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Appendix 2 Final Text for Patient Labeling

Date: Oct 1978 (est.)
Length: 5 pages
03590317-03590321
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Kennedy, D.
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03590317/03590321
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N14
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03589878/0476

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FDA, Food and Drug Administration
Federal Register
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07 Jan 1999
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Federal Register
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EXTR, EXTRA
MARG, MARGINALIA
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chv99d00

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Page 1: chv99d00
277 APPENDIX 2 Final Text for Patient Labeling 1 t HKtcr SvuwAKr PAncur PAcK.toc I+sntr ~ Ch;arette.amoklpa IGcrraw•s thc.r+xof re: nous adver, r e/frets nn the heart and btnp.l re;tseis from onl eoptracrpnce u.e. ililss ri•k Inarreeee sittt eee anda•IlhIlaty smoklne t1i.rn more elkarett.•s pertlAyl nndu au4te marked In eumen' orer 71 yrus.of tue. Women 'ho tlle orTlirorltr]e^ptlCei should notsmoke. Oral contraceptivn taken as dlrect- ot are about'9!N'a eftccti:•e In prerent- Int prcttn.vtcy. (The minl-t•ill. hoa•er. er...Is somewhat 1csss effretlVr..1. ForKrt- tlng to take yourpills Incrraaos the ctt3ncc of pregnancy. Woiecn who have or have had tlot- LIIIC dl3ordcrs• cancer of thc hrrv.t nr tex or'dans. unexplained va-lnalblr:•d- In4l i strokc. hrort attark. a•l; tna, rc•torts, or w•ho sus7cct tL•ry tnrT he prca7nant ihouldnot use oral contra-eepLiees. Atost sldeeffects of the.pltl nrc r.ot sertous.•The most.commor.stJr effectsarenausea• vomitin¢.. bf•edlaK be• t'uecn menstrual perilll:, a•cteht lain. andbreast tenderness. Hure:•er. properr use of orat eontrarepth•c.~re- Quftee thattluy bee taken under ;•our do.tor's en::tin::ous xlprr:'islr::. ti:-.- causc they can t:•a;::cci:•tcd w:;It:crl- ouaside effecla xhlrh inayy he fatnl.. rortL'na1eIP.r th^aeoCCur very Inlre- rlnrr.tty. The srr:nut shlr effrcts arr:, ll DIcw1 clol:: inthr Ire?% hlntr:, braln. ht•+.rt orothcr orcans.acd hem- orrhn;r Into lhrbrain.dile roburslin` of a blusd ressel. . 2. Wrer tumor.. wadeh may rupture and caus: sorerc Weedta,.. 3. Blfth.tkfcrlslf the p:ll ts taker zhile;•ou nre p'rFnant. 4. Hiahhlood prr.rure.. S. Ca1lbMdder di_cise. The sytttptol. :vaocial cd ailh I hcz,• ser7ous Sidei:IMl3:are di:,rlic7rd In tF.ce detziled IeaO:t¢ivenyou lti?h yourr srpplp of rills. :7otif•vy panr dc:tor & you noll7ee anFunusualp:iynual dts• turbance:rhilo-t:+an` the pill. Thc cstroSCa, in orai'cor.tnrrpilrs hra been round t•j ra:<c br:uvcancrr and other cattrcrs in certaii a-amal5. Thaae findtn^s sl:4gcsl that.o:r1 con• traceptirc3s ma; a Iso cause canccr In hwr.utt. lIo-x-crcz studies to c!ate in women taking currontlpmancct-•d ornt t•ontraecpGres have not cor:firmedfltat.oral confra,cpth"cs eauso cancer In httmatt.. The detailed :ranet describes more eomnletcl•vtae bencflts and ri:ks of aral eosuraceptira-..tt al.so procid•:s In• fornttdlon on other forms or coolra•eeptfon. R,ad it carefully. If.,ou have any Oue7:;tiJns.3•onsuC yrour de+rlor. CuafEon. Orrl eunlrncrpli1'e; are t.f no raWe ttl the F"errntlnn er Iren:-ment ofvenerr-[ disrasc: Dr.ensa °.trtgrn• I_tssctY: v1nAT Yn0 SI.G•J•..D K`rC-•N A6Or17 OM.LL co::: r.u•u•rt rs Oral contr•r.r, r.t;ra• ('•the r:P') arn thee nvst effccttre a•ay. (nv,:•pt f->r s;crliliationl ln nrrr.