B. Norman Barwin, MD

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 Oral Contraceptives:  


 Risks, Benefits & New  
 Regimes  

 B. Norman Barwin  





 ORAL CONTRACEPTIVES:  
 . 
 Objectives  
 . 
 Know the risks, benefits and side effects of  
 oral contraceptives  
 . 
 Utilize basic concepts in OC prescribing  
 . 
 Know how to modify regiments to manage  
 side effects  
 .Objectives  
 .Know the risks, benefits and side effects of  
 oral contraceptives  
 .Utilize basic concepts in OC prescribing  
 .Know how to modify regiments to manage  
 side effects  








 ORAL CONTRACEPTIVES  

 .Low Failure Rate  
 .Percentage experiencing an accidental  
 pregnancy in the 1st year of continuous  
 use:  
 .  Lowest expected 0.1%  
 .  Typical 3.0%  






 ORAL CONTRACEPTIVES  


 .Low Incidence of Intolerable Side Effects  
 . Especially compared to progestin only  
 methods (irregular bleeding, acne,  
 weight gain)  
 . Most side effects resolve in the first 1 to 3   months of use  
 . Counseling is CRITICAL  






 ORAL CONTRACEPTIVES  

 .Serious complications are RARE in healthy  
 non- smokers  
 . No increase in stroke/myocardial infarction  
 . Morbidity increases in the presence of  
 underlying risk factors: SMOKING, hypertension,  
 hyperlipidemias, morbid obesity, diabetes  
 . 3 to 4 fold increase in thrombeombolic events  





 ORAL CONTRACEPTIVES  

 .Simple to initiate/Simple to discontinue  






 ORAL  
 CONTRACEPTIVES  


 .Few Contraindications  
 . Past history of or current  
 thrombophlebitis or thromboembolic  disorders  
 . Cerebrovascular or coronary artery  disease  
 . Known or suspected carcinoma of the  
 breast, endometrium, or other  
 estrogen dependent  neoplasia  





 ORAL  
 CONTRACEPTIVES  

 .Few Contraindications  
 . Undiagnosed abnormal genital bleeding  
 . Cholestatic jaundice of pregnancy or  
 jaundice with prior pill use  
 . Hepatic adenomas or carcinomas  
 . Known or suspected pregnancy  





 ORAL CONTRACEPTIVES  


 .Few Contraindications  
 . “Warnings” listed in package insert  
 . Cigarette smoking  
 . Hypertension  
 . Hyperlipidemia  
 . Morbid obesity  
 . Diabetes  






 ORAL CONTRACEPTIVES  


 .Noncontraceptive USES/BENEFITS  
 . The majority of women are unaware of  
 most benefits of OC use  
 . Healthcare providers often neglect to  
 discuss noncontraceptive benefits  






 ORAL CONTRACEPTIVES  


 .Noncontraceptive USES/BENEFITS  
 . Menstrual cycle symptom control  
 . Protection of fallopian tube function  
 . Beneficial effects on the breasts  
 . Treatment of androgen excess disorders  
 . Cancer prevention  
 . Reduction in gynecologic procedures  
 . Perimenopausal benefits/uses  






 ORAL CONTRCEPTIVES  

 .Reduction in Healthcare Costs  
 . For the patient:  
 .Less tampons, pads, pain meds, office visits,  
 procedures  
 . For the HMO Insurance Company:  
 .Less visits and procedures  
 . For the employer:  
 .Less absenteeism  






 ORAL CONTRCEPTIVES  

 .SUMMARY  
 . Low failure rate  
 . Low incidence of side effects  
 . Serious complications are rare  
 . Simple to initiate and discontinue  
 . Few absolute contraindications  
 . Numerous non contraceptive uses/benefits  
 . Reduction in healthcare costs  






 ORAL  
 CONTRACEPTIVES  

 .SUMMARY  
 . LONG-TERM USE OF OC’s recommended  
 because:  
 . No additional risks with long-term use  
 . Added benefits with long-term use  
 . Prevention of gynecological problems with OC’s is  
 more effective than treatment with OC’s  
 . Many gynecological problems develop, worsen,  
 and are less tolerated in the second half of the  
 reproductive years  






 REASONS OC’s NOT USED  

 . Contraindications  
 . Side effects  
 . Compliance problems  
 . Fear/Concern  





 NEW REGIMENS TO MANAGE  
 SIDE EFFECTS AND IMPROVE  
 COMPLIANCE 



 The Standard 28 Day Regime  

 .21 Active / 7 Hormone Free  
 .Until recently, all formulations were a 28 day cycle  
 . 21 active / 7 hormone free  

 .Rationale  
 .To mimic the natural menstrual cycle by inducing  
 monthly withdrawal bleeding  
 .Low incidence of breakthrough bleeding  

