6 TUESDAY, NOVEMBER 23, 2004 UNC falls despite Beaver’s play Team unlikely to make postseason BY ANDY WALES STAFF WRITER The postseason hopes of the North Carolina volleyball team likely ended in the ACC champi onship match Sunday. In that match, the Thr Heels fell to seventh-seeded Maryland in three games 30-24,30-24,30-17. The team was unable to con tinue the excellent play it used to dispatch Florida State on Friday and Clemson on Saturday, both in THE Daily Crossword By Gerald R. 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J_ £ E c eU 1 Mr] 1 U__N_£ £ Mg oUmF ££ 7Tsi £ A £ ISIO Na! rMa £OE■ T I TJo K N I F £■ I IMNSMEDEN y|e|als|tßrla|g|sßr|a|nld ORTHO EVRA® (NORELGESTROMIN / ETHINYL ESTRADIOL TRANSDERMAL SYSTEM) PtfMsshotrid bo counseled ttwt this product doot not protect agorot HlVinfec- Son (AIDS) id oiier aocuxßy tiansnwttod Ikiki, only ORTHO EVRA* Is a combination transdermal contraceptive patch with a contact sulace area ot 20 cm 2. It contorts 6.00 mg norelgestromrt and 0.75 mg ethinyl estradiol (EE), and releases 150 micrograms ot notelgestromin and 20 mbrograms of E£ to the bloodstream per 24hours. IMPORTANT NOTE - This Information la a BRIEF SUMMARY ot the complete prescribing Information prodded wHh the product and therefore should not be used ae tie bans (of prescribing the product This summary wa a prepared by deleting Iran the complete pre ecriblnßlnfarmatlon certain text tables and retorenoee. The phyeWan shouldbe thorougWy temllliriiibh the complete presatimßmionmtlonbeoce prescribing the product NOKXTtONS AND USAGE ORTHO EVRA* is indicated tor the prevention ot pregnancy. Lke oral contraceptives, ORTHO EWA* s higtity effective I used as recommended in this label. ORTHO £WA* beeneOeen Netted Air tnik net mmuM Her nee bi swan-cy CONTRAMHCADONSc ORTHO EVRA* should not be used it women who currently have the folowtig conditions: 1. Thrombophlebitis, thromboembolic disorders 2. A pest history ot deep veil thrombophlebitis or thromboembolic disorders 3. Cerebrovascular or coronary artary disease (airent or pest history) 4. Valvular heart dbease wtti complications 5. Severs hyper tension 6. Diabetes with vascular hvobement 7. Headaches with focal necrological symptoms 3 Major sirgety wlh prolonged immabillzaticn 9. Known or suspected carctwma of the breast or pereoral history of bresst cancer 10. Carciioma of the endometrium or other known or abnormal genial ljteedrtgl2.Choteetetic jaundice ot prepiancy or jaundice with prior hormonal contraceptive use 13 Acute or chronic hepatocellular disease with abnormal liver function 14. Hepatic adenomas or carcinomas 15. known or suspected pregnancy 16. Hyperssnstvty to any component ot this predict WARNiWS Cigarette smoking Ineiwases the risk or smoking (15 or more cigarettes per day) and Is quits merited In women osar 36 vents of ege. Women who um hormonal contraceplvee, Including ORTHO EVRA*, shook! be atronjly advised not to smoke. ORTHO EVRA* and other contraceptives that contaii both an estrogen and a progestin are called combination hormonal contraceptives. There is no epidemiologic data available to determine whether safety and efficacy wih the transdermal route ot admhtelration would be different than the oral route. Practitkrors prescribiig ORTHO EVRA* should be famiiar with the followiig information relating to risks. The use ot combination hormonal contraceptives Is assockted wiltt increased risks ot several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and galUadder disease, althatfi the risk ot serious morbidity or mortally Is very small b healthy women without underlying risk factors. The risk ot mutiny and mortality Increases significantly In the presence ot ether undertyng risk factors such as hypertension, hyperlpidemias. obesity and diabetes The Herniation contahed In the package Insert is principally based on studies carried out in women who used combination oral contraceptives with higher formulations of estrogens and progestine than those In common use today. The effect of long-tetm use ot combination hormonal contraceptives wilh lower doses ot both estrogen and progestin adm h stared by any route remans to be determined. ThroutfHut this labeing, epidemiological studies reported are ot two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a meas les of the relative risk ot a disease, namely, a ratio of the Incidence ot a disease among oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual dnical occurence ot a disease. Cohort studies provide a measure ot attributa ble risk, vWtlch is the cNTerence n the incidence ot disease between hormonal contraceptive users and nonusers. The attributable risk does pro/ide information about the actual occu rence ot a disease in the population (adapted !romrefs.2and3withthe author’s permission). For kflher information, the reader Is referred to a text on epidemiological methods. 