•°t prr;:taroS• Theyarry alrr+cnn.rninu r.nd, for most a-omrn.. .'r•e, of f.rriJU•: or u!t- pletic+.r.r. side c'fecis..Oral ce••ireecp- :Irrs eu^:6 alic :ya Ar ilraler arr continUotlsdV I~C:': is/On Of :t pl iy'Xican. (If ardont contr-ce.+icr Is ap• prored fnr indi:allca! otncr t!s.n t•on• tr.ueptloa /i-•locid 3 my: Orrho- rforum 2 mC. Qrtho•t:orum !0mgl0 the manufmch:ror maymrnlfr•ny thn.r IhdteaLions in lilr lise Par.--mPh in this sectinn e'r:1c/1U• Ihnt lhr infur- rnition in t/ti.+ L•nfl.•1 ur.<t••r tI•r hred- IifmK "Who YOt. tll- ('rnlCon• lr:tecpllr!•s.'• '!-1•r b:cnr.•r.;. nf Olal Conlrn_I:vlirrs.°nrtl •^.fo•rw in t;- Ornl Co1:S::.c.t.licrs c; fr:4'. i..tl n<. •- p4lcablc w:N:.n IrrsclltuF; nrr u~rd:lnr. 01 hPr itxlit 8 t iu.ls./ .ItI L:4ltaturtlrt.that ans nr.r..•:.n. tntlaid.•rs u•ir.:t an.nrr.l r.3nlr^:•cqa;,r uadcrn'and: It:.• trvol:.d. Al- LhouF-'th the Prat conttacr^II•..•;; has•• Impor•~.nt. ar;ruua,t•s rt•-.otdar.. mathnds of c-^.'rlc' ?ttOll, . th.'TY hal'C certain rc:s •hnCno other method A2-5
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278 hat. OnlyYou can decide whetlter the advantages ax worth tite.e risks. This leaflet u al tc9l you about t1e moat Im-. porlnnt rtsks.It will ecp,a:n how yos can help your dar.or prrscr:be tl:e 9:7I aa so:cly as pos:ible bytr:.^t, about yourself a.M bet7g alert 1ir t:-z earilest atgv ot trouble. And It will tell you how to we t.^.e pill propet:y„ aa that It wal'be as ef:eetlve aa ppsl-ble. There ts.r.aares deta::ed Is:furma-tlon available hrthelcaf:et propared' for doctors. Your pharmarl.st caa show yau a CopY: YoYY maY noed your doe- torY help In understanding parts of IL Wxo BNOOtn Hot Use Oa-tt. CoIRLLAtrrrrvn. A- If youu have any of,the folCowln;g conditions Youahould notuuc the pill: Il,Clatf In thelegsorlun gs.. 2. Anglna oecturls. , 3. Y.I1own or ]u.ipeetld cancer ofttte breastor sea argans. 4. Unusual vaginal bleeding tllat.hne not yet beendingposed. 5. Hnown or sa.fpectld pregnanry. H.: If youhave had any of the fallpv tng conditlans you shoul0no6 we the pill: 1: Hcartatltck or Strokp. 2. Cibla Idt thc Icgsor ]tmgs.. .Y C. ClMretteSrtTOktne mCroasfa the rtii of TvNOUr advme efrecta on tne hrnrt.anbloud vevelt Iroan ural eontraerpulve uM.. Tnls rhk' Inrreeaea wlth aae aaad w4th hewry mekmg (1i or more elgarNtes perday) and b aume marked In woanen over ]S yean of age..WOmen shG use oral tontrxntlrn ahould npt smnke. D..If You hare s0anty or Irrrgular prrlods or are a youngwomnn adthout a regular cycte. Youshou;ld usee an• other method ot eGntrarcptlon be- cavse- If.you we the plll. Yuu may have dlfflcully'be<oming pregnana or mayy fall Lo have menstruall pcrtods atter discontlnuing the pill. Ogcmtra To Ust Oaet. CONTMCVrlvts 11 you do.not have any of the eam:1-tlons listed above and are trilnking about ming oral eontraceptava; to heip you deeide: you needInformatlon. about the advantages and'rlsks of,onl~ contnceptivrs and of Otlier contnecp- tlve methods at.well..Thlsleafletde- scrlbes the advantages and rtsk.s of~ oral contraceDtlvea Exttpt for sterll- Iz~ttlon, theIUD'and abortlon. wh/ch have thelr ow.n escSUSi•:e risks, the only risks of other mrthods of contn~ erptlon are t)iose duee to prcgnancyshowld:!he method fall. Your drxtor can aruwer buestlons you may hs.ve with respect tn.other methods af;can- llac<ptlon. He e n.aL'o an.twer