 .Drawback  
 . Monthly withdrawal symptoms  





 Symptoms During the Pill Free  
 Interval 



 Hormonal Withdrawal Symptoms  
 In Oral Contraceptive Users  

 .Objective  
 . Measure the frequency and severity of  
 symptoms during the pill free interval  
 compared to the active pill interval  





 Hormone Withdrawal Symptoms In  
 Oral Contraceptive Users  


 .Study Design  
 . Prospective study of OC users  
 . 69 new starts: No OC use in last 3  
 months  
 . 193 current users: OC use 12 months  






 Hormone Withdrawal Symptoms In  
 Oral Contraceptive Users  

 .Data Collection  
 . Demographics  
 . Daily calendars to subjectively record  
 headaches, pelvic pain, bleeding,  
 analgesic use, and other  
 symptomatology  






 Hormone Withdrawal Symptoms In  
 Oral Contraceptive Users  

 .Headaches  
 .Pelvic Pain  
 .Bloating and Swelling  
 .Breast Tenderness  





 Reasons To Modify The Standard  
 21/7 OC Regime  

 .Common estrogen withdrawal symptoms during  
 the hormone free interval  
 .Medical disorders:  
 . Anemia, endometriosis, catamenial,  
 seizures, etc.  
 .Convenience/”Forgetability”  






 Changing The Standard OC  
 Regime: Current/Future Ideas  


 .Shorten the hormone free interval from 7 days to  
 3 to 5 days to provide greater ovarian  
 suppression and decrease the incidence/severity  
 of hormone withdrawal symptoms  
 .Extend the # of days of active OC’s to greater  
 than 21 days  
 .Add estrogen during the hormone free interval  






 Extending The Duration Of Active  
 Oral Contraceptive Pills to Manage  
 Hormone Withdrawal Symptoms  

 .Objective  
 .Test the hypothesis that extending the number  
 of consecutive active OC’s will decrease the  
 frequency of menstrual related problems  






 Extending The Duration Of Active  
 Oral Contraceptive Pills to Manage  
 Hormone Withdrawal Symptoms  

 .Method  
 . Prospective analysis of 50 patients on  
 OC’s who experience hormone withdrawal  
 symptoms during the pill free interval  
 and were allowed to extend the number of  
 consecutive active OC’s  






 Method of Extending Number of  
 Active Weeks  

 .Instructed to take 6 consecutive weeks of active  
 OC’s followed by a hormone free week  
 .The interval of active pills was increased by 3  
 weeks each consecutive cycle (6 wks, 12 wks)  
 followed by a hormone free week  
 .If a patient experienced intolerable side effects,  
 she remained on the regimen that worked best  
 for her  






 Study Results Of The 50 Patients*  


 .37 patients (74%) stabilized on an extended regimen  
 .6 week 8  
 . 9 week 13  
 .12 week 16  

 .13 patients (26%) not stabilized on an extended  
 regimen  
 . Most common reasons  
 .Breakthrough bleeding  
 .Breakthrough spotting  
 .Headaches  






 Extended OC Regime:  

 .If initiating OC’s, begin with the standard  
 regimen for 2 months because of high incidence  
 of BTB/BTS and other side effects  
 .Have patient return during the 3rd cycle to  
 assess compliance/side effects  






 Extended OC Regime:  

 .If patient having withdrawal symptoms during  
 the hormone free interval or wants to delay  
 menses, discuss extending the active pills  
 .Instruct to extend pills till BTB/BTS occurs,  
 take a 4 to 7 day hormone free interval, and  
 restart (re label pack to correct day of week if  
 necessary)  






 Extended OC Regime:  

 .Warn the patient that she can go off the “real”  
 pill for less than 7 days but never more than 7  
 days!!  
 .Make sure your patient understands and is  
 comfortable with this extended regimen; if not,  
 use standard regimen  






 Extended OC Regime:  


 .Increases counseling time in the office; your  
 patient must understand how to extend  
 .Side effects?? - no extensive data; studies  
 underway  






 Extended OC Regime:  

 .Increased OC cost because more active weeks  
 per year and potentially more trips to the  
 pharmacy (prescribe 3 months at a time)  
 .But, less tampons/pads/analgesics/ migraine  
 medications, etc.  




Articles

 ORAL CONTRACEPTIVES:   .  Objectives   .  Know the risks, benefits and side effects of   oral contraceptives   .  Utilize basic concepts in OC prescribing   .  Know how to modify regiments to manage   side effects   .Objectives   .Know the risks, benefits and side effects of   oral contraceptives   .Utilize basic concepts in OC prescribing   .Know how to modify regiments to manage   side effects  

Author | B. Norman Barwin, MD

Articles

Oral Contraceptives: Risks, Benefits & New Regimes

Oral Contraceptives: Risks, Benefits & New Regimes