1. Thrombosmbolc Disorders And Other Vaecular Problem* a. Thromboamtxtitm: An increased risk ot thromboembolic and thrombotic disease associated with the use of humoral contraceptives Is well established. Case control studies have faind the relative risk of users compered to nonusers to be 3 for the first episode of superficial venous thrombosis, 4 to 11 for deep vest thrombosis or pulmonary embolism, and 1.5 to 6 tor women wth predisposing conditions for venous thromboembolic disease. Cohort studies have shown the relative risk to be somewhat lower, about 3 for new cases and about 4.5 for new cases requtttg hosptaltza tkm. The risk of thromboembolic disease associated wih hormonal contraceptives Is not retried to length ot use and disappears after hormonal contraceptive use Is stopped. Atwo- to tour-fold increase h relative risk of post-operative thromboembolic complications has been reported with (he use of hormonal contraceptsres. The relative risk of venous thrombosis In women who have predisposing cond lions is twice that of women without such medical con ditions. It feasible, hormonal contraceptives should be discontinued at least fou weeks prior to and for two weeks after elective surgery of a type associated wHh an no ease h risk (X thromboembolism and dung and following prolonged immobiiarikn. Since the Immediate postpartum period Is also associated wih an naeased risk of thromboembolism, hormonal contraceptives should be started no earlier than tou weeks after dslkmy h women who elect not to breest-teed. In the large clinical triak(N= 3,330 with 1,704 women-years of e*eue), one case of non-fatal puknenary embolism occured duing ORTHO EVRA® use, and one case of post-operative non-fatal pulmonary embolism was reported following ORTHO EVRA® use. I Is unknown If the risk ot venous thromboembolism with ORTHO EVRA® use Is dilerent than win use ot combrtation oral contraceptives. As with any combination humeral contracep tives, the clinician should be alert to the eariest manifestations ot thrombotic disorders (throm bophlebitis, pulmonary embolism, ceretrovascular disorders, and retrial thrombosis). Should any of those occur or be suspected, ORTHO EVRA® should be discontinued immediately, b. Myocartflal Infarction: An hcreased risk of myocardial Infarction has bsan attributed to hormonal contraceptive use. This risk Is primarily h smokers or women wlh <4her undertyng risk factors for coronary artery disease such as hypertension, hypercholesterolemia, morbid obesity, and diabetes. The relatNe risk of heart attack fu curent hormonal contraceptive usets has been estimated to be two to sk compared to non-usere. The risk k very low utder the age ot 30. Smoking in combhatlon with oral contraceptive use has been shown to contribute sub stantially to the stddence of myocardial infarctions at women at their mid-thirties u older wlh smokng accounting for the majulty ot excess cases. Mortality rates associated with circula tory disease have been shown to mease subetantialy in smokers, especialy it those 35 years of age and older among women who use oral oontraceptkres. Humoral contraceptkies may compotixt (he effects ot well-known risk factors, such as hypertension, diabetes, hyperß)l -demias, age and obesly. it particular, some progestiis are known to decease HDL choles terol and cause glucose ntoierance, while estrogens may uaate a state of hyperinsulnism. Hormonal contraceptives have been shown to hcreese blood pressure among some users (see Section 9 In WARNINGS). Sim lar effects on risk factors have been associated with an increased rMs of heart disease. Hormonal contraceptives, nctudng ORTHO EVRA®, must be used wtti caution In women with cardiovascular