any. Questtons you may have a(ter reading th.is Ieaflet On onl!cantrnrrptlves-l. what OnlContracrTatlvesAre and How They Work. OraL.Cuntracep-tivea are of tw'.a lypes„ The mnSt common, often sim;plY ca11Pd "•he.plll"' 1 NOTICFS ts a tom•binatlon of an estrogen and a progestngcn. the two klndsof female hormoncs. Thee amount of estrogen and'. pro¢estogen can vary, but thee autuun:.of cstrogen Is m;a t Itnporttnt becawe bothh the effretivrness and sume of, the dangers of onl contracep- llt<s are related to ttSe amountof ea• trog,en TTtls kind of oral centraerptlve works prlnlcpa::y by prerentingg n- lease ofan egg from the ovary. When the amount of estrogen Is 50'Inlcrw grams or ntore,. and the pillls taken;as dlrected- oral contracepnves are tnore than 99qe effective (i.e.. theree would be less than one pregnancy'. If 100 women Itsed the pill for 1 yev)..PL9 that can- taln 20 to 35 mlerogratns of eslrogen varysllghtly bt effeetiveness, rangtng frem 98 eto more than;09;e effeetive.. fhisnufaeturerM may Insert premancy nte forr the monufacturer's product foucd tn clinlcal trials, If, product I, a eombinatlOn). Thee second:type of oral cnntrecrp- ttve. often called the"minl-plll'-', can-. Lalna only a prosestogen. Itworks In pa[t by' preventing releaSe of an rgg from, the ovaryy buc also by keeping spcrns from . rcaehtng the egg and by makingtlte utenu./tvombl leas receo-tlve to unyfertlllaed egg that reaches It- The min0-pNl Is less effective Llsan thee lombinatlonoral contnreptlve.. about 97aeffecltva fManulacturrr may.lnsert pregnancy rate for the manutaatorers product.found In clW- cal1 trlti,ls. if product Is a progcstogen+ only' oralloontracrptlve.lIn addltion' the progestoren-oNY pill has a ten- deney tocaase Irreeularblcediilg wtitch mayy be QuttetnaunreNCnL Or cessation of bleeding enllrely.. Thee prugcstogen-only pill Is wed desplteIts lower effectlvenCsin the hope that' IC o.111 prove.not to have sama of the scrfaw sEde~ effects of' the estrogen- contaih,ing pill (see belo•e) but Itls notyeG eertnln thab the nlinl.plU doas In facthave fewer serlouu slde effeets The dlscur.fun below, wnile based mainly on Ilhforrnatlon aboutthe trom- binallon pllll:,sliould be considered to apply ss we41 to the minhpLll, 2,Olhcr Noruurg)cal LVays to Pre- vent.Preg~nancy. N thls leaflet will ea- plaln: oral eontrneepllves haee sRveral scriow rtsks. Other methods of con- traceptlon haYe lesser risks or none at alt., Theyy are slao.less effectlve than oral[ eonLrnccpLlveS, but, used properly. may be effeotlreenougtte for manyy women. The following table givcs~re- ported'~ prrl:nnncy rates ( l.he numtxr of vromrn outt of 100 who would beeome prrgn: nl In II sear) for these methods: 0 Yus:a.xein Yra iaa wotten Ita YGa Intmutenne drrteetlllDl.Ir ttnanl-6; phal•~tna[m ./lh apennleldal. produeu (cre.ime or k111r./- 3-2C; CunJ-rubbrr I,: 7-]a:. Artmd foamn. r-29: Jelure aand err.ma. (36:: d?3l . Perlodfb aCitltfenee.lmythm)all t)'pes.. leas taan 1-47- t... CqfndM.meth.ud. ,t(+.7: 2Trmperamre method. t :o: ]. Temperatwre method-mtenv eNr tn poSt.ovu4e4orY phare- lesa tnan. I-7t i.' V'.'w mcthod. 1,25: No cantneeptlDa..60-g0.. Thee flptres (eseept for the IUD) varyy widely becawe people dlffer IEt how well they use ca<h rncthod.l Very faithful Ilsen of . thee various methods obtalnvlrygood results. eitept'for wen o( the calendar method of perl. ed0eabstinence (rhythm): Escxpt for theIUD; effectlve.wc of these meth-s ods requires sGmCwhatmoreeffort Uian.slmply taking a single pill ~every morning, but It ls an effort that many touples undertake successfutly.. Your doctor ean tell'you a great.deal more aboutthese methods of ,contnccptlon-. 