Thrombotic risk minimization for <scp>D</scp>iane‐35 and generics

Bezemer, Irene D.; Smits, Elisabeth; Beest, Fernie J. A. Penning-van; Asiimwe, Alex; Herings, Ron M. C.

doi:10.1002/pds.4319

Cited by 4 publications

(3 citation statements)

References 9 publications

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“…Social media appeared more reactive, showing more activity for the drug in question after a DHPC was published than before. Our finding that DHPCs related to drugs without a specialist indication were covered more often seems to be in line with earlier studies showing a high newspaper coverage of non-specialist drugs, such as cyproterone acetate/ ethinylestradiol (Diane-35) and rofecoxib [Vioxx (selective serotonin reuptake inhibitor)] [13,35]. With regard to social media, one might also expect more postings by laypeople on common non-specialist drugs because such drugs are more widely used.…”

Section: Discussionsupporting

confidence: 90%

“…However, this media attention may also have contributed to an observed unintended decrease of use in adults [11]. While large changes in drug use have been reported for safety issues that were extensively covered by the media [13][14][15][16][17][18], systematic reviews suggested a more modest, if any, effect for a wide range of studied safety communications that generally may not have received much media attention [5,9,10]. It remains, however, largely unknown to what extent media in general pay attention to drug safety issues reviewed by regulatory authorities.…”

Section: Introductionmentioning

confidence: 99%

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Drug Safety Issues Covered by Lay Media: A Cohort Study of Direct Healthcare Provider Communications Sent between 2001 and 2015 in The Netherlands

et al. 2020

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Background Some drug safety issues communicated through direct healthcare professional communications (DHPCs) receive substantial media coverage, while others do not. Objectives The objective of this study was to assess the extent of coverage of drug safety issues that have been communicated through DHPCs in newspapers and social media. A secondary aim was to explore which determinants may be associated with media coverage. Methods Newspaper articles covering drug safety issues communicated through 387 DHPCs published between 2001 and 2015 were retrieved from LexisNexis Academic™. Social media postings were retrieved from Coosto™ for drugs included in 220 DHPCs published between 2010 and 2015. Coverage of DHPCs by newspapers and social media was assessed during the 2-month and 14-day time periods following issuance of the DHPC, respectively. Multivariate logistic regression was used to assess potential DHPC-and drug-related determinants of media coverage. Results 41 (10.6%) DHPC safety issues were covered in newspaper articles. Newspaper coverage was associated with drugs without a specialist indication [adjusted odds ratio 5.32; 95% confidence interval (2.64-10.73)]. Negative associations were seen for time since market approval [3-5 years 0.30; (0.11-0.82), 6-11 years 0.18; (0.06-0.58)] and year of the DHPC [0.88; (0.81-0.96)]. In the social media, 180 (81.8%) drugs mentioned in 220 DHPCs were covered. Social media coverage was associated with drugs without a specialist indication [6.92; (1.56-30.64)], and for DHPCs communicating clinical safety issues [5.46; (2.03-14.66)]. Conclusions Newspapers covered a small proportion of DHPC safety issues only. Most drugs mentioned in DHPCs were covered in social media. Coverage in both media were higher for drugs without a specialist indication.

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Section: Discussionsupporting

confidence: 90%

Section: Introductionmentioning

confidence: 99%

Drug Safety Issues Covered by Lay Media: A Cohort Study of Direct Healthcare Provider Communications Sent between 2001 and 2015 in The Netherlands

et al. 2020

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“…According to different studies, CPA should not be used only as a contraceptive. It can be prescribed in specific complaints like moderate to severe acne and hirsutism in women in reproductive age, but only if alternative treatments, such as topical therapy and systemic antibiotic treatment, have failed [4,8].…”

Section: Cyproterone Acetate (Cpa)mentioning

confidence: 99%

Anti-androgenic therapy in young patients and its impact on intensity of hirsutism, acne, menstrual pain intensity and sexuality — a preliminary study

et al. 2019

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Objectives: Using anti-androgenic contraception is one of the methods of birth control. It also has a significant, non-contraceptive impact on women's body. These drugs can be used in various endocrinological disorders, because of their ability to reduce the level of male hormones.The aim of our study is to establish a correlation between taking different types of anti-androgenic drugs and intensity of hirsutism, acne, menstrual pain intensity and sexuality .Material and methods: 570 women in childbearing age that had been using oral contraception for at least three months took part in our research. We examined women and asked them about quality of life, health, direct causes and effects of that treatment, intensity of acne and menstrual pain before and after. Our research group has been divided according to the type of gestagen contained in the contraceptive pill: dienogest, cyproterone, chlormadynone and drospirenone. Additionally, the control group consisted of women taking oral contraceptives without antiandrogenic component. Results:The mean age of the studied group was 23 years ± 3.23. 225 of 570 women complained of hirsutism.The mean score for acne intensity before the use of contraception was 2.7 ± 1.34. The mean score for acne intensity after 3 months of using contraception was 1.85 ± 1.02 (p < 0.001). 192 women reported excess hairiness in one or more area before treatment. Mean value based on Ferriman-Gallway scale before the treatment was 6.23 ± 6.21 and 5.39 ± 5.6 after the treatment (p < 0.001). Conclusions:All groups of drugs effectively reduced pain and acne severity. Cyproterone and drospirenone turned out as the most effective drugs in treating hirsutism. Surprisingly, according to our research, dienogest does not have any impact on body hairiness.

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Quality of Reporting on the Evaluation of Risk Minimization Programs: A Systematic Review

et al. 2020

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Thrombotic risk minimization for Diane‐35 and generics

Cited by 4 publications

References 9 publications

Drug Safety Issues Covered by Lay Media: A Cohort Study of Direct Healthcare Provider Communications Sent between 2001 and 2015 in The Netherlands

Drug Safety Issues Covered by Lay Media: A Cohort Study of Direct Healthcare Provider Communications Sent between 2001 and 2015 in The Netherlands

Anti-androgenic therapy in young patients and its impact on intensity of hirsutism, acne, menstrual pain intensity and sexuality — a preliminary study

Quality of Reporting on the Evaluation of Risk Minimization Programs: A Systematic Review

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