What does the black triangle mean?

The black triangle is used in all EU Member States to identify medicines under additional monitoring

The European Union (EU) has introduced a new process to label medicines that are being monitored particularly closely by regulatory authorities. These medicines are described as being under ‘additional monitoring‘.

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Our Bodies, Ourselves

2011 Edition by Boston Women’s Health Book Collective

our-bodies book cover image
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This highly respected publication provides women with information about health, sexuality and reproduction. This 2011 edition includes DES information provided by DES Action USA.

This newly revised and updated edition focuses on women’s reproductive health and sexuality. It includes dozens of personal stories and essential, up-to-date information about gender identity, sexual orientation, birth control, abortion, pregnancy and birth, perimenopause, menopause, health issues such as breast and ovarian cancers, and sexuality and sexual health as we age.

The book also features stories from OBOS’s Global Network partners who engage in public health outreach and advocacy, often at great risk, using materials they developed based on “Our Bodies, Ourselves.”

Hundreds of writers and reviewers collaborated to ensure the book’s accuracy and comprehensiveness, resulting in an essential text that provides evidence-based information and addresses the political, economic and social forces that shape women’s health.

Sources and book reviews

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  • Watch @DES_Journal diaporama and DES album on DES Diethylstilbestrol's photostream on Flickr
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  • Email your photos to des.daughter@gmail.com with a short description and title :-)
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Long-term use of birth control pills linked to higher risk of brain cancer

Female sex hormones used in the contraceptive pill may increase the risk of some cancer types, scientists think

Birth Control pills image
Female sex hormones used in the contraceptive pill may increase the risk of some cancer types, scientists think.

Taking a hormonal contraceptive for at least five years is associated with a possible increase in a young woman’s risk of developing a rare tumour, glioma of the brain.
This Danish project focussed on women aged 15-49 years.

Summary

Aim
Oral contraceptive use influences the risk for certain cancers; however, few studies have examined any link with risk of central nervous system tumors. We investigated the association between hormonal contraceptive use and glioma risk among premenopausal women in a population-based setting.

Methods
Using national administrative and health registries in Denmark to conduct a nationwide case–control study, we identified all women ages 15 to 49 years with a first-time diagnosis of histologically verified glioma between 2000 and 2009. Each case was age-matched to eight population controls using risk set sampling. Based on prescription data, exposure until 2 years prior to the index date was categorized according to hormonal contraceptive type, i.e., combined estrogen–progestagen or progestagen-only, and duration of use (<1, 1 to <5, ≥5 years). We used conditional logistic regression to compute odds ratios (ORs) with 95% confidence intervals (CIs) for glioma associated with hormonal contraceptive use, adjusting for potential confounders.

Results
We identified 317 cases and 2,126 controls. Ever use of hormonal contraceptive was associated with an OR of 1.5 (95% CI: 1.2-2.0) and the OR increased with duration of use (long-term, ≥5 years: OR, 1.9; 95% CI: 1.2–2.9). The association between long-term hormonal contraceptive use and glioma risk was most pronounced for progestagen-only therapy (OR, 2.4; 95% CI: 1.1–5.1), especially when this regimen constituted the sole hormonal contraceptive therapy (OR, 4.1; 95% CI: 0.8–20.8).

Conclusion
Long-term hormonal contraceptive use may increase the risk of glioma.

Sources and more information
  • Long-term use of hormonal contraceptives is associated with an increased risk of brain tumours, British Pharmacological Society, 22 January 2015.
  • Hormonal contraceptive use and risk of glioma among younger women a nationwide case-control study, British Journal of Clinical Pharmacology, DOI: 10.1111/bcp.12535, bcp.12535 and full study PDF.
  • Taking contraceptive pill for five years doubles risk of brain tumour, warn scientistsn, the telegraph, 22 Jan 2015.

Puberty comes earlier for Girls, thanks to EDCs and Phthalates Exposure

Findings suggest an association between 2, 5-DCP, a potential EDC, and earlier age of menarche in the general U.S. population. Also phthalates may cause weight gain and so influence the timing of puberty…

Puberty-for-Girls
Puberty comes earlier for girls, thanks to EDCs and phthalates… image via Mark Nockleby .