3. The Dangen of Oral ContnMp- uses. a- Cfrevlalorpdisorders.(abnormaLy btood clo0lt'npand sfroke due ta Acm- orrAaOe.). Blood clots (In various blood vesseLs of the body) are thee most common;of tUe serious side effects ofoval eontrarepth•es. A clot can result In.a stroke ((f the clol Isln the brLn), rA heart attack (Ifthe elot Is tn a blood vesel of the tfeart); or a Dulmonaryemboltlts (a.clotwhieh forms In the Ieas or pelvis.. then bretuts off and travels to the lumts):..Anyof these canbe fataL..Cl'otaalso occur rarely' Inthe blood veseels of the eye..reaulting In bllndnessor Imps)tment of vlslon In that eye, There Is evidence that the tisk ofclOtting Inaresseswlth higher estrogen doses.,It Is therefore Impor- tant tok'eep the dose of estrogen as low at porslble-so long ae the ora3 con- traeeptlve wed has an a[aeptabl! pregnancy rate and:dosen'tcawe uo- acceptable ehanges In the mensttual pattern. Furthermore.. clgarette: smak- Ing by oral contraceptive wen Uh- crcues the risk of seriow advcae ef- fects on the heart sndb4ood veucls Thlss risk lncrea<es with age and wtth heavy, smoking (13 or more cigarettts per diy)-d:beglns to oetome.0uite marked in women over 35 yean oYage: For thbreuon, women whouse oral contraeeptlves should notstnoke. The rlsk of abnormsl ciolt/ng In• creasea a'1th age In both wen and nonusen of oral contraceptlves,. but tltie Increased'risk from the contracep- tlte appears too oe present at all ages.. For oral eontraaeptlve wen Imgener-al, Ithas becn estlrnated thnt1n wromenbct:een the; aers of 15 and34 theruk of death dJlelo a clrculatery disorder is about IlIn .1 C'.000 per year. , V:hereLt- for narltlsCr] the rate is abClll I In 50:000 pcrYear. In the age group75to 44, the risk is estimatud t0 be about I In 2.500 pcr 1'eardor oral cen- lnceptlve usan and about I In 10;000 per year for.nomtcen. Even wfthuut thee plll the risk of hnvlnt; a hra.rt nttack Increases with rEDfkAL eECISrE2,.YOL /3. N0.31-TUEIDAY, IANUAEY41, 1971 A2-6
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279 427:- . HoTICS , age and Is also Increyed Dy.sueh heart attack rlsk facton m high blood prrs• aure. hikh ¢hol¢sterol..obcsityi dinbe• tes, and clgare4te amoking- Without asy risk factors presen4 the use of oral contra¢eptlves alone may double the risk of heart attack. However, thee combtnation of citarette:smok9ng, cs•Decfallyheavy unoklhC, and oral cpn-tracepth'e usee greatly Incrcasrs the risk of heart aftack... Oral Con 'tiye uxers':bo smnke.nre. cut 5 tIm:re mpte Ikcly to.~t.nce ahcart attack t an -3 c nocsma~c~ a~10t'uncs;more likely to have a heart attack than nonusers , who do notsmoke. It has been estimated that users betneen the agesof 30 and 39 sho smokehave ahouta I In 10000, u a nenusers who do not smol:e* the llccr.have been reported ln w•omen binre serlons slde effeets ln¢lude a chaucein a In the age group 10to 4i:,ttiee riskIs using oral eontraceptlves-.but It~ Is not worsening of ~mieralne, estDma, epilep about l In 1,I00 per.ycar fvr usen.a~ho Yct Y.'now.n wttether the druHcasued xy, and kidney urr heart dlsrtu be-amokt compared'to aDaut' I in 1n.000 tltrtn. caus[ of a lendency'for a•ate[ to ~De re~ lor uaen a~DO donot amnk'e and to r. Danern fo'o dcrrzfepinp child Utalned In the body when oral cont:a• dn not Ifeavy aDOn6l~ln Ie;000~per7•ear for nonusen . orol' conlracrprtuea are usedtn or Im- ceptfce< are used: Ott:er side effectswho smoke. . smoktnW, rardlatrlU p.cerdtny preenaney.