morning-after pill less effective in overweight women

a disturbing story today that morning-after pills may not be as effective in overweight women (see http://in.reuters.com/article/2013/11/26/us-fda-morningafter-idINBRE9AP02B20131126 for story). basically, European health regulators found that a French morning after pill marketed as Norlevo had decreasing effectiveness in women over 165 pounds and was not effective at all in those over 176 pounds, prompting the Europeans to order a label change.  turns out that Plan B in the US is basically the same composition. there was a comment in Physician's First Watch that "According to the CDC, the average American woman weighs 166.2 pounds, which may raise concern about the efficacy of this type of emergency contraception among many U.S. women. The battle to make emergency contraception available has been long and arduous. Hopefully, this recent information will not discourage users, as this may still be the best option available." 

a couple of comments:

1. it is pretty surprising to me that if the average US woman weighs in the "decreasing effectiveness" group, and that there are lots in the "not effective at all" group, that failure rates in the US would have been pretty apparent before this.
2. seems that BMI would be more useful than weight per se, since (i would assume) the issue is the amount of fat present, with its effects on hormone metabolism (ie and the amount of adipose tissue in a 6 foot tall woman weighing 176# is pretty different from a 5 footer of same weight)
2. there was a recent article in ObGyn journal (see oral contraceptives and obesity obgyn2013 in dropbox, or DOI: http://10.1097/AOG.0b013e31828317cc) which assessed efficacy of oral contraceptive pills, patches, and vaginal rings in 7500 women of varying BMIs followed 2-3 years.  no difference in failure rates in those with BMI <25 (8.5%), BMI 25-30 (11%), or BMI >30 (9%). this was an observational study with self-reported outcomes. dose of ethinyl estradiol in the pills ranged from 20-35 micrograms (though no information on whether the higher dose pills were taken more by the more overweight women). other observational studies have had mixed results.

so, quite concerning finding in Europe. i would assume that the Food and Drug Admin will assess this aggressively to see, for example, what the US experience is and if the morning after pill should have differing hormonal content based on BMI (or weight).

Comments

Post a Comment

if you would like to receive the near-daily emails regularly, please email me at gmodest@uphams.org

Popular posts from this blog

cystatin c: better predictor of bad outcomes than creatinine

  another article found significant discordance between creatinine and cystatin C in assessing renal function,  finding that the latter correlated most strongly with both renal and non-renal adverse clinical outcomes (see   ckd cystatin c better than creat AJKD2023  in  dropbox or doi: 10.1053/ j.ajkd.2023.04.002)   Details: -- 158,601 adults who were in the Stockholm Creatinine Measurements (SCREAM) project and had testing of creatinine and cystatin C on the same day during a healthcare encounter, from 2010-2018     -- >400,000 outpatient tests were done for both creatinine and cystatin C levels -- mean age 62, 48% female -- mean eGFR by creatinine (   eGFR cr ) 80; mean eGFR by cystatin C ( eGFR cys  ) 73 -- mean stage of renal insufficiency: 39%  eGFR cr   90+; 38%  eGFR cr  60-89; 12%  eGFR cr  45-59; 7.1%  eGFR cr  30-44; 3.2%  eGFR cr  15-29, 0.7%  eGFR cr ...
Read more

diabetes DPP-4 inhibitors and the risk of heart failure

the FDA just came out with a safety alert about 2 DPP-4 inhibitors and the increased risk of heart failure (released 04/05/2016)(see  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm494252.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery ​ ). details: --saxagliptin and alogliptin were singled out because of 2 clinical trials in diabetic patients with heart disease. in each trial more patients taking these meds were hospitalized for heart failure vs those on placebo     --in the saxagliptin trial: 3.5% were hospitalized for heart failure (vs 2.8% on placebo). risk factors included prior heart failure or kidney disease     --in the alogliptin trial: 3.9% were hospitalized for heart failure (vs 3.3% on placebo) --recommendation by the FDA:     -- we should consider stopping these drugs if the patient develops heart failure ...
Read more

UPDATE: ASCVD risk factor critique

I decided to do an extensive update of my prior ASCVD (atherosclerotic cardiovascular disease) risk analysis and critique of risk calculators, with much more information about the “non-traditional” risk factors. I felt that there should be more data/clarification, since I think we are really undertreating/not preventing the most common cause of death by relying on the current ASCVD risk calculators   -- Cardiovascular risk models:      -- many of us rely on the various cardiovascular risk models to determine the appropriate approach to patients, and these are often integrated into the electronic medical records      -- these risk models have several very important limitations:          -- they are typically based on community data, eg from the Framingham study etc. But, in clinical practice, we are dealing with the individual and not the community:          ...
Read more