At the turn of the 20th century, the average age for an American girl to get her period was 16 to 17. Today, it is less than 13, according to national data. The trend has been attributed to the epidemic of overweight children and a greater exposure to pollution – the n° 1 factor that is pushing girls into puberty early seems to be their body mass index.

Among the toxins causing this trend, the biggest offenders are plastic compounds, in particular phthalates, man-made chemicals found all over the place: in plastic food and beverage containers, carpeting, shampoos, insect repellents, vinyl flooring, shower curtains, plastic toys and in the steering wheels and dashboards of most cars. Our bodies cannot metabolize phthalates, which interfere with the endocrine system—the body’s system of glands and hormones—and harm fat cells. Indirectly, phthalates may cause weight gain and so influence the timing of puberty…

Abstract

Background:
The observed age of menarche has fallen, which may have important adverse social and health consequences. Increased exposure to endocrine-disrupting compounds (EDCs) has been associated with adverse reproductive outcomes.

Objective:
Our objective was to assess the relationship between EDC exposure and the age of menarche in adolescent girls.

Methods:
We used data from female participants 12–16 years of age who had completed the reproductive health questionnaire and laboratory examination for the Centers for Disease Control and Prevention’s National Health and Nutrition Examination Survey (NHANES) for years 2003–2008 (2005–2008 for analyses of phthalates and parabens). Exposures were assessed based on creatinine-corrected natural log urine concentrations of selected environmental chemicals and metabolites found in at least 75% of samples in our study sample. We used Cox proportional hazards analysis in SAS 9.2 survey procedures to estimate associations after accounting for censored data among participants who had not reached menarche. We evaluated body mass index (BMI; kilograms per meter squared), family income-to-poverty ratio, race/ethnicity, mother’s smoking status during pregnancy, and birth weight as potential confounders.

Results:
The weighted mean age of menarche was 12.0 years of age. Among 440 girls with both reproductive health and laboratory data, after accounting for BMI and race/ethnicity, we found that 2, 5-dichlorophenol (2, 5-DCP) and summed environmental phenols (2, 5-DCP and 2, 4-DCP) were inversely associated with age of menarche [hazard ratios of 1.10; 95% confidence interval (CI): 1.01, 1.19 and 1.09; 95% CI: 1.01, 1.19, respectively]. Other exposures (total parabens, bisphenol A, triclosan, benzophenone-3, total phthalates, and 2, 4-DCP) were not significantly associated with age of menarche.

Conclusions:
Our findings suggest an association between 2, 5-DCP, a potential EDC, and earlier age of menarche in the general U.S. population.

Sources and more information

Know Your Terms Initiative Pregnancy Poster

Raising Awareness about the new full term pregnancy definition

Know-Your-Terms-Initiative-poster
Raising Awareness about the new full term pregnancy definition.
Watch @DES_Journal diaporama and health posters album on Flickr.

Sources: The Know Your Terms Initiative, website and sharing information.

Sadly for many DES daughters having their own children is not possible! Many of us who have experienced miscarriages, want to have kids but are struggling or unable to… More about DES pregnancy risks and studies about DES and pregnancy.

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Does screening for disease save lives in asymptomatic adults? Not really…

Should we be looking for disease in people who don’t have any symptoms?

Should we be looking for disease in people who don’t have any symptoms?
A large new study indicates the answer is NO. Image by Yasunari(康就) Nakamura(中村).

Screening for disease is a key component of modern healthcare. Yet, new surprising new research shows that few currently available screening tests for major diseases where death is a common outcome have documented reductions in disease-specific mortality. Evidence was evaluated on 16 screening tests for 9 major diseases where mortality is a common outcome. The researchers found 45 randomized controlled trials and 98 meta-analyses that evaluated disease-specific or all-cause mortality. Reductions in disease-specific mortality were uncommon and reductions in all-cause mortality were very uncommon.

Sources and more information

  • Does screening asymptomatic adults for disease save lives?,
    Oxford University Press (OUP), 13 January 2015.
  • Does screening for disease save lives in asymptomatic adults? Systematic review of meta-analyses and randomized trials, Int. J. Epidemiol. (2015),
    doi: 10.1093/ije/dyu140, January 15, 2015.
  • Cancer $creening Doesn’t Save Lives, Meta-Study Reveals,
    greenmedinfo, January 15th 2015.