~ Oral are, growthof precststingflbrpldtabout l5 clBarettes or mocea day) t•ontracrptlvr.: shouldnot be taken,bytumon ofthe uterus:.mentaldeprrs- fur[her Increxses the risk.. If. yp:.t- do pregnant women because they mxyslon: and llver problemswithJaundicenot smoke end havenonoo4tite oth~~r damaGe the decrlupdng child. AnIn- Lyetlovcingof tlie. skln):.. Your doctor, heactt utack dekfacten describrd'Creasee rlsk of birth defeetu. InchtdlnH mayilnd4hat4evels of sucar and fattyaboce, You a-ILL hase a fmnller rlak heart defects and limb defects, hns subslxnces In yo.ur blood are elevated: than listed. 7i you have severaV.hcart been aasociated ayttth the use at sexthc Iengterm effects ot'tnese chanRra attack risk facten.. tfie risk may'~Dehormones. Inciudingg oral contrscep• are not knoa^t: Some wpmao,develpID conslderaDty,grealer than tlsted... LU'cs, In DrCgnancy: Inadditlnn.' the hlRh blood presure whlle takinga onll ln addition to Dlood~elotling Jisnr• dneloplhH tcmale chlld a•hose rttother ¢nntracrotlves,, xhich ordlnarlly re- den„ Ithu been t•.ttmated that hasrecrlred DES idUCthylstllbestroll; turnstb theoriginatlevcls when the women talting onlicontraceptivex areanestroaen, during pregnancy'hSS.a omltontnrepth'e Isstopped:s tw'1ce as tlkcly as nomisers lo have a rtskt ofgee[lnRcanter..of thevaeiita'or Other reactibrs•e altfioughnofh atroke due lo rupture of e. blood vcxsel cervix Ih her teens ar Young adult. proved to De esusrd DYorxl contr;[cey Inthebrain hood...This risk tsestfmated to be. Llves..are.occasionallyaeportedThese b. £,ormaaon eJlumora Studies about', I In 1.000 ctposurrs or less.. Ab- Inelude more frepuent urination and ]tave found that when certain animals normniifYes of' theurlnarye and' sex some dtscomfort when urinating. ner- are.glven.ttre:female set.Dormone es~ organs have becn reportedIn malee vousncsa. dl'rainess..same loss of'scal..p lrogen. wn4ch is an Ingredl¢nCof'oral~ offsprinH so esposed. It Is possible hair, an In¢reae. In bpdy'ha`.r, an In- enrl[raeepth'ea,. cantlnuaLaly fart lanH that other estraaena..such af the es- crease nrdecrease Irl sexdrlt'e, aDpe• coo[crac¢ptlvea. could tlte chanBes,.cataracrs..and aneetl /or trogens In orall prtlods, caneen maYdevelop In the have the same effect lh tha chfld' if a change In contact.lens prescrlptlon brcastieervlx.:vagina,.andllver.L the mother takes them duringg preg- OrlnxDldlty'to.usetontacL'Jenses. These flndtngseuggestthat enl cen• nancy,. Nter yow stop ue[ng oral contracep- tracepttves may causecan¢er In If yort stopP taking orat tontr[cep- tla~esthere maYbea d¢Ixy.he(ore you humans.. Hawtvcr, stwdib to dat¢In olves to become pregtant; your doctor arc able to ~becomc prcRnant or before women CxklnH cwrrentty muketed orx7 may. reconunend that you use another You resume havqng mcustmal perlodse eontrateptlves have natconfirmed methodd of contraccptton for a slrort Thlsl! espcciallyy tme of women w.huo that oral eontra¢eDtlvrs causacnnmr wtiue.,Thescasom (orthis Is that tD¢re. hadirregular mens[rual Cycles prior to. Ift hurnans. Severalstudies F.ace found 1~ evidence from studlesln w•oman who the use af ornl contracepttfes As dis• no In¢reue In Drea.s6 cancer In users.. havee tiad, •'m,lsearstages" aoonn after cussed pcevlously, )'our doctor mayy although ane study suggested oral . aeappit[Rihe plll, that the Josc', fetuses recommcnd that you wait a short eontncepciV¢s might cnu;e an Incre:lr~e.e arC more t7kely to be abnorml[l. whlle after stopping the pill Deforte In Dreutcancer:in ~.vomrnwho alreadyLV)iettur there Isan overallIneiv, se in Yvu try to becomee pre6:nant. Durtng uho become thls llme. use another fomt of contra- have D¢n!rnr breast dL ea.