disease rkk factors. Norgestimate and noratoestromn have mhimal androgenic activity (see CUNCAL PHARMACOLOGY in ful Presaibrtg rttormabon) There Is some evidence that the risk of myocardial inlirction associated with hormonal contraceptives is lower when the progestin has minimal androgenic activly than when the activity Is greater, e. Cerebrovascular diseases: Hormonal contraceptives have been shown to increese both the relative and attrtutable risks of cerebrovascular events (thrombotic and hemonhsgic strokes), although, In general, the risk is greatest amatg older(>3syesra), hypertensive women who also smoke. Hypotension was fouid to be a risk factor for both users and nonusere, tor both types of strokes, and smoking Interacted to increase the risk ot stake. In a large study, the relative risk ot thrombotic strokes has been shown to range from 3 for normotenstve users to 14 for users with severe hypertension. The relative risk of hemonhagic stroke Is reported to be 1 2 tot non-smokers who used hormonal contraceptives, 38 tu smok ers who did not use hormonal contraceptives 7.6 tu smokers who used hormonal contra cepbves, 18 for nor motensive users and 25.7 tu users with severe hypertension. The attributable risk is ako greater In older women, and. Dote-raHted risk ot macular cheese tram hormonal contraceptive* A positive association has been observed between the emourt ot eetrogen and progestin h hormonal contraceptives and the risk of vascular disease. A decline rt serum hidi-denelty Ipoprotelns (HDL) has been reported with many progestational agents. A decline >i semm htfv density Ipoprotelns has been associated wHh an increased incidence of scheme heal disease Because estrogens increase HDL cholesterol, the net effect of a hormonal con tracepUve depends on a balance achieved between doses of estrogen and progestin and the activity ot the progestin used rt the contraceptives. The activity and amount of both hormones should be considered n the choice of a hormonal contraceptive. * Perk stance of rM of vas cular disease: There we two studies that have shown persistence of rkk of vascular disease tor evw-usere ot combnation hotmoral contraceptives. In a study in the Ihfed States, the risk of developing myocardial intwetion aflw dkcontrturtg combination hormonal contraceptives persists tor at least 9 years for women 40-49 years who had used combhatkm hormonal con traceptives tu five or more years, but this increased risk was not demonstrated rt other age rroupe. In another study n Great Britain, the risk of developrtg cerebrovascular disease persisted tu at least 6 years after disconthuatlon of combination hormcra! contraceptives, a though excess risk was very small. However, both studies were performed with combhatlon hormonal contraceptive formulations contahhg 50 micrograms u higher ot eetrogera. It Is unknown whether ORTHO EVRA* k district from other combnation hormonal contrace(tives wlh regard to the occuirance of vanous and arterial thrombosis. 1 Estimates 01 Mortaity from Combination Hormonal Contraceptive Uo One study gathered data from a variety ot sources that have estimated the mortality rate associated with different methods of three games. The quarterfinal and semifi nal matches showed the potential UNC possessed all season. The final match represented how they played for most of the season. “We always talked about play ing hard, playing smart, playing together,” said sophomore middle hitter Amy Beaver. “Once we played together, it went really smoothly, and we started to dominate.” The Tar Heels dominated the Seminoles throughout After getting swept during the regular season, North Carolina beat fourth-seeded Florida State 30-17,33-31,30-24. Beaver set the tone early. 21 Homesteader 22 Greek letters 25 Intense hatred 26 Inclined to flow 27 Player 29 Actor Lew 30 Ms. Caldwell 32 One Jackson 33 Soap plant 34 Not as refined 36 Actor Omar 38 Air shaft 41 "Evil Woman" grp. 42 Postponed 1 TANARUS““ 6 7 io |n 12 13 20 1 ' 21 122 ■■tiiidteiiniUtei ■ - 30 ] M 1 3; 3? 