Medicines related to valproate: risk of abnormal pregnancy outcomes

Children exposed in utero to valproate are at a high risk of serious developmental disorders (in up to 30-40% of cases) and/or congenital malformations (in approximately 10% of cases).

GOV.UK Drug Safety Update

Sources:  GOV.UK Department of Health
Medicines and Healthcare Products Regulatory Agency, 22 January 2015

Public-Health-England image
Children exposed in utero to valproate are at a high risk of serious developmental disorders (in up to 30-40% of cases) and/or congenital malformations (in approximately 10% of cases). GOV.UK Drug Safety Update.

This is to inform you of important new information and strengthened warnings related to safety of medicines related to valproate (sodium valproate, valproic acid [brand leader: Epilim] and valproate semisodium [brand leader: Depakote]), following completion of a Europe-wide review:

  • children exposed in utero to valproate are at a high risk of serious developmental disorders (in up to 30-40% of cases) and/or congenital malformations (in approximately 10% of cases)
  • valproate should not be prescribed to female children, female adolescents, women of childbearing potential or pregnant women unless other treatments are ineffective or not tolerated
  • valproate treatment must be started and supervised by a doctor experienced in managing epilepsy or bipolar disorder
  • carefully balance the benefits of valproate treatment against the risks when prescribing valproate for the first time, at routine treatment reviews, when a female child reaches puberty and when a woman plans a pregnancy or becomes pregnant
  • you must ensure that all female patients are informed of and understand:
    • risks associated with valproate during pregnancy
    • need to use effective contraception
    • need for regular review of treatment
    • the need to rapidly consult if she is planning a pregnancy or becomes pregnant

Please refer to the General Medical Council’s consent and prescribing guidance.

Risk of abnormal pregnancy outcomes

Valproate is associated with a dose-dependent risk of abnormal pregnancy outcomes, whether taken alone or in combination with other medicines. Data suggest that when valproate is taken for epilepsy with other medicines, the risk of abnormal pregnancy outcomes is greater than when valproate is taken alone.

The risk of congenital malformations is approximately 10 % while studies in preschool children exposed in utero to valproate show that up to 30-40% experience delays in their early development such as talking, and/or walking, have low intellectual abilities, poor language skills and memory problems.

Intelligence quotient (IQ) measured in a study of 6 years old children with a history of valproate exposure in utero was on average 7-10 points lower than those children exposed to other antiepileptics.

Available data show that children exposed to valproate in utero are at increased risk of autistic spectrum disorder (approximately three-fold) and childhood autism (approximately five-fold) compared with the general study population Limited data suggests that children exposed to valproate in utero may be more likely to develop symptoms of attention deficit/hyperactivity disorder (ADHD).

Given these risks, valproate for the treatment of epilepsy or bipolar disorder should not be used during pregnancy and in women of child-bearing potential unless clearly necessary ie in situations where other treatments are ineffective or not tolerated.

Carefully balance the benefits of valproate treatment against the risks when prescribing valproate for the first time, at routine treatment reviews, when a female child reaches puberty and when a woman plans a pregnancy or becomes pregnant.

If you decide to prescribe valproate to a woman of child-bearing potential, she must use effective contraception during treatment and be fully informed of the risks for the unborn child if she becomes pregnant during treatment with valproate.

Treatment during pregnancy

If a woman with epilepsy or bipolar disorder who is treated with valproate plans a pregnancy or becomes pregnant, consideration should be given to alternative treatments.

If valproate treatment is continued during the pregnancy:

  • the lowest effective dose should be used and the daily dose should be divided into several small doses to be taken throughout the day – the use of a prolonged release formulation may be preferable to other treatment forms
  • initiate specialised prenatal monitoring in order to monitor the development of the unborn, including the possible occurrence of neural tube defects and other malformations
  • folate supplementation before the pregnancy may decrease the risk of neural tube defects common to all pregnancies; however the available evidence does not suggest it prevents the birth defects or malformations due to valproate exposure

Further information

The Cochrane review published in November 2014 assessed 22 prospective cohort studies and 6 registry studies. The review supported findings from the European review that children exposed to valproate in utero were at an increased risk of poorer neurodevelopmental scores compared to the general study population both in infancy and when school aged.

A dose-related risk of developmental disorders was reported for valproate in 6 of the 28 studies included in the Cochrane review. However, based on the available data, it is not possible to establish a threshold dose below which no risk of developmental disorders exists.

Usage during pregnancy in the UK

Data from the Clinical Practice Research Datalink suggest that approximately 35,000 women aged 14 to 45 per year had a prescription for sodium valproate between 2010 and 2012, the majority for epilepsy. Of these, at least 375 per year had a prescription for sodium valproate while pregnant.

Future action

Pharmaceutical companies holding licences for valproate containing medicines must monitor the usage of these medicines to assess the effectiveness of these new measures on reducing the number of pregnant women taking valproate. We will continue to monitor valproate usage using the Clinical Practice Research Datalink. We will also work with stakeholders such as clinical guideline bodies to develop tools to aid decision-making for healthcare professionals and patients. We have already developed information booklets for healthcare professionals and patients (see further information below).

The product information will now be updated to reflect our current understanding of the available evidence and to make information as clear as possible.

Educational materials are available to healthcare professionals and patients in order to inform about the risks associated with valproate in female children, female adolescents, women of childbearing potential and pregnant women (see further materials below).

Call for reporting

Valproate is now a black triangle medicine and is subject to additional monitoring. Therefore please report any suspected side effects to valproate via the Yellow Card scheme.

How I lost my Uterus and found my Voice

A memoir of love, hope, and empowerment by @MLWhitlock

A memoir of love, hope, and empowerment

How-I-Lost-My-Uterus-and-Fo
Watch @DES_Journal diaporama and DES album on Flickr.

At age twenty-six, author Michelle L. Whitlock thought she had it all: she was in the best physical shape of her life, she had a promising career, and she had a budding romance that looked like it could finally be the real thing. Then doctors informed her that she had HPV. Weeks later her worst nightmare became her reality: she was diagnosed with invasive cervical cancer. In this memoir, Michelle narrates the story of her ordeal. She tells how she took charge of her healthcare and pursued an experimental surgery that treated the cancer while preserving her fertility. The surgery was a success, but just years later-a week after the love of her life proposed-Michelle discovered her cancer was back.

How I Lost My Uterus and Found My Voice follows Michelle as she wonders if she will live or die, have children, or enjoy sex again. This is one woman’s story of falling in love, battling HPV and cervical cancer, facing sexual dysfunction, confronting her conflicting feelings about motherhood, and becoming her own best advocate. Inspirational and honest, this memoir tells the emotional story of love, loss, resilience, and survival.

Sources and book reviews
On Flickr®

How about informed consent for all medication

Now more than ever, Informed consent is needed. Its a great opportunity for patients and/or their caregivers to have an intentional conversation with their doctor about their medications.

Choosing-Wisely-image
Now more than ever, Informed consent is needed. Its a great opportunity for patients and/or their caregivers to have an intentional conversation with their doctor about their medications.

Doctors prescribe way too many medicines for patients who don’t really need them. A lot of the pressure comes from intense drug company marketing. Some comes from patients who aren’t happy leaving the office without a pill. And doctors have too little time with each patient to explain non-pill solutions to problems. Wild prescribing is not new. For thousands of years, doctors have given patients useless (and often quite harmful) drugs and patients have taken them.

Modern medicine was meant to be different — it would be based on scientific evidence that could tease out real effect from placebo effect. Unfortunately, evidence-based medicine is only as good as the evidence it is based on. And in many instances our evidence is not very good because it comes from biased drug company studies.”

… continue reading How About Informed Consent for All Medication,
by Allen Frances on huffingtonpost01/21/2015.

Pap Rap video – Get your PAP smear says Nadia Kamil

The rap video that makes you want to book a smear test!

Ladies! And anyone with a cervix! I recommend getting screened for cervical cancer if you can. In the UK this is at age 25 and older, and if the results are clear you only have to go back again every three years.
Here’s the storify of Nadia Kamil live-tweeted appointment.

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