¢ ce:R:. c5'sla). "misenrr/a8e" Irt women ' Wom,en wltha:stronR faml4ylilstory, pregnlntsoon n(ter stopph+g tha.pill crptlan. Yeuahowld cnnsultyour p:ul- a( breast <anecr oc w-ho kavenrra:.tns compared with women who do not CianDelorc resumutq' use ol aral con- nodules. flbroCystlo dise^se, oC abnor• usethc.pill'~ISaloeknown, Eut'it Is Dos- lrnerotices x(trr childbvrrn.. especiillymal mammnKramxs oro who w'creex:- aiblc thnt there mayDrt..Ify howc,cr; 11'you, plhntonurse )'uur baby. Drugs. posed'lo DES IdlethYlslilbcstroli: aa you do bccome prrgnnnt soon.atter ld[ oral con:rx¢eptice3xre known toestrogcno and do aVprmr in the nrilk, andthe lpnrtrange. duR thelr mochcr't preR• stbpping 0ral contracrptivrso nancymust De.folloa2d verY'closely Dy, nochas'c a mfscarrint.c, tticre fs no evh effrct on lnlan[s Isnot'knoam at'this ttielr, docton If they cLoose te usc.ornl dcnce that0:hc babyy has.an.lnerenaed' tim,c. Fltrthsr:nore• oril contrnceptives comtracrvtt.'rsIhstexd nf anothcr rt,k of hrh~g abnurmM. may cause a decrease In youc m9tk metnpd of eetltraCep[lan..~bnny.stud:d.,Ga[thlddderdlsVOae. Warnen who supplyuw[I1:SIn:heGUalltyoflti6 lee have showntliat wCmen taking Uae arall can6raceptfves have a greater. milk:.. chance each year of' havihR a fatal. nanti tumur of the liver, These tumors frrouently seen when using the minl- heart attaek.cn.mperedtok about a I Inn da not.spreadt but theyy mayrupture plll -.comDlrtatlon ural eontr.tceptives 50.000 chance Inusenn who doo nott and 'auseInternal bleedina. which cnntaining less than 50 mlerogranss of hpt a I Ih1000n0 mnyhe fatal. A few tues of cancer of estrogcn. n mak• d1 repeqAt aeGlatea,. VOl ah NO. 11-TLRSDAr, JANVABT 71„1er1 A2-7 S oral eontran-ptives hare less risk of risk than nonusers of having BAII't•tad-eelting bcnifn brcast disca<e than der.ddsraserrpufrinr surgcry. The in- those w'.tto have not uxrd oral tontn- crezxed rixkmal` fint appear within I ceptives: Rcccntly, strong evldenco has year of use..[nd may douDle after 4 or emarqed that eaeropens (one cnmpo• i:ean of use. nen4 oforalcontracrpth'es).f wtien, e. Othrr.side e.ryects o/'eraf'cpntra• gh•en, for perlods ofmore thanune erpticrs.3omevomcnuslnBoralcon- year towomen after themenopau^c, trncrptlvcsexperienccunplcasantsideInerrase ttiee rlsk of~ cancer of' thee eltecta:thacace notdnngernus and aree uteruslw'omDl:Threelsalsoaomeect• not likely to damaga their healtn- dence that a kindd af orxl contra[cpttve Somn- of theSe may be temporary: which Is no longerr markCM1ed- the s!- Yourbreastsmay'feelttender:nausea Quen4lal oral Lrontraeeptlvv, may In- and vomlttng may occur, you may ;afnn creasc thC risk Gf Cancer vf ttte uterus., o[ Ibse. ifiBht,. and your ank'les Rlay Thererrmalns no evtdence, however, sa'ell. A spottydarkentng of tite skln, that theorat conttaceptlves now avail, partioularly of the face, is pos ibleand able Increnae the rlsk of thucancers may'. Drrslst. You n>zy' notice unc.pcet• Oral eontraceptls'es do cause, nL+ed vaginalDleeding or.ehaneesfn y-our though rarely a Denign . lnor.-mallR- menstrual perlod:' IrrcNlar bleeding !s.