34 35 3^Mp9 __ " 42 _ ■■44 46 “ ' ~54 55 56 57 ” f 158 59 60 61 62 63 _ '■■64 BBB7T 66 ' ~ " " " + "' .SHjp 6S jHp' ' contraception at diluent ages. These estimates Indude the oombried risk ot death associ ated with contraceptive methods plus the nek attrtutoble to pregnancy rt the event ot methoo talure. Each method of contraception has Its spectic benefits and risks The study conducted that with the exception ot combnation oral contraceptive users 35 and otter who smoke, and 40 and older who do not smoke, mortality associated wlh all methods ot birth control is low and below that associated with chldbirih. The observation of a possHe increese it risk of mutaliy wlh age tu combination oral con traceptwe users k based on data gathued In the 1970* but not reported until 1983. Current dnical recommendation Involves the use of lower estrogen dose fumulations and a cueful consideration ot rkk factor*, hi 989, the Ferdltiy and Maternal Health Drugs Advisory Commltee was asked to review the use ot combiratiai humonai contraceptkies in women 40 years of age and over. The Committee concluded that although cardkwascular disease risks may be increased wlh combination humoral contraceptive use alter age 40 h heallhy non-smokng women (even with the newer low-dose formulations), there are also greater potential healh risks assockted wlh prepmney In older women and with the alternative surgical and medical procedures flat may be necessary If such women do not have access to effective and acceptable means of contraception. The Committee recommended thatthe benefits ot low-dose combi nation humoral contraceptive use ty heathy non-smoking women over 40 may outweigh the possible rikrs. Allhough the data are mainly obtaried wlh oral contraceptives, this is Ikety to apply to ORTHO EVRA® as wel. Women of all ages who uee combination hormonal contra ceftives, should use the lowest possible dose formutetion that Is effective and meets (he irtdi vrtual patent needs. 8 Carcinoma Of The Reproductive Organs And Brents: Numerous epidemiological studies give conflicting reports on the relationship between breast cancer and COC use. me tkk ot havrtg breast cancer dkgnosed may be slightly released among current and recent usere ot combination oral contracepti/es. However, this excess rkk appears to decrease over tine after COC dkourtlnuatkin and by 10 years alter cessation the increased risk disappears. Some studies report an increased risk wth duration ot use while other stud ies do not and no consistent relationships have been found with doseu typed steroid. Some studies have (and a small increase it risk tu women who fist use COCs before age 20. Most studies show a similar pattern ot risk wlh COC use regardless ot a woman* reproductive history or her family breast cancer histuy In addition, breast cancers dkgnosed In current u ever oral contraceptive usere may be less dnicaly advanced than In never-usere. Women who curendy have u have had breast cancer should not use humonai cuitraceptlves because breast cancer k usually a humorally sensitive tumu. Some studies suggest that combnation oral contraceptive use has been assocnted with an increase rt the risk of cervical Nraep- Ithetal neopksk n some populations ot women. However, there continues to be controversy about the extent to iMdch such fhdhgs may be due to dlferances h sexual behavior and other factors. In spte of many studies of the rektkmshp between oral contraceptive use and breast and cervical cancers, a cause-and-eflect rektkmshp has not been established. It Is not known whether ORTHO EVRA® is distiid from oral contracepXkes with regard to the above state ments. 4 Hepatic Neoplasia: Benign hepatic adenomas are assockted with hormonal con traceptt/e use, the incidence ot benign tumor* Is rare it the united States. Indirect calculations have estimated the attributable rkk to be In die range of 33 cases/100,000 tu users, a rkk that rtcreases after tax u more years of use, especially with hormonal contra ceptives contalnrig 50 mkxotrams u mue ot estrogen. Rupture of benign, hepatic adenomas may causa death through iitra-abdomrial hemorrhage. Studies from Britain and the US have shown an hcreased ridr cl developing hepatocellular cucinoma n long term (* 8 yearn) oral contraceptive users. However, these cencere are extremely rare P the U.S. and the attrbuta ble rkk (ft* excess incidence) ot iru cancers P oral contraceptive usere approaches less than ohe per mllbn usere. I k unknown wheffier ORTHO EVRA® Is distiid from oral contraceptives P this regard. 