression (ENHANCE) trial tics, these drugs have more re- cent announcement comes on showed the combination drug to cently been approved for use in the heels of a follow-up analysis be no more effective than sim - the treatment of bipolar disorder showing that the higher rate in vastatin alone in reducing carotid and migraine headache; the labels the treatment group was likely artery–plaque formation (see on the drugs have always in- the result of all cancers having Drug Watch , May 2009). Because cluded information on terato - been combined for analysis. “It the two ongoing trials are much genic risks, but the FDA fears is biologically less likely that a larger than the ENHANCE trial, that not all practitioners will be single drug increases the risk of the FDA doesn’t recommend any cognizant of those risks. The re- a wide variety of cancer types,” changes in use of the drugs at minder covers valproate sodium wrote the FDA ( http://bit.ly/ this time. Nurses should tell pa- and its related products, such 4uA1XC ), which concluded that tients to continue using their pre - as valproic acid (Depakene and neither the combination drug nor scribed cholesterol-lowering drugs. Stavzor) and divalproex sodium ezetimibe (Zetia) alone increases Nurses should also be alert to (Depakote, Depakote CP, and cancer risk. Because the SEAS trial any changes in FDA guidance as Depakote ER).

24 AJN M May 2010 M Vol. 110, No. 5 ajnonline.com