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280 4. Comparison of tlte RIJY.S of Oral Contraelptlves and Other COn4rarep- tive Method.s.. T!u manyy studies on the risks and effectiveness of oral ton-. traceptl0es and other methods of con- tlaeeptlonhave been anal.2ed to esel- mate the risk of ddath assoclaled with various method.s n!eontneeption.; This risk has two parta:(a) the risk of the method Itself (e.Q., the risk tha.t oral' contraceptfve. willcause dcath due ta abnnrmal'~Olottlne)- and (b) the rl3kk ot death due to prclmnney or abdrtlon In the event the method faltis. The resultS of this analszls an shown NOTICES In ~.the bar e~raph below. The height of the ban is thc numbcr of deaths per. 100.0d0a-omen eaeh, year. There are stx lets oRb^n,..earh set.referrlne.to ipecifie at:e [raWp off women. . LVlthln eachsetofbara there Is a sinale bar for each of the different contracepuve methods. For oral eontncvpuves, thereare lwa ban-one for smokers and the otlter for nonimaken. Tilee analysia ls based:on present knowledge and new Infurrnntlon eould; of course. alter~ It. Thr analysis shouathat the risk of drnlh from all methods oQ birth cenLrnl la ]bw and below that associat- 4233 ed' with' etiildblrth- except forr oral tvntracrattves In,.a'omenpver 40 who smoke. It ahow-a thattlte lowest risk of death ls tuociatcd wilfs the condem or dlaphrat`.a (traditlonal tontraccption)~ bbeked up by early abortion ts ea.se of failure of'the condont or diayhramto prevent pretmancy. Also, at.anyaee the risk o4.death (due to unrcpected prCgnancy) from the uoe of traditional' contraceptlGn. even witlioul a backup of abortion; Is tencrally the same as or less than that from use of oral eontn- cepth'es. ry,.... t..rr ....+..~. rw ...,..w r,w a....~ w.,.+,. w...w.r s. ,r am+..w ...r ....r..w w.s.... .,.,,.n...,.. u r u M L n r a a 11 iY'sA1. Arr Q....,,w 0 u...,.« K ~~ .._. .:.« .. . rept.UL atWSTea,.VOL.47, 110,2I-rUtSDAT, JANUAlY 21, 1971 sa. C1 • ,
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281 ( 444 hovr ro Usk onAt..CoKrn..cerrncs ,4s S.retr neo Enccttvttr AS Posst- aw.Oncx Yoo Havs.Dactnsb To Uss '17tOt 1. What to Teit Your poetor. Youcaomake use off the pillu sa/elyas possible, byLelllna your doator.IQ you have ahy of the 1011ow- InC a. Condillons that mean you should not uae oral eonlrateptlves: . Clots in the IrIIS or lun{e,. Clots )n,the legs or IunCs In the past. A stroke. iteart attaak or anaina Dtttoris. Knowqor suspected cancer ol the breast ar sex ort;ans. UnusualI vea)nal bieedint that haa hot ye0been dlat;nosed... Known orsuspected pee;nincy. b. Coudttionsthat you doctnr will want to wstchclosely or e-hlchm/sht caux hlm toaussest attother:m,ethodOf e0n0raCeptlom A f:unlly history of breasceanar. Ureastnodulcs, fibeocystlo dlscase of the . breasti or an abnormalmammoa anm. Dlabetes.t ltish blood oressure.. . 1fi{lt eholester0l. ClParcttee smoking. Mi4ralne hendaches: tfeart or k)dney disease. £pllePSY: ~ Menflal depresston. F9brold tumors of the uterus. Gallbladder disease. e. Once.ynu are u:rine oral contracep• tlt'es, you should be alert for signs of a serious adverse effect and call you doctor If they,ocyur.3h'arp pain Ia thcchesG couetiln[ binod„or sudden shortness of breath ((ndicallnf pOssible cluls tn the IunGs). Paln latheo ealf 4poxtlble clot In the lee). Crush4ns chestpain or heavtness tln-. dicatlsta poasible heartutackl; Suddcn ttYTree tleldaehe or volttit- lnR. dirraneu or taintlnR. disturoance of risi0n Or. speMeh or a'ra/Jta'13 or numbness inan arnl or leg tindicalina a possible atroke/: Sudden parUal' or. complete loss of~ vision cindicattnt.a possib(e clot in the eye ). Brt'ast lumps (You shoUld'ask your doctor.toshow youhow toexamine your OuT brraSla). Severe pain In the abdomvn <Indicat- tne a possiale ruptured tumor of'the )iserl. Severe depresslon. YellowleR of the skln (Jaundiec). k How toTake the PLA So That it 1s Most Effective.. . (Manufacturer to supply lnforma- tfon on Ao.uee and administntion and what to dn It patlent.has forgotten to tOke one or two ptlls: Whereapnllt'a-ble; manufaeturers: should supply ap. proprlafe Inform,atlon reFardiiTCOae for other approved Indlcatlons.) At tim+•s there.may,be no men.strual period after.acyeieof pilla. Therefore,, if you miss One mrnstrual Derlod but have taken the p/11i uaetly aa trou seerr fappoaed 10 eOnttnue as usual Intotheo nest cycle.,if youu have not taken the correctlyy and mitsamen- atruA) period. Or If yOYare tak/nQ manl'pllls and It Is 4SdaYsor more from the.start.or your IastmCnstrualper)od ypuu may, bo Dresnant and should stop taklna oral eontmcepttres untilyour doctor delermines whether or not youare Orr9nsnt: Until you atn, get to your doctor„ute. anolher ferm, of cpntnceptlan.. It two COILSeeutlR taCnstrukll periods ars misaed, yob' should stop taking p101s untli It is de- trrminrd'whctheryou are presnant. 31 you do becomepreLnana: while using oral eOntnecp/tces. you ~should discuss the risks to the dcvelopina chLtd willl your doctor. 3. Periodld E.arninali0n. Your doctor will take a comNetemedicai'and fnmilYhlstbry tiefore pre- saribi:aC oraleontraeepUfra. AG that time and atiout once a year thereafter. fce xIU generally examine your blood Dreasure, breasta, abdomen, and pelvic or0ans (ineludins a Papanleolacu smear. I.eC, test for cuxer). SUStauar Oral eanlneepttvrs are the most ef- feetive method, exerpt sterillzatlon. for, preventlnapreenancy. Other methods, w.hcn usediconsclentlously. are aiso reryy effeclce and have fewer risks. The serious risks o1 oral icontra• ecptives ara uncommon and the "pill" Is as'erya eonveMent method of Drb Yen/tnCprcenaney: - ityouhave certain conditlotss or havelwd thcse conditions In th, paat;. You st)ouwld notuae Onlcontnceptiveal becnuse the risk ts too great. These condltlons are listed In the leaf]et: If you do not hac•e these eonditlons..and decide to use the "pilf." pleise read the leaflet earefully su that~ youean . use the "D1U' most.safely andelfee- tlrcty:. Dascdd on his orr hrr, asscssmrnt of your nlCdical nerd., your doctor has prescclbrd'thiA.drus for you. Do not atve.the drug to anyone else. LSen 502 s03.. tiSIaL.loS0-ldSS•. ae ameMed 1:1USC 152...:;500 and under lulnorltYdefrastedt0 tbe Caevnlsel0ner, of Food rnd DM1aY./y1 CFR S;i iJ Dated[ January 18. 197a. Dos+t,.o Kcxamx. CcmmissionerolFood and' 1)rupa IFR Doe'R-:301 l71e01-Y1-1a: 10:ti aml repfar.l 1EG1a1Ek. YOI. ea,. XO. I1 -TUESOar, JANWA4r ]L 19ye r I 95-757 0 - 79:- 19

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