5 Ocular Led on* There have been dppal case reports of retinal thrombosis associated with the use ot humoral contraceptees ORTHO B/RA® should be discontinued I there is unexplained partial u complete loss of vision: onset of proptosis u diplopia; papilledema; u retinal vascular lesions. Appropriate diagnostic snd therapeutic measures should be tndertaken Immediately, a Hormonal Contraceptive Use Before Or During Early Pregnancy: Extensive epidemiological studies hsve revealed no increased risk of birth defects P vmen who have used oral contraceptives pnu to pregnarxy. Studies ako do not indicate a teratogenic efted, parttcularty p so far as cardiac anomalies and imb reduction defects are concerned, when oral contraceptives retaken inadvertently during early pregnancy. Combination hormonal conlraceptiveseuchasOßTHOßlßA® should not be used to nducewithdrawalbleed mg as a test tu pregnancy. ORTHO EVRA* should nd be used durpg pregnancy to treat threat eraduhabltiialabortPnltisrecommendedthatfuanypatientwhohasmissedtwoconsecutive periods, program* thould be ruled out It the patient has not adhered to the presetted sched ule fu the use oIORTHO B/RA® the posstiillyotpreflranqf should be corektered at the time ot the tret missed period. Hormonal contraceptire use should be discontinued it pregnancy k confirmed. 7. EMbtaddar Meats* Earlier studies have repotted an Pcreased lifetime rela tive risk of galbtaddw surgery p users and hormonal contraceptives and estrogens. Mue re oent studies, however, have shownthat the rektive risk of developing gaiiladder disease among hormonal contraceptire users may be mPPtal. The recent findings and mnima! rkk may be re lated to tie use ot hormonal contraceptive fumulations contanlng tower hormonal doses ot estrogens and pnogestPs. CombPation hormuial contraceptives such as ORTHO EVRA* may worsen existing gallbladder disease and may accelerate the development of this disease P previously asymptomatic women. Women with a history ot combination humonai contraceptive-related choleelask are mue Ikely to have the and toon recur with sutKequart combnation humeral contraceptive use. 8 Carbohydrate And Upid Metabolic Enact* Humoral caitraceptives have been shown to cause a decreese P glucose tolerance P some user*. However, P the non-dkbetic woman, combnation humonai contraceptives appear to have no efted on tasting blood glucose. Predkbetic and diabetic women Pparticuiar should be carefully monitored while takng combnation humoral conkareptives sudi as ORTHO E\4tA®. P dnical triak wlh oral contraceptives contanlng ethnyl estradiol and nugestimate there were no dnicafy significant changes P tasting blood glucose levels. There were no dPically significant changes P glucose levels over 24 cycles of use. Mueover, glucose tolerance tests showed no dPically significant changes from baseine to cydes 3,12 and 24. P a 6-cycle dnical trial wth ORTHO BIRA® thus were no dPically significant changes P fasting blood glucose from baseine to end ot treatment A small proportion of women will have persistent hypertriglyceridemia whle taking humonai contraceptires. As discussed earlier (see WARN INGS 1a and 1d), changes p serum triglycerides and tpoprdeP levels have been reported P hormonal contraceptive users. 8 Bwated Blood Prernr* Women wth skplfcant hyper tension should not be started on hormonal contraception. Women with a history of hyperten sion u hypertension-related diseases, u renal disease should be encouraged to use another method of contraception. I women elect to use ORTHO EVRA®,they should be monitored closely and It a ckiically signKcant elevation ot blood pressure occurs, ORTHO EVRA® should be discontinued. Fu most women, elevated blood pressure wtl return to numal alter stopppg hormonalcontracettlves, and there Is no difference P the occurrence of hypertension between turner and never users. An Pcreese P blood pressure has been repotted P women taking hormonal contraceptives and this Increase k mue likely P older humoral contraceptive users and with extended duration of use. Data from the Royal College ot General Practitioners and subsequent randomized triak have shown that the incidence ot hypertension Pcreases wlh increasing progestational activity, to. Headache: The onset u exacerbation of migraine headache u the development ot headache with a raw pattern that is recurent, persistent u severe requtes dscontruation ot ORTHO EVRA* and evaluation ot the cause 11. Bleeding kregutarities: Breekthroutfi bleeding and spottpg are sometimes encountered P women using ORTHO BIRA®. Ntp-hormonal causes should be considered and adequate diagnostic meas ures taken to rale out maigrancy, other petbotogy, u pregnancy P the event ot breakthrough bleeding, as P the case of any abnormal vaginal blesdng. It pathology has been excluded, tPie or a change to another contraceptwe product may resolve the bleeding. P the event of amen otrhea, pregnancy should be ruled out betore Plating use ot ORTHO EVRA®. Some women may encounter amenorrhea u oHgomsnonhea alter discontinuation ot humoral contracep tive use, espedaly when such a condition was pre-existent. BtoedPa Patterns: p the dnical triak most women started their withdrawal bleeding on the fourth day ot the drug-tree Interval, and Ihe median duratiut ot withdrawal bleeding was 5 to 6 days. On average 26% of women per cycle had 7 u mue total days of bleeding and lor spotting (jhk Pcludes both with drawal flow and brsakthraigh bteadpg and/u spottpg). 12. Ectopic Pregnancy: Ectopic as well as PtrauterPe pregnancy may occur P contraceptire failures. PRECAUTIONS: Woman shoikdbecouneeted that ORTHO EVRA* does not protert again* HIV Infection (AIDS) and other sexually transmitted Infection*. 1. Body Weight *l9B be. (90 kg): Rasuls ot dnical triak suggest that ORTHO EVRA® may be toss effective P women wlh body wetfit 1 (J.tftiHams). Turnover* -12 (Mav 3. feny 3. M.VWlams 2, Fettixn 2. McCants. Thomas). Steals -15 (May 3. Manual 3, M.VWHarm 3. Felton 2. Noel 2. McCants. Scott). technical fouls None Attendance 2.600 seven assists in 26 minutes. Felton said it was the first time he ever missed a game for any reason, even injury, since he started play ing organized basketball in grade school. May had 18 points and eight rebounds for the Tar Heels, while Rashad McCants had 13 points. Mike Hall had 10 points for BYU, which finished 13-for-30 from the field (31.6 percent) and had 27 turnovers. North Carolina’s biggest lead was 39 points, which it reached three times, the last at 83-44. The biggest margin of victory in the 21 years of the tournament was Boston College’s 108-61 win over Chaminade in the opening round in 1993. ccvrrrr. err, Tar Heels finish 10th atNCAAs FROM WIRE REPORTS The No. 10 North Carolina wom en’s cross country team finished 10th at the NCAA Championships Monday morning at Indiana State University in Terre Haute, Ind. The Tar Heels finished the race with 336 points, edging Missouri to finish in the top 10. Colorado won convincingly, tal lying 63 points to take the crown. Duke was the top ACC finisher, plac ing second overall with 144 points. North Carolina junior Carol Henry was the only harrier from an ACC school to crack the top 10, as her 6K time of 20 minutes, 42 seconds was good for seventh. Senior Erin Donohue was next to cross the line for UNC, finishing 44 th in 21:17. Alice Schmidt, Jessica Perry and Meghan Owen rounded out the scoring for the Tar Heels. Nicole Boykin and Jennie Sucher also competed for North Carolina, but did not score. “We are very happy with a top -10 finish,” said Coach Michael Whittlesey. “Anytime you can fin ish in the top 10 in the country, it’s been a great year. I thought we had a solid race and we were tough competitors on a muddy course.” Henry received All-America honors for her performance. After finishing eighth overall in 2003, UNC has now finished in the top 10 at the NCAA Championships in back-to-back years for the first time in school history. Colorado AD steps down BOULDER, Colo. Colorado athletic director Dick Tharp resigned Monday, ending a nine year tenure sullied by accusations of recruiting violations and fiscal mismanagement. The resignation came just months after the school’s football program was rocked by allegations that sex and alcohol were used to entice recruits, and lawsuits accused play ers or recruits of sexual assault. New allegations about fund raising problems surfaced this month. The school told the NCAA last week that a small booster club that had not been audited under university auspices bought equip ment for the athletic